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Global Consulting & Regulatory Compliance

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About Global Consulting & Regulatory Compliance

As a full-service global contract research organization, we provide consulting on a variety of topics, including regulatory compliance. We are closely connected with international regulatory agencies, so your testing and studies can be compliant and meet submission requirements. 

Our regulatory experience spans all development phases for drug and medical device development as well as crop protection and chemical testing. Our team advances your regulatory filings in more than 55 countries while operating from the following countries:

  • Americas: US, Canada, Argentina, Brazil, Chile, Colombia, Mexico and Peru
  • Europe: Spain, Poland, France, Germany, Russia and the United Kingdom
  • Asia-Pacific: China, Singapore, Japan, Taiwan and South Korea

Regulatory Agency Consulting

 

America Agencies

  • FDA 
  • EPA & FIFRA
  • Health Canada (Canada)

Europe Agencies

  • EMA & EMEA (EU)
  • ECHA (EU)
  • CLP (EU)
  • MHRA (UK)

Asia-Pacific Agencies

  • PMDA & MHLW (Japan)
  • NMPA/CFDA (China)

Product Testing Regulations & Consulting

Class I, II & III device & IVDs 

  • EU: EMA's MDR & IVDR
    • Notified bodies 
    • CE Mark
    • U.K. Authorized representative or Responsible Person (UKRP) 
  • U.S.: FDA's Device & IVDs
    • PMA & 510k
    • IDE, CFR, & IRB
  • China: NMPA/CFDA's Regulations on Supervisory Management of Medical Devices 
  • International: ISO 14155

Agrochemical & crop protection regulations

  • Japan: Agricultural Chemicals Control Act 
  • U.S.: Federal Food, Drug, and Cosmetic Act (FFDCA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) & Food Quality Protection Act and the Pesticide Registration Improvement Act (PIRA). 
  • International: Organization for Economic Co-operation and Development (OECD)

Industrial chemical regulations

  • EU: REACH & the European Chemicals Agency (ECHA)
  • UK: REACH 
  • South Korea: K-REACH 
  • U.S.: Toxic Substances Control Act (TSCA) 
  • Canada: Canadian Environmental Protection Act (CEPA)
  • China: MEP Order 7
  • Japan: Chemical Substance Control Law

Milestone & Phase Consulting

IND/CTA Milestone 

  • IND/NDA-enabling programs
  • Early phase development solutions
  • MarketPlace 

NDA/BLA Milestone  

  • Clinical QA & compliance
  • Clinical regulatory strategy
  • Clinical regulatory writing (protocols, CSRs)
  • Clinical submission services 

Post-Market Compliance  

  • Patient-reported outcomes (PROs)
  • RWE studies, prospective observational studies & retrospective data anlaysis
  • Conditional approval 

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