Contract Manufacturing & Contract Research
OPES poses wide experience and expertise in regulatory guidelines and manufacturing requirements for varied markets. OPES excel in supporting marketing companies to identify suitable sources and streamline activities related to contract manufacturing & contract research and help them to focus on their key strength of marketing in their respective market.
- Identification of quality compliant and cost competitive manufacturing and/or product development source.
- Ensure GMP (EUGMP/USFDA/PICS/WHO), GLP and other regulatory compliances as per customer need.
- For existing product, streamline complete site transfer activity ensuring time saving and least number of variations.
- Complete dossier, documentation and sample generation as per FDA requirement.
- Dossier or documentation filing by the customer at their FDA. Support during registration or variation filling for responding to FDA queries.
- Packaging material designing.
- Product manufacturing and shipment (After FDA approval).
- Easy and immediate access to Indian, Chinese and European companies’ wide resources of finished formulation.
- OPES have tie up with more than 20 (EUGMP/PICS approved) manufacturing and development facilities in Asia and couple in Europe were OPES enjoys partnerships for developing and manufacturing finished formulations under customers brand name.
- Readily available list of ACTD/EUCTD dossiers from contract manufacturer for therapies like Oncology, Small Volume & Large Volume Injectables, Eye/ Ear Drops, Solid Orals, Semi-Solid formulations in various therapies.
- Products of different categories under one roof complying to required standards of Europe and other PICS countries in addition to WHO.
- Immediate access to cost competitive and quality compliant source.
- You can focus on your key strength i.e. marketing in your territory.
- Shorter lead time for dossier preparation and commercial shipment.