ReClin Pharma Services

Navigating the intricate landscape of drug product registration demands meticulous preparation and adherence to regulatory standards. At RPS, we offer comprehensive services tailored to expedite the registration process and facilitate market approval for pharmaceutical products. ReClin Pharma Services (RPS) is instituted by experienced pharmaceutical professionals, who have deep insight and understanding of various stages of drug development including clinical development. We can support you from early strategic planning to post approval activities of pharmaceuticals. Our experts use technology based solutions to support you through the entire drug product life cycle. Key Services: Regulatory Affairs: Pre and Post Authorisation Services include: Consultancy at various stages of drug development. CMC Services - Review of drug substance and drug product data as per regulatory standards. Scientific, Regulatory and Technical Writing. Compilation of regulatory dossier in eCTD and non-eCTD format. Final Submission of dossier to various regulatory agencies. Deficiency Responses to regulatory authority. Compilation and submission of documents for Post-Approval Changes or variations for retaining valid marketing authorisation. Translation of contents of various regulatory documents to and from languages like English, Russian, Japanese, Chinese, Dutch, French, Portuguese, and German etc. (Europe & ROW Markets) Regulatory support for Asean Index & BTIF preparation Impurity Supply: Providing high quality certified impurity standards, working standards, API Related Compound in custom pack size. Providing complete set of data HNMR, 13CNMR, Mass, HPLC, IR, TGA, COA along with products. Provide technical and analytical support to clients. Customise synthesis of product or impurities on request. Translation of documents in all Global Languages etc. Preparation of Toxicology Reports (ADE/PDE Calculation) etc.