Area Of Expertise

Skill sets

We comprise of team with the right attitude, flexibility, reliability and commitment for excellence.
Our experience of multidisciplinary research working suggests certain ingredients facilitate effective collaborative approach. We have ability to observe and act on technical front and acquire understanding of allied fields.

We are well experienced in managing development program of varied size and complexity in different therapeutic areas like Infectious Diseases, Oncology, Cardiology, Gastroenterology, Nephrology, Diabetes, Urology, Pain Management, Neurology, Psychiatry and many others.

We have experience in executing many ANDAs and dossiers of products. We have development and execution level experience in most of key markets like USA, EU, JP, Brazil China, RCIS, India and Rest of the world (ROW).
We have collective experience of more than 250 global filings. We have capability to connect dots for global requirement.
We are capable to create strategic path in a form and manner that suits the diverse regulatory requirements of multiple markets.

Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality.
Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.
Applying Quality by Design (QbD) in the development of drugs mitigates risks. We believe in KYP “Know your Product” before we think for design space.

New dosage forms, fixed drug combinations and new indications are the most exploited differentiation strategies.
We got good exposure in understanding patient unmet need in few therapeutic areas. This is key step in product differentiation. We have got expertise devising regulatory and clinical strategies for defining differentiated product success.
We have multiple differentiated products developed and approved in various countries. We have capability to acquire understanding of allied fields related to product differentiation.

We are expertise in developing bioequivalent strategies for ensuring desired pharmacokinetic response in dosage form design through identification of suitable IVIVC and bio-relevant media.

We have scientific expertise which can help you build a customized portfolio of solutions including analytical characterization, kinetic capabilities

We strategically help our partners in running parallel program of API development and formulation development. We identify and customize key focus areas in integrated development.
This helps in working multiple strategies for API (For polymorph, Alternate salt, PSD etc), which ultimately helps to connect dots between API and formulation team. This gives faster solutions for day to today problems.