Our Regulatory Affairs Consulting Services portfolio covers:

1. Regulatory Strategies / Expert Views

Regulations pertaining to pharmaceutical products are continuously changing…

Regulations pertaining to pharmaceutical products are continuously changing and creating challenges for global pharmaceutical industry. This affects the regional and global regulatory requirements for product approval. Therefore, it is important for pharmaceutical businesses to implement a robust regulatory strategy.

Achieving successful product development and market access hinges on a well-crafted and robust regulatory strategy. At QACAL , our Regulatory Strategy teams don’t just follow trends—they stay ahead of them, aligning each company’s goals with the latest regulatory insights. We know that every market has its own regulatory framework associated with unique challenges, and we’re here to help identify and address those critical gaps early, transforming regulatory obstacles into opportunities for an extensive pharmaceutical product portfolio. Our teams deliver comprehensive assessments to refine and fortify regulatory strategies, ensuring our clients overcome any compliance challenges they face. With QACAL ’s strategic support, companies can navigate complex regulatory requirements and drive their products toward successful approval and market entry.

QACAL  offers comprehensive and customized regulatory services. Our services in this specialized pharmaceutical area are included below:

•  Registration Strategy in Emerging Markets and European Union
•  Regulatory Feasibility Analysis
•  Legal Status Switches – Rx/POM to OTC/P & GSL
•  Product Filing and Variation strategies

•  Advisory on CMC data generation for successful filing
•  Change Control Strategies
•  Subject Matter Expertise
•  Query Responses strategies
•  Other ad-hoc regulatory affairs strategies

As a globally recognized regulatory consulting service provider , QACAL  offers expertise in the development of strategies for registration of pharmaceutical products in emerging markets, European Union and US market. Our services include legal status switches from Rx to OTC or P&GSL, product filing and variation strategies, CMC data generation for successful filing, change control strategies and subject matter expertise.

Basics of Regulatory Strategies

The regulatory frameworks in the pharmaceutical sector are stringent to ensure the safety, efficacy, and quality of drugs. Regulatory strategies are pivotal as they help pharmaceutical companies to navigate the complex and dynamic landscape of drug development and approval. A robust and comprehensive regulatory strategy is absolutely essential in order to streamline drug submission and approval processes thereby bringing innovative therapies to the market.

Pharmaceutical companies must ensure they are aware and abreast of the ever-changing guidelines, compliance standards, and regulatory requirements. An effective regulatory strategy addresses anticipated regulatory challenges and potential hurdles while maintaining compliance with competent authorities worldwide. Some of the key things to consider when developing a global regulatory strategy is the complexity and nature of the regulatory landscape, early planning, cross-functional collaboration, risk assessment, frequent contact with competent authorities to discuss plans and seek regulatory guidance, regulatory intelligence, and more. Partnering with regulatory services providers that have extensive experience in stringent and emerging markets can be beneficial to pharmaceutical companies for developing and executing their regulatory strategies.

Regulatory strategy consulting services provide the specialized strategic expertise to pharmaceutical organizations that wish to penetrate a specific market that is unfamiliar to them. These consulting services in regulatory affairs strategies offer valuable insights, interpret complex regulations, and provide tailored strategies for a spectrum of pharmaceutical products to help navigate the dynamic regulatory landscape.

1. New Product Authorizations

Pharmaceuticals and other medicinal products need to be prior authorized by…

Pharmaceuticals and other medicinal products need to be prior authorized by the regulatory authorities of the market/region they want to be sold in. Each market/region has a different framework and distinct guidelines for the review and assessment of pharmaceuticals. Each framework is unique therefore it is difficult for regulatory departments and organizations to implement authorization requirements and procedures without any errors. As a result, the timeline for the processes involved in evaluating a new product is extended. Additionally, requirements imposed by individual countries/regions, and the many guidelines and regulations from global organizations such as ICH and WHO can make the processes lengthier. Thus, the regulatory requirements and procedures for marketing authorizations of new products in various countries is quite diverse. Understanding these different regulations, developing a plan that adheres to the guidelines set by global authorities such as ICH and WHO makes it an exhaustive, complex process.

QACAL  has been providing high-quality regulatory services for over a decade. Here our expert team is highly experienced and knowledgeable, with extensive experience in pharmaceutical regulatory. As a leading regulatory consulting firm, QACAL  has filed new product authorization applications to more than 100 countries and crafted comprehensive responses to any queries raised by health authorities.

