Our Services
At WINSIA, we believe in partnering with our clients to turn great ideas into successful products. Whether you’re working on generic drugs or looking to develop differentiated formulations, our experienced team is here to guide you every step of the way.
Whether it is product profiling, differentiated product identification, market strategy and intellectual property management, formulation development, regulatory support, analytical method development, or quality control and quality assurance services, WINSIA is committed to offering smart, efficient, and reliable solutions for your development needs.
WINSIA Life Sciences provides services from start to end for successful product development and launch. We offer consulting services for the below:
Product Profiling and Strategy Management
- We have the expertise to carry out relevant literature research including patents and non-patent literature (research articles, preclinical studies and clinical studies) to identify the lead product for development.
- We have the expertise to conduct market search and competitor product study (Products available in global and domestic markets) to identify the niche products.
- We have the exp• WINSIA can help client to identify potential products and suggest strategies for market entry.ertise to conduct market search and competitor product study (Products available in global and domestic markets) to identify the niche products.
Intellectual Property Management
- Expertise to perform preliminary prior art searches, patent landscaping, identifying white space, freedom to operate.
- WINSIA can undertake QA audits for clients and offers services to handle other QA and QC aspects (SOP preparations, QMS designing, training).
- WINSIA can help client in developing patentable formulations and extend support in filing activities (Provisional specifications, Complete Specifications, PCT applications etc.)
- WINSIA has expertise to advise client on pharmaceutical and nutraceutical product development for regulated, ROW and domestic (India) market. We have the expertise and understanding for regulated and ROW market needs and we can guide our clients to develop the products as per the regulatory requirements of the specific country.
- WINSIA can guide the clients to developed generic (as innovator/ reference bench mark product) as well as differentiated products for clients.
- WINSIA can assist the client in providing Gap analysis and reformulation of its existing products (already in market) to meet the market needs. WINSIA can provide technical package and assist the team for development of these products.
- WINSIA can identify the niche nutraceutical products, develop it and provide the finished product to the client at a fixed transfer price.
Formulation Development
- We can also help our clients in identifying the right vendors for API (Active Pharmaceutical Ingredients), ingredients in nutraceutical products viz. standardized extracts, amino acids, vitamins, niche ingredients etc., excipients and packaging materials. We assist the clients in identifying the right vendor by reviewing the COAs, technical documentations, DMF (Drug Master File) for the material.
- We have expertise to develop various dosage forms targeting routes of administration including oral (tablets, bilayer tablets, hard gelatin capsules, soft gel capsules, powders, liquids), injectables (solution, suspension and emulsion), ophthalmic and other topical routes (gels, ointments, lotions, solutions etc.). WINSIA has expertise to handle niche technologies like taste masking, lyophilization, dual release systems, sustained release systems, 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, Analytical testing laboratories.
Project Management
- WINSIA helps clients in planning and overseeing projects ensuring timely delivery.
- WINSIA ensures successful planning, execution, and closure of a project through resource management and communication.
Analytical 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 (QC) and Quality Assurance (QA)
- 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.
Regulatory Affairs (RA)
- WINSIA offerWINSIA offers regulatory services relating to regulatory filings, dossier preparation for pharmaceutical and nutraceutical products.s assistance in analytical method development and validation for selected products.
- Collaboration with experts having 15 years’ experience in regulatory affairs (Regulated market, ROW, Domestic market).
