Certification & Accreditation

The Custom Healthcare certification and accreditation ensures practices are acceptable, typically meaning that they are competent to test and certify third parties, behave ethically, and employ suitable quality assurance.

One example of accreditation is the accreditation of our testing laboratories and certification specialists that are permitted to issue official certificates of compliance with established standards, such as physical, chemical, forensic, quality, and security standards.

The Custom Healthcare Group accreditation and certification of competency, authority, and credibility currently includes:

IMP License

MHRA Approval

Home Office License

Specials License

Investors in People

Our experienced team of Regulatory affairs professionals can assist you with all your regulatory needs including:

  • Regulatory project management / strategy advice

  • Marketing Authorisation Applications

  • Variations

  • DMF review and submissions

  • Regulatory Due Diligence evaluation

  • PIL user testing

If you are based outside the EU, we can help you enter the market by:

  • Preparing and submitting dossiers to meet EU requirements
  • Updating and submitting existing dossiers to meet EU specification
  • Compiling and submitting licence variations

 Click here for details of our Analytical Services

 

IF YOU HAVE A PROJECT ENQUIRY, PLEASE CONTACT OUR CUSTOMER SERVICES TEAM USING THE ENQUIRY FORM BELOW

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