Regulatory Strength

ChemWerth's experienced in-house regulatory group maintains an active channel of communication with both the FDA and the USP committees. We have 16 full-time ChemWerth regulatory employees based in Connecticut and Shanghai conducting audits of our factories twice a year using ChemWerth's FDA Quality Systems program. We do not hire outside consultants because ChemWerth has a vested interest in ensuring that both our API manufacturers and Finished Dosage customers obtain the necessary results to meet FDA – cGMP compliance requirements.

 

Regulatory Services

Key to ChemWerth's success is our full range of regulatory services. Our close association with our represented manufacturers enables us to respond quickly and reliably to all aspects concerning regulatory submissions, cGMP issues, quality assurance issues and technical service requests. Our experience, knowledge, and good working relationship with the FDA help us to expedite regulatory approvals.

Our regulatory department continues to expand in both the US office and the Shanghai office. Our goal remains the same, to provide technical and regulatory expertise to our contract manufacturers and to provide the technical and regulatory support to our customers that help them get the speedy approval needed to maintain a competitive advantage.

 

Successful Track Record

  • Over 200 DMFs, eDMFs, and COS filed in US, EU and its state countries, Canada, Australia, and New Zealand
  • Over 40 first-to-market generic approvals
  • Over 130 FDA Inspections – Over 25 in last 5 years
  • 44% of FDA inspections in the last 5 years passed with no 483 issued.
  • 28 FDA inspected & approved ChemWerth-represented manufacturers located
    in China, Europe, India, and United States
  • 7 ChemWerth-represented factories with FDA approvals on Fermentation products
  • 28 years of successful experience in working with manufacturers in China plus our own R&D and Analytical Laboratory at our Shanghai facility.
  • Within the past six years, ChemWerth has completed in excess of 600 regulatory filings in more than 20 countries.