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Regulatory & Compliance

Regulatory Services

  • Rochem’s Regulatory group ensures that all Pharmaceutical, Nutritional, and Food products meet their applicable monograph/standard (USP/NF/EP/FCC) and are always labeled and packaged correctly.
  • Rochem’s Regulatory group has the expertise to file and maintain Drug Master Files and Certificates of Suitability (COS) in virtually any regulated market.
  • Regulatory submissions filed by Rochem are prepared by our U.S. and Qingdao, China based Regulatory teams in coordination with product manufacturers. This ensures the most accurate and technically sound submission possible.
  • All DMF/COS submissions are filed in Common Technical Document (CTD) format. Rochem’s expert regulatory group has the capability of filing electronic DMFs (eCTD) to support the fastest approval possible for our customers.
  • Our close relationships with our represented manufacturers allows us to respond quickly and accurately in all aspects of regulatory submissions.
  • The experience of our Regulatory staff and good working relationship with the FDA, enables Rochem to address Regulatory issues and expedite regulatory approvals quickly.
  • Rochem’s Regulatory group is well versed in the GDUFA law and ensures that all required Rochem represented API suppliers have Self Identified with FDA and Facility Fees paid. In addition, Rochem insures that all submitted Drug Master File fees are paid and that they pass initial FDA review in a timely manner.