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Scientific : Products : Thomson Pharmaceutical Services: Pharmaceutical Consultancy
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Thomson Pharmaceutical Services: Pharmaceutical Consultancy
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We can help you navigate the regulatory hurdles associated with new drug development and to facilitate approval of submissions by international regulatory authorities.
Our Regulatory Affairs Certified (RAC) specialists have extensive experience with the United States FDA, EMEA and Health Canada. We work with you to achieve the objectives set forth by the International Conference on Harmonization (ICH) to increase global harmonization of technical requirements and to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost-effective manner.
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- Guidance in developing regulatory strategies and identifying options
- Liaising with regulatory authorities
- Preparing for and participating in FDA-sponsor meetings
- Serving as US agent for non-US sponsors
- Designing preclinical and clinical development programs
- Planning for key regulatory documents including:
- Investigator Brochures
- FDA Information Packages (briefing documents)
- Expert reports/ white papers |
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