Services
Formulation Development
- WINSIA has successfully developed generic as well as differentiated [505 (b) (2)] products for clients.
- WINSIA has expertise to advise client on product development for regulated as well as ROW market.
- We have explored various routes of administrations of drugs including oral, injectable, ophthalmic and other topical routes.
- WINSIA has expertise to handle niche technologies like taste masking, lyophilization, extended release systems, osmotic delivery systems, hot melt extrusion systems and effervescent systems.
- WINSIA has experience in dealing with potent molecules including narrow therapeutic index drugs, hormones, oncology drugs and steroids.
- We have collaborations with Educational institutes, Contract Research Organizations and Contract Manufacturing Organizations to ensure easy operations and timely delivery of the projects.
We also offer following services
Regulatory Affairs
WINSIA offers regulatory services relating to regulatory filings, Dossier preparations.
Collaboration with experts having 15 years experience in regulatory affairs (Regulated market, ROW, Domestic market)
Collaboration with experts having 15 years experience in regulatory affairs (Regulated market, ROW, Domestic market)
Project Management
WINSIA helps clients in planning and overseeing projects ensuring timely delivery.
Analytical Method Development
WINSIA offers assistance in analytical method development and validation for selected products.
Collaboration with experts having 25 years’ experience in analytical development and validation.
Quality Control and Quality Assurance
WINSIA can undertake QA audits for clients and offers services to handle other QA and QC aspects (SOP preparations, QMS designing, training)
Collaboration with experts having 25 years experience in QA
Collaboration with experts having 25 years experience in QA
Intellectual Property and Strategy Management
- WINSIA can help client to identify potential products and suggest strategies for market entry.
Expertise to perform preliminary prior art searches, patent landscaping, identifying white space, freedom to operate.
WINSIA can help client in developing patentable formulations and extend support in filing activities (Provisional specifications, Complete Specifications, PCT applications etc.)