We offer pre-submission technical data reviews, Gap Analysis, Regulatory Content authoring, Dossier compilation, validation, and electronic publishing of new product authorization applications for global filing. We also offer end-to-end New Product Authorization advisory as well as hands on services to pharmaceutical organizations that include

Following are the services and activities provided by QACAL :

•  Reviews on product dossiers/technical documentation
•  Gap Analysis & Remediation Advisory
•  CTD Authoring – CMC Sections, Non-Clinical & Clinical Overviews & Summaries
•  Biowaiver Justifications

•  Run procedures – MRP/DCP/CP/RUP in EU, WHO PQ,
•  SmPC/PIL/PI authoring and/or Reviews
•  Artwork reviews
•  Agency Query responses

1. Gap Analysis and Remediation

A gap analysis is a regulatory review process that identifies data gaps in the technical…

Overview – Regulatory Gap Analysis

A gap analysis is a regulatory review process that identifies data gaps in the technical documentation required for preparing the dossier & the application before applying for regulatory approval. Gap analysis is also carried out for in-market products to identify the gaps between market requirements vs products’ filed & authorized specifications. It can also be an identification of differences between activities and expectations in standard operating procedures. Thus, gap analysis, as interpreted and understood in different ways, is a comparative evaluation between current practices and regulatory guidelines. such evaluations are integral to regulatory affairs services, ensuring compliance with evolving guidelines and streamlining the approval process for new and existing products.

The best way to successfully get a product cleared by the regulators or experience a passing inspection from them is to always be prepared for inspections. Preparation for situations includes continuous regulatory gap analysis will help improve any possible deficiencies that are present within standard procedure implementation or applicable guidelines.A comprehensive regulatory gap analysis report with the appropriate remediation regulatory strategy provides pharmaceutical companies with insight into the gaps that could hinder and product approval.

QACAL  offers comprehensive gap analyses services including review of customers’ current product specs, labels and other technical documentation related to:

•  Initial Submission,
•  Dossier Extension of Registered Products,

•  Registered Dossier of Legacy Drug products
•  Lifecycle Management

A remediation strategy is developed and tailored according to the customer’s requirements once all gaps have been identified.The team provides a regulatory gap analysis report with remediation solutions that address each aspect of the customer’s requirement.

Basics of Regulatory Gap Analysis

A dossier gap analysis in regulatory affairs involves a comprehensive and meticulous review of documents that have been submitted to competent authorities by pharmaceutical companies for their product approval. This helps to identify any missing information that may be required to ensure that pharmaceutical companies are maintaining compliance with regulatory standards. The team at QACAL  assesses whether documents, data, or studies are in accordance with the regulatory requirements. This analysis helps to fill any gaps in information to support successful regulatory submissions and subsequent product approvals. Dossier gap analysis is a strategic procedure that helps in mitigating risks of non-compliance, speeds up market approvals, and ultimately ensures adherence to the ever-changing and dynamic regulatory framework.

1. Regulatory Due Diligence

Regulatory issues arise unexpectedly and can create significant strain on a company’s…

Role of Regulatory Due Diligence Services

Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and regulatory audits. Speedily identifying risk factors and efficient methods of risk assessment are key in order to avoid any unexpected regulations or setbacks that could have severe consequences on the business.

Mergers and Acquisitions can disclose major discrepancies in the case of a product line or a business that may diminish its value. These inconsistencies may be associated with incomplete authorization processes, inadequate labelling practices, products that do not comply with the applicable regulations and unresolved compliance issues.

Whether acquiring a product, purchasing drug substances or drug products, or engaging third-party manufacturers for contracted services, a complete exploration, or due diligence, of the target companies or suppliers is crucial. It’s essential to assess their technical capabilities, availability of regulatory documentation, and the reliability of the data they produce.

QACAL  helps provide the single window with experienced hands and subject matter expertise of performing out due diligence to assess.

•  Technical capabilities and regulatory framework of target companies
•  Regulatory manuscripts on Finished Dosage forms & APIs of the target brands or companies

•  Overall regulatory & quality capabilities of API suppliers and contract manufacturers
•  Regulatory compliance of third-party manufacturers within & outside of India

Basics of Regulatory Due Diligence for Product Development

Regulatory affairs due diligence is an important aspect with respect to ensuring that an organization is compliant with industry-specific regulations whilst mitigating potential risks and facilitating business practices and operations that are sustainable. The process of conducting regulatory affairs due diligence constitutes meticulous and thorough examination & review of how well the organization is adhering to the applicable laws, regulations, and standards that governs its operations.

