Proven expertise in pharmaceutical development of different dosage forms and delivery systems for global markets: Modified Release Solid orals, Pellets, Oral liquids, Osmotic Systems, Topicals (Semi solids), Transdermal & Parenteral dosage forms.
Good understanding of IP (Intellectual Property) landscape. 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 expertise to define filing strategies, dossier diligence and compilations, regulatory queries and market extensions.
Successfully designed and executed BE studies for BCS IV, highly variable, potent drugs and experience in skin blanching studies.
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
