Pharmaceutical: Proven expertise in development of different dosage forms and delivery systems for global markets: Solid orals (IR, DR, ER, Osmotic, Pellets , MUPS, ODT & ODF), Liquid orals (Solutions, suspensions, PFS) ,Topicals (Dermal, Nasal, Ophthalmic & Otic), Transdermal & Parenterals.
Intellectual property: Good Understanding on IP aspects. Successful filings of "First to File", NCE-1 and Para IV products for US & non-infringing strategies for EU, CA and other global markets.
Regulatory: Well versed with requirements of Global Agencies & expertise to define filing strategies, dossier diligence, eCTD compilation, address regulatory queries and market extensions.
Analytical: Strong Hands on experience of development & validation of various methods to test & establish the quality of wide range of dosage forms.
Clinical: Successfully designed and executed BE studies for BCS IV, highly variable, potent drugs. Experience in In-vitro BE studies for Topicals & skin blanching studies.
Business Development: Our BD and Regulatory office in Toronto, Canada helps easy access to North American and Global Partners.
We help our partners achieve their strategic business goals