A regulatory affairs due diligence checklist is critical in ensuring the systematic evaluation of multiple components regarding compliance. This checklist may serve as a structured guide which covers critical elements including legal requirements, quality assurance, and strategies for risk mitigation. By scrutinizing these key aspects, pharmaceutical companies can efficiently identify and address any regulatory pitfalls that may potentially affect the business. Several initiatives can benefit from this process, ensuring that regulatory considerations are integrated into strategic decision-making.

The process of regulatory due diligence goes beyond compliance as it significantly contributes towards management of reputation within the industry, financial prudence, and even an organization’s adaptability with respect to dynamic and ever-changing regulatory landscapes. In order to efficiently operate on a global level, it is imperative for pharmaceutical organizations to have a deep and nuanced understanding of the evolving regulatory environments. They should also have a robust due diligence mechanism that helps navigating regulatory complexities. Regulatory due diligence is a proactive strategy that addresses compliance challenges and supports regulatory excellence by aligning pharmaceutical businesses with applicable requirements & standards for long-lasting success.

1. API/DMF

QACAL  provides expert consulting and efficient services for quality Drug Substance…

Overview – API|DMF Services

Drug Master Files (DMFs) contain confidential and detailed information regarding API processes, from manufacturing, to the storage of APIs. A CEP is referenced in Marketing Authorization Application after approval by EDQM; it’s an API dossier submitted to EDQM that gives detail on ingredient properties as well as manufacture details to be considered when approving marketing authorization applications in Europe. ASMF is a submission to FDA & European regulatory agencies across Europe respectively providing confidential detailed information about manufacturing processes used during drug safety substance production at site locations given. This helps to understand ingredients better through data contained therein such as yield calculations.

QACAL  provides expert regulatory consulting and efficient services for quality Drug safety Substance submissions for US, EU, and other countries. This includes Certificate of Suitability (CEP/COS) submission to the European Directorate for the Quality of Medicines & Healthcare (EDQM). QACAL  assists customers for the processes and documentation involved in filing and reviewing the Drug Master File (DMF) or Active Substance Master File (ASMF).

QACAL  Expertise in DMF services for Active Pharmaceutical Ingredients

•  Writing and submission of ASMF, DMF , and CEP modules
•  ASMF, DMF, and CEP Due diligence
•  API Documentation audit
•  Conversion from CTD/Paper to eCTD
•  Module writing for open part and restricted part ASMF/DMF for API, Intermediates as well Semi-finished dosage units.

•  Module 1, 2 and 3 for writing for CEP dossier for Quality Check and API.
•  API CTD compilation then publishing in eCTD as well as Submission
•  Provide assistance in responding to agency queries and to request for more information

Basics of DMF services for Active Pharmaceutical Ingredients

DMF services for Active Pharmaceutical Ingredients (APIs) are crucial for ensuring drug safety. DMFs provide a comprehensive and detailed information repository regarding the manufacturing, processing, and testing of APIs. A DMF helps to streamline the regulatory review process as it facilitates communication between API pharma manufacturers USA and regulatory authorities and ensures that APIs meet the stringent safety and quality standards. This is important for assessing and mitigating potential risks that are associated with drug production.

Indeed, DMF services USA play an integral role in the pharmaceutical industry, particularly in the realm of active pharmaceutical ingredients. Pharmaceutical organizations submit DMFs for their products to provide confidential and detailed information about the manufacturing, quality, and safety of API pharmaceuticals. Regulatory authorities reference DMFs when they review drug applications. By ensuring transparency in API pharma and regulatory compliance, DMF services facilitate a smoother approval pathway by streamlining regulatory processes. Indeed, DMF services support the commitment to regulatory excellence in the API pharmaceutical sector.

1. CMC Advisory

When it comes to regulatory strategies, CMC documentation play a crucial role in developing…

Overview -: CMC Regulatory Advisory Services

When it comes to regulatory strategies, CMC documentation play a crucial role in developing efficient regulatory approaches for pharmaceuticals as well as biological products. CMC regulatory advisory is crucial when the goal is to release data for multiple markets, with minimal or no additional documentation.

QACAL ’s CMC services is dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases -authoring, preparing, reviewing and submitting all necessary documentation. With a decade plus of experience, QACAL ’s CMC services utilizes optimal data generation to maximize the quality filings worldwide.

