Product Research & Development Service
Our R&D infrastructure is partnered with the sophisticated team with a facility located in Hyderabad, India. The major operation focus on China healthcare industry through integrated finished pharmaceutical product development to product launch into China market and further provide to our clients and global healthcare needs.
Our service supports the customer in the finished pharmaceutical development & product launch by means of:
- Literature search / IP clearance
- API analysis / selection
- Excipients and packing material selection
- Prototype formulation development
- Formulation process optimization & Compatibility studies
- Development in Quality-by-Design style
- Packaging development
- Equivalence of RLD and in-house including exploratory R&D stability
- Sale-up demonstration at the customer site
- Process validation / Exhibit (for registration purpose) batches
- Stability studies on process validation batches both accelerated as well as real-time
- In-vitro & In-vivo (on In house formulae vis-à-vis with RLD/innovator).
- Dossier submission support in electronic eCTD / CTD
- Product launch support
KEY R&D AREA
The competence of the scientific staff comprises concurrent as well as advanced technologies which includes but not limited to:
- Complex formulation development in therapeutic segments like Oncology, Diabetology, steroids, hormonal products, NSAID, Psoriasis etc
- Capable of developing instant release, extended release, bi-layer, combination products
- Capable in developing simple liquid preparations, lyophilized products to non-aqueous based as well as complex emulsion preparations
- Capable to develop NCE products, NCE-1 products and generics