Development of NDDS (Novel Drug Delivery System).
Development of non infringing process.
New process development for cost effectiveness.
Trouble shooting in the various plants .
Performance batches.
Bioequivalence and bioavailability as per DCGI (Drug Controller General of India) and International guidelines.
Drug regulatory affair and documentation: Dossiers for ANDA’s( Abbreviated New Drug Application) of different countries, NDA's (New Drug Application) filing in India, patents filing after a thorough scrutiny by attorneys, documentation for getting USFDA, documentation for R & D products, documentation for commercial samples, documentation for bioequivalence samples.
Contract Research from conceptualization till the final dossier of the product.
