Infill Life Sciences Information

Infill Life Sciences LLP is a pharmaceutical service providing company based out of India and providing services in the field of Quality, Regulatory, Formulation & Development, Analytical, Technology Transfer, Vendor Qualifications (API / Excipients), Clinical/Non-Clinical and Toxicological support (Includes PDE Reports, Clinical and Non-Clinical Summaries). We provide services in the field of vendor audits, due diligence, GMP evaluation, Regulatory document preparation for various regulatory agencies such as MAA, ANDA, NDA, addressing the deficiencies, correspondence with the FDA, EU dossier preparation etc. Specifically, with respect Pharmaceutical Regulatory domain we have knowledge, understanding & expertise as required for developing and registering the products with US FDA, MHRA and various other regulatory agencies. Infill team has extensive experience in preparing, reviewing, submitting ANDAs, MAAs in CTD / eCTD formats and getting approval of drug products from various Health Authorities (US FDA, EU and ROW). The team is well experienced in the preparation, review, submission and approval of DMFs (CTD/eCTD formats) from Health Authorities (US FDA, EDQM, EU and ROW) for global markets. The team has prepared meeting requests, packages and had face-to-face meetings (Pre-ANDA, Pre-IND, EOP, and GMP) with US FDA. Also had multiple telephonic meetings with various Health Authorities (US FDA, EMA, and MHRA). The team has experience of supporting formulation development team from Regulatory expectations perspective, evaluating Q1Q2 compliance and doing controlled correspondence with the agency as may be required.