The REGULATORY AFFAIRS Company™
A comprehensive approach to consulting
The REGULATORY AFFAIRS Company™ is a global regulatory consultancy for pharmaceutical and device companies. We have extensive experience across a spectrum of product types, having a proven track record in assisting companies to meet their legislative requirements and having a 100% success rate with clinical trial submissions.
The REGULATORY AFFAIRS Company™ uses its processes to facilitate commercial efficiency and cost-effectiveness in helping to bring clients’ development plans to reality and products to market.
The REGULATORY AFFAIRS Company™ offers the advantage of comprehensive client-side experience to companies seeking to challenge over-cautious approval strategies which are sometimes an indicator of