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A multifaceted approach enabling seamless integration of formulation characteristics, experimental data, pharmacokinetics, regulatory strategy and mathematical modeling could be the key towards a faster and successful development of newer formulations.
We have accumulated over years, wide expertise with various dosage forms including inhalers, NDDS, topical as well solid and liquid oral dosage forms with regulatory experience across various markets.
Speciality formulation development
Delivery, dose regimen and dosage form selection
Optimization challenges
IVIVC
PKPD
Regulatory strategy and technical assessment
Clinical validation approaches for new product or fixed dose combinations.
Design of experiments
Custom mathematical models and simulation
Proof of concept PKPD and clinical studies.
BA/BE trial designs
Repurposing programs
Complex generics
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