Compliance and Regulatory Support

The key foundation of ChemWerth’s success is our full range of regulatory and compliance services.  Our Regulatory team manages documentation creation, review and submission while our Compliance group manages our Factory Compliance Programs, CMO management and facility inspections.

Factory Compliance Programs

ChemWerth’s Factory Compliance Programs are in place to ensure compliance is maintained in our CMOs.  We do this by educating our manufacturing partners on the “how’s and whys” of FDA requirements and the importance of data integrity.   These programs include:

  • Six System +1 Factory Audit – designed to mirror the FDA inspection process, ChemWerth further customized the FDAs template to include an on-site follow up and training component so the Corrective Action Preventative Action plan is properly implemented.
  • Three Phase Factory Evaluation – in place to ensure our CMOs have the proper systems in place, ChemWerth assesses the internal audit processes and provides feedback and training to explain and correct any identified deficiencies.
  • cGMP Seminar Series – an annual event in which ChemWerth invites all of our manufacturers to a 2 day conference to discuss topics related to cGMP.  Participants complete the seminar with a better understanding of quality and compliance requirements.

Regulatory Filings

  • Over 200 DMFs, eDMFs, and COS filed in the United States, Europe, Canada, Australia, Japan, Korea, and New Zealand.
  • Over 45 first-to-market generic approvals.
  • Since 2010, ChemWerth has completed in excess of 500 regulatory filings in more than 20 countries.
  • Ranked #1 in DMFs Available for Reference when compared to API Companies worldwide.
  • Number of DMFs for reference (65).

FDA Approvals

  • With more than 120 successful inspections over the past 15 years and a 40+ year relationship with the FDA, ChemWerth’s track record of regulatory and compliance excellence is unmatched.
    • Over 200 Customer Audits passed in the last 5 years
  • Starting with careful factory selection, we develop a hands-on approach with our partner manufacturers; performing routine audits, quality checks, compliance reviews and feedback that ensures high-quality pharmaceutical grade API is consistently manufactured.
  • Our factories meet ICH Guidelines, are WHO compliant, cGMP qualified and USFDA approved making sure your Finished Dosage is compliant, effective and meets regulatory criteria in markets worldwide.