1. Stability Studies for Zone 4 Countries

​

• Stability testing evaluates how environmental factors such as temperature, humidity, and light affect drug quality over time.

• Determines the re-test period for drug substances and shelf-life for drug products.

• Conducted under rigorous conditions to ensure compliance with international regulations.

​

2. Bioavailability (BA) & Bioequivalence (BE) Studies

​

• Bioavailability (BA): Measures the rate and extent of drug absorption into the systemic circulation.

• Bioequivalence (BE): Assesses whether two pharmaceutical products have comparable bioavailability and pharmacokinetic properties.

• In vivo BA/BE studies are conducted to evaluate pharmacokinetic parameters such as absorption, metabolism, and elimination.

• Essential for establishing therapeutic equivalence of generic drugs and formulation changes.

• Conducted through well-designed cross-over studies on healthy volunteers.

• Complies with global regulatory standards to ensure reliable and reproducible results.

​

3. Dossier Preparation Services

​

• Comprehensive dossier compilation for pharmaceutical product registration in global markets.

• Includes administrative, quality, non-clinical, and clinical documentation.

• Expertly prepared in compliance with international regulatory requirements.