QACAL ’s Planning Tool is designed to bring quality to the forefront of every product design phase. It ensures that the right tools are in place early, establishing robust quality processes from the very beginning. QACAL ’s knowledge base provides targeted guidance across key areas, from APIs to manufacturing practices, including stability studies, excipient selection, and sterilization techniques. For instance, it offers predictive assessments for sterility, advice on containment systems like closures and vial stoppers, and recommendations for extractable and leachable testing methods. Additionally, it outlines essential standards for each stage of pharmaceutical lifecycle management (PLM), from initial qualification through to post-market surveillance.

Summary of QACAL ’s CMC advisory expertise include:

•  QACAL planning
•  Injectable Packaging – Extractable & Leachable, Sterilization
•  Drug Device Combination products
•  API Selection based on KSM
•  Exhibit Batches

•  Review of CMC documentation for new product registrations, post approval submission and follow-up closely on queries and through approval.
•  CMC section preparation and review (Module 3, Module 2.3 and relevant Module 1 documentation).
•  CMC regulatory intelligence.

Basics of CMC Regulatory Advisory

CMC Regulatory Affairs Consulting is a specialized field that plays an important role with respect to successful development and regulatory approval of pharmaceutical and allied products. CMC focusses on the consistency and quality of the drug substance and drug product throughout all its lifecycle stages. CMC Regulatory Affairs consulting USA is integral for pharmaceutical organizations that need guidance for navigating the intricate and dynamic regulatory landscape. QACAL ’s CMC consultants provide invaluable expertise in developing a robust CMC Regulatory Strategy, ensuring alignment with overall regulatory and development plans. By strategically planning for CMC related aspects, pharmaceutical organizations can significantly enhance the efficiency of their product development programs while streamlining the process of obtaining regulatory approval.

CMC Regulatory Advisory services is crucial especially during the early stages of product development. QACAL ’s CMC consultants collaborate with its clients to conduct a thorough CMC review of the technical documentation, assessing the adequacy and compliance of the documents pertaining to manufacturing processes, controls, and quality. This comprehensive review is necessary for identifying potential issues which could affect the regulatory submissions approvals for pharmaceutical products.

Period CMC Review is conducted throughout the drug development lifecycle to assess any changes that are made to manufacturing processes. This ensures ongoing compliance with regulatory requirements. QACAL ’s CMC consultants play a pivotal role in preparing a submitting regulatory documents such as IND applications, NDAs, and MAAs. Indeed, a well-constructed and robust CMC Regulatory Strategy is a dynamic roadmap that adapts to the ever-changing regulatory environment. CMC Regulatory Affairs Consulting services USA continually assess changes in regulations and industry standards which provides customers with updated and most recent insights to refine and optimize their regulatory strategies.

Pharmaceutical companies around the world can proactively address potential challenges, optimize manufacturing processes, and ensure regulatory compliance by leveraging QACAL ’s CMC Regulatory Advisory services. The collaboration and synergy between pharmaceutical companies and QACAL ’s CMC experts is pivotal in facilitating successful and compliant regulatory submissions, thereby contributing to the timely approval and rapid market access of pharmaceutical and allied products.

1. Post Approval Life Cycle Management

Managing the post-approval life cycle of a product is an essential component to sustaining…

Maximize Product Value with Expert Pharma Lifecycle Management

Ensuring a product’s success after launch depends on effective post-approval lifecycle management, a crucial process for keeping products on shelves and compliant with ever-evolving regulations. This involves maintaining high standards, and meeting stringent requirements of quality, safety, and accurate labelling. Managing the post-approval lifecycle includes handling any administrative, labelling, or quality changes that could affect the production process or labelling standards, impacting regulatory compliance.

For instance, once marketing authorization (MA) is granted, any further changes in production, labelling, or processes that might influence compliance require filing supplements. These applications notify regulatory authorities, allowing them to assess and authorize changes where necessary. The Q12 ICH guideline and EMA’s EC No. 1085/2003 both provide clear frameworks for managing these essential lifecycle updates.

Regulatory services pertaining to Post Approval Life Cycle Management at QACAL  are delivered by a team of highly skilled regulatory and post-approval specialists. We provide our well-established processes for managing post-approval changes whether it is Type 1A, 1B, II, variations as defined by EU regulations or CBE, CBE 30, PAS as required by US FDA.

QACAL ’s post-approval life cycle management services include:

•  Variations pertaining to
•  Labelling Change Notifications/approvals
•  Artwork changes
•  Any Change related to manufacturing process

•  Marketing Authorization Holder (MAH) transfers
•  Certification of Suitability (CEP) updates/new CEPs
•  Monograph updates i.e., Compliance to Pharmacopoeia
•  Shelf-life extension/reduction

1. Regulatory Certification

Administrative documents are an integral component of regulatory submissions and constitute key certifications…

Regulatory Certification Services.

Regulatory Certification of Pharmaceutical Products

Administrative documents are an integral component of regulatory submissions and constitute key certifications. These can include Letter of Authorization (LOA) Certificate of Pharmaceutical Product (CPP), Certificate of Suitability (CEP), Good Manufacturing Practice (GMP) etc. Regulatory services agencies require manufacturers to have these certificates notarized, apostille, and legalized if they wish to enter a new market which guarantees the authenticity and ultimately the quality of the product to expedite market access.

Legalization practices vary across different regions; certain agencies may require document submission to be done online while others require in-person submission. Similarly, depending on the country, a certificate need not be legalized if it has been notarized and apostille. Navigating through such requirements for certificate verification can be challenging for manufacturers that wish to penetrate an unfamiliar market or region.

QACAL has experience in vast majority of developed and emerging markets that require administrative certification to be notarized, apostilled, and legalized for timely submissions. QACAL ’s local representatives liaise with the appropriate Embassy and Chamber of Commerce to get administrative certificates notarized, apostilled, and legalized for timely submission of dossiers. Whether they are regional differences in certificate requirements, translation services, or physical certificate submission, QACAL  covers all aspects of verifying administrative certificates.

Basics of notarization, apostille, and legalization.

Notarization, apostille, and legalization are processes through which administrative documents and certificates are authenticated in order to support regulatory submissions. They differ in scope and purpose, so it is critical to understand the distinctions in order to support the international acceptance of critical documents. Different regulatory authorities may have different requirements with respect to notarization, apostille, and legalization of respective documents & certificates. Harmonizing these processes facilitates the smooth submission and acceptance of regulatory documents. Notarization of certificates is common for national documents but may not be sufficient for international use; apostille of a certificate or document simplifies its acceptance across Member countries reducing the need for further legalization. Legalization of certificates and documents involves the authentication by multiple authorities and is necessary for those countries not recognizing the apostille.

Basics of administrative documents and certificates services for regulatory

Certificate of pharmaceutical product: This is a document issued by regulatory authorities which confirms the safety, efficacy, and quality of a pharmaceutical product. It facilitates international trade and ensures regulatory compliance to expedite the product approval process.

Letter of Authorization: This document grants permission to an entity or individual to act on behalf of another in regulatory matters. A Letter of Authorization is pivotal in delegating responsibilities, facilitating communication, and ensure regulatory compliance in order to foster efficient and effective regulatory operations.

Certificate of Suitability: This document is issued by regulatory authorities to confirm that a pharmaceutical substance complies with the applicable quality standards. A Certificate of Suitability is crucial in order to expedite regulatory approval processes, ensuring product quality, and fostering the acceptance of pharmaceutical substances globally.

Good Manufacturing Practices (GMP) Certificate: This certificate attests that a manufacturing facility complies with safety and quality standards for pharmaceutical production. Obtaining a GMP certificate is critical for demonstrating adherences to industry regulations, ensuring product safety and facilitate trade on a global scale.

1. ANDA and MA Holder Services

The regulatory approval pathway for Abbreviated New Drug Applications (ANDAs) is relatively complex….

Managing Regulatory Compliance for Abbreviated New Drug Applications

The regulatory approval pathway for Abbreviated New Drug Applications (ANDAs) is relatively complex, involving significant investment of money and time. ANDA applicants must ensure they meet the stringent requirements set by the US FDA. Minor mistakes can lead to ‘Refusal to Receive’ (RTR) which can pose a significant cost burden to the company and delay the approval process. Not only must ANDA applicants make sure they maintain regulatory compliance, but they also must ensure their outsourced facilities, including manufacturing sites, are compliant with applicable regulations. Therefore, it is important for ANDA applicants to communicate with the US FDA throughout the entire ANDA filing process for any clarifications- from product development to approval stages. Moreover, foreign companies that are looking to obtain approval from the US FDA must also appoint a US Agent to support them with the ANDA process. US Agents play an important role in facilitating communication between the foreign companies and the US FDA for ANDA filings.

