Technology development for complex injectable, ophthalmic, topical and solid oral dosage forms.
Developed several non-infringing processes for drug products with patent filings
Obtained international regulatory accreditations for several pharmaceutical facilities and products.
Submission and approval of several ANDA’s , ANDS and Dossiers for USA, Canada and Europe respectively
Established regulatory strategies by adopting Para IV , 505 (b)2 approach.
Identified business potential for value-added products with strategic plans
Established strong network with key service providers and vendors for business operations and necessary deliverables