Food Safety (HACCP – Hazard Analysis Critical Control Point)
“QA CAL offers an exclusive mix of competences in the food safety consultation arena.

We provide expert advice and scientific consultation to stakeholders You can choose QA CAL as the preferred partner to execute Bio equivalence studies of different formulations and be assured of quality, speed and economy. Our BA-BE centre is approved by USFDA/MHRA/EU/PICS/GCC.

1. We provide proof of concept to global submissions in an ethical, efficient and regulatory compliant manner.

2. QA CAL offers specialized solutions in pharmacokinetic and statistical analysis

3. Regulatory support including e-CTD compliant dossier submissions and resolving regulatory queries

4. Competency in handling complex clinical trial designs (hormones, endogenous substances, elemental formulations and locally administered products) besides oral solids/liquid dosage forms.

5. We strictly comply to current GCP/GLP guidelines.

6. Our team is competent in handling different analytical challenges including pro-drug analysis, parent–metabolites simultaneous assays, chiral analysis, elemental analysis, hormones and endogenous substances.

7. State-of-the-art Bioequivalence Facility with well-equipped pathology laboratory.

8. Healthy adult male and female volunteers including post-menopausal women.

9. More than 200 methods developed and validated from various biological matrices like blood, plasma, serum etc.