BioScience Writers LLC
 

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  • Texas Children's Cancer Center
    "We were extremely pleased with Michelle. She was very pleasant to work with, very organized and greatly improved our application. She was very committed to the project. Personally, I hope we don't have to write another grant without Michelle's assistance!! "
    Krause, Susan
    United States

   
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Regulatory and Compliance Support Services

We offer regulatory agency (FDA, ICH, OECD, and EPA) compliance support during the development of new chemicals, drugs, and/or biologics. This support includes editing services for documents created by our clients and extends to the development of a wide variety of documents needed in the regulatory community, including:

  • Quality Management Plans
  • Quality and Compliance Training Modules
  • Standard Operating Procedures (quality and laboratory procedures)
  • Validation Master Plans and specific validation modules (equipment and analytical procedures)
  • Investigational New Drug Applications or Biologics License
       Applications contributing report and CMC editing

The documents created will support manufacturing, nonclinical tests, and human clinical trials in compliance with current Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices, respectively. Development opportunities will be accomplished in close collaboration with our clients to offer regulatory documents that are complete, concise, and compliant.

Please email or call to learn more about our regulatory compliance services.















Charles L., Regulatory Compliance Consultant