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Regulatory Services for Clinical Trials



MatrixPharm has the experience and expertise to provide all the regulatory support services required throughout the drug development process. Regulatory support for conducting Clinical Studies includes:

  • A review of the documents provided by the sponsoring company (this service can be provided on a stand-alone basis)
  • Preparation of the full set of documents required to apply to the Russian and/or CIS health authorities and national ethics committee(s) for approval to conduct your clinical study (including a translation from English into Russian)

Registration Services


MatrixPharm offers a full range of registration services to pharmaceutical and biotechnology clients to register drugs, drug substances, biologically active supplements and medical equipment:

  • Strategic regulatory consulting
  • A review of the documents provided by the sponsoring company (this service can be provided on a stand-alone basis)
  • Preparing top-quality regulatory documentation and submissions, expediting all stages of the registration process, general support
  • All services are provided in conformity with the current legislation of the Russian Federation, and in the shortest possible time

 


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