We have a complete portfolio of regulatory affairs and medical affairs services to support the successful development and timely registration of human and veterinary medicines including originators, generics, and biotech products.
With a strong track record for delivering excellent results in regulatory affairs to our clients, we focus on completing tasks with high quality in a timely and cost efficient manner. We handle
- National Procedures (NP)
- Mutual Recognition Procedures (MRP)
- Decentralized Procedures (DCP)
- Centralized Procedures (CP)
- NDAs and ANDAs
This also includes preparation of product information for initiation of the EU and US procedures, responding to deficiency letters from RMS/CMSs and the FDA during the procedures in tabular format, and updating the texts, accordingly.
Post approval activities and life cycle management support comprise services such as variations and work sharing procedures in the EU, amendments/supplements in the US, renewals, MA transfers, and withdrawals.
For more information, please contact RA Operations Team.