GMP Manufacturing	Agence française de sécurité sanitaire des produits de santé Certificate n° : 2006/HMP/FR0066 Click here

From gram to tens of kilogram scale North American (US) plant registered and inspected by the US FDA, Korean FDA, and approved by Japan's Ministry of Health, Labor and Welfare. European (France) site inspected for GMP compliance by the French Health Products Safety Agency (AFSSAPS) in accordance with Directive 2001/83/EC. Quality Assurance and Regulations The manufacture of GMP grade peptides at NeoMPS conforms to ICH Q7A Good Manufacturing Practices for APIs, -CFR Part 210, 211 & 820 and EudraLex Volume 4, Part II. Facilities in Europe and North America GMP grade peptides can be manufactured in either facility: San Diego, California or Strasbourg, France. The flexibility of the production site can be of great advantage for our customers, depending on the location of their clinical trials and regulatory filings. Furthermore, two facilities assure our clients stability in production. Experience with GMP peptides in clinical trials, Phase I-III and commercial application NeoMPS, Inc. has been manufacturing GMP grade peptides since 1990 and has successfully undergone several FDA inspections. NeoMPS SA opened its GMP production facility in 1998 and was inspected and approved by the French Health Products Safety Agency (AFSSAPS). Nearly 400 GMP peptides - APIs, Medical Device Components, Diagnostic Components - have been prepared to date with several approved for commercial applications. Production capacity is gram to multi-kilogram quantities per batch. Full regulatory support NeoMPS provides complete assistance during drug development:  stability studies of the active ingredient and/or the clinical trial material; assistance with formulation development; support with regulatory filings either in the form of a technical report (CTD format) which serves as the CMC section of the IND or complete preparation and maintenance of a DMF. Production capacities pilot-GMP at NeoMPS SA - 4 independent production units: capacity in solid phase up to 60 Liters chemistry in solution: from 20 to 200 Liters. - 2 independent purification/intermediate lyophilization units (columns up to 110 mm in diameter). - 2 lyophilization units for the reconstitution of the final batches: up to 2/3 kg per batch PURIFICATION AND LYOPHILIZATION IN CLEAN ROOMS, EQUIVALENT TO CLASS 100.000, 10.000, 100.