Strategic Partnership for Marketing Authorization Holder Services

In the European Union (EU), companies looking to obtain marketing authorization (MA) from the European Medicines Agency (EMA) for their products must make sure they adhere to EMA’s stringent requirements. MA holders must ensure that they, and other facilities involved in the MA approval process, comply with EU legislations and guidelines. Furthermore, to stay ahead of regulatory hurdles and gain a significant market share within the European Union, pharmaceutical companies are looking to partner with EU local entities, with robust knowledge and experience of the EU market, that can hold the MA on behalf of them. From a business and operational perspective, having a local presence in one EU Member State allows pharmaceutical companies to manage and distribute their products across the entire EU region. It also enables a clear communication channel with EMA and Competent Authorities (CAs) of Member States. This strategic partnership helps to ensure compliance with EU regulations to obtain timely MA approvals and manage product lifecycle throughout the region.

Similarly, the ASEAN region presents global pharmaceutical companies a lucrative opportunity, due to its expanding healthcare and harmonized regulatory processes, to bring their products to the ASEAN market. Global companies are looking for on-ground presence in the form of representative offices in the ASEAN region to support them with MA holding (including registration certificate holding) and carrying out the necessary activities for regulatory compliance. This supports global pharmaceutical companies in further sale of their products into the South-East Asian territories.

QACAL ’s ANDA and MA Holder Services

Given the multiple challenges surrounding ANDA filings and obtaining regulatory approval , pharmaceutical companies prefer to partner with experts that bring technical experience and local infrastructure to support seamless ANDA filings. QACAL  Pharma Inc. in Delaware, USA is verified by the US FDA to carry out abbreviated new drug application (ANDA) services for its customers. Through its local US Agent support, QACAL  can facilitate communication & correspondence with the US FDA, schedule pre-submission meetings, submit citizen petitions, and enable GMP audits/inspections. QACAL  has supported its customers with ANDA services and have held ANDAs on behalf of pharmaceutical companies for ANDA submissions, obtaining timely approvals, and handling post-approval lifecycle management.

In Europe, QACAL Pharma GmbH, in Köln, Germany allows QACAL to provide marketing authorization (MA) holder services to pharmaceutical companies to take on the responsibilities and duties of MAHs for the required time period. The MAH services provided by QACAL  has supported customers who wish to penetrate the European market as non-EU Member States and those that require a GMP-compliant Pharmacovigilance (PV) and quality management system (QMS). QACAL  has also supported pharmaceutical companies looking to obtain MA, particularly through mutual recognition procedure (MRP) and decentralized procedure (DP) through external MAHs, and additional services including Qualified Person for Pharmacovigilance (QPPV).

QACAL ’s Global Presence

Our capabilities include:

•  LTR Services
•  RTR Due Diligence for ANDAs
•  Due diligence of business validation rejection criteria- UK, EU, MOHAP, Saudi FDA, Jordan, Lebanon, Algeria, Morocco, etc.
•  LQPPV Services for ASEAN, GCC, Africa, LatAm, CIS, UK & EU

Basics of Regulatory Affairs Services

Regulatory affairs services in the pharmaceutical industry are associated with ensuring compliance to applicable regulations. It is important to meet the legal standards and requirements to facilitate product approvals in order to bring safe, efficacious, and high-quality pharmaceutical products to the market.

The role of regulatory affairs services in pharma is crucial to manage regulatory compliance. These services ensure the facilitation of drug approvals, liaison with the competent authorities, and adherence to safety & quality standards. Regulatory affairs professionals and organizations play a critical part in navigating the complex regulatory landscape in order to bring pharmaceutical products to target markets while maintaining regulatory compliance.

The regulatory affairs services in usa portfolio is vast and extensive. At QACAL, these include regulatory & strategic advisory consulting, regulatory strategy, submission and publishing management, product registration, quality assurance and compliance, labelling, artwork management, certification services, CMC advisory, API DMF support, gap analysis & remediation, regulatory training, and more.

Regulatory affairs services usa help pharmaceutical companies in launching a new product to the desired market by ensuring they are compliant with regulations- regardless of how complex the regulations are. The services help in developing strategic plans, compile and submit the required documents, liaise with competent authorities, and stay informed of any recent regulatory updates. Regulatory affairs services also help to mitigate compliance & financial risks, expedited product approvals, and maintain lifecycle management.