Regulatory Expertise

Regulatory Compliance

Committed to Stringent Regulatory Compliance You Can Trust

Our goal is to exceed all regulatory and compliance guidelines to ensure our customers receive only the finest ingredients.  We train and audit our partners to ensure FDA-compliant Current Good Manufacturing Practices (cGMPs) in all of their technologies and systems.

Internal Compliance

Rochem’s internal global operations are fully cGMP compliant according to requirements set forth in ICH Q7 “GMP Guide for Active Pharmaceutical Ingredients” for pharmaceutical distributors as well as IPEC and USP “Good Distribution Practices”. This internal cGMP control includes the following:

  • Our global operations are completely controlled by internal Standard Operating Procedures and quality systems that include control of logistics, warehousing/material handling, and all regulatory/compliance/quality activities.
  • Logistics procedures are maintained to ensure complete traceability of all distributed material.
  • Customer change communication and quality complaint handling systems are in place.
  • Quality agreements are in place with all Rochem-represented manufacturers.
  • Rochem has been FDA inspected as well as audited by several multinational organizations for cGMP 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 guaranteed to be labeled and packaged correctly.

  • Rochem’s Regulatory group files and maintains Drug Master Files (DMF) and Certificates of Suitability (COS) in virtually any regulated market.
  • Regulatory submissions filed by Rochem are prepared by our regulatory teams in both U.S. and Qingdao, China in coordination with product manufacturers.
  • Rochem’s expert regulatory group files electronic DMFs (eCTD) to support the fastest approval possible for our customers.
  • Our experienced regulatory staff fosters excellent working relationships with the FDA allowing Rochem to address Regulatory issues and expedite approvals quickly.
  • Rochem’s Regulatory group is well versed in GDUFA law and ensures that all required Rochem-represented API suppliers have self-identified with the FDA.

Technical Support

Rochem offers technical support to our customers as well as our represented manufacturers, including, but are not limited to, the following:

  • Full project management from product conception to commercialization
  • Creation of sound technical packages
  • Manufacturing process and product quality optimization
  • Analytical support and problem solving
  • Establishment of manufacturer product specifications
  • Customer complaint investigations