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

FDA Approvals

  • With more than 90 successful inspections over the past 10 years and a 30+ year relationship with the FDA, ChemWerth’s track record of regulatory and compliance excellence is unmatched.
  • 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.

 


Our History of Compliance

2015

  • North China Pharmaceutical Huasheng – September
  • Sichuan Credit-ChemWerth Pharmaceutical Co. – July (Zero 483s)
  • Jiangxi Guoyao Pharmaceutical – May
  • Fujian Kerui Pharmaceutical Company – May
  • Shandong Qilu King-Phar Pharmaceutical – April (Zero 483s)
  • Chengdu Shengnuo BioPharm Co. – April (Zero 483s)
  • Tianjin Pacific Pharmaceutical Co. – April (Zero 483s)
  • Chongqing Daxin Pharmaceutical Co. – January
  • Enoray – January

2014

  • Tianjin Weijie Pharmaceutical Co. – September
  • Zhejiang Ruibang Laboratories – June
  • Xian Libang Pharmaceutical Co. – May
  • Lianyungang Runzhong Pharmaceutical Co. – March (Zero 483s)

2013

  • NCPC – November
  • CPRI – October
  • Qilu General – September (Zero 483s)
  • Huzhou Zhanwang Pharmaceutical Co. – September
  • Enaltec Labs – August (Zero 483s)
  • Chongqing Daxin Pharmaceutical Co. – April (Zero 483s)
  • Jinan Jinda Pharmaceutical Chemistry Co. – March
2012

  • Jiangsu Hengrui Medicine Co. – August (Zero 483s)
  • Sichuan Credit-ChemWerth Pharmaceutical Co. – June (Zero 483s)
  • Chongqing Shenghuaxi Pharmaceutical Co. – June (Zero 483s)
  • Chengdu Shengnuo BioPharm Co. – May (Zero 483s)
  • Jiangsu Hansoh Pharmaceutical Co. – March

2011

  • Jiangxi Guoyao Pharmaceutical Co. – December (Zero 483s)
  • Strem Chemical Co. USA — December
  • Tianjin Pacific Pharmaceutical Co. – September (Zero 483s)
  • Shandong Qilu King-Phar Pharmaceutical Co. – August
  • ChemCon GmbH — July (Zero 483s)
  • Yichang Sanxia Pharmaceutical Co. – June (Zero 483s)
  • ChemWerth Pharmaceutical Technology Co. – June (Zero 483s)
  • Tianjin Weijie Pharmaceutical Co. – April (Zero 483s)
  • Fujian Kerui Pharmaceutical Co. – April
  • Xian Libang Pharmaceutical Co. – January