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Sharon 's API research team constantly seeks development of non-infringing routes for APIs in therapeutic segments like cardiovascular diseases & anti-ulcerants In order to aid our customer's regulatory filing efforts we can provide the following documentation. We undertake exclusive manufacturing services for your APIs and intermediates without compromising our customer's intellectual property.
- Test Method Reports
- Analytical Method Validation reports
- Stability Reports
- Audit Reports for Labs, Manufacturing facilities and Raw Material suppliers
- Certificates of Analysis
- Specifications
Sharon 's strength lies in its state-of-the-art manufacturing facilities for finished dosage forms, viz. Tablets & Capsules and Injectables. Sharon has identified niche areas of Oncology for the export markets.
Sharon's Regulatory Affairs Department caters to compilation and submission of registration dossiers to various countries. The department comprises of a team of highly qualified professionals updated with respect to current regulatory guidelines of various countries we cater to. For regulated markets, Sharon also undertakes contracts for ANDAs & CTD Dossier Development according to customers needs.
Through our SA-FORD division , we offer long term Toxicological Studies on Rodents. SA-FORD works as per internetional regulations (OECD GLP, EPA, ICH, ISO 10993 and others). Due to its highest standards in all aspects, SA-FORD will be one of the leading toxicology laboratories in India. Our Team is a combination of Indian & German staff follows international regulation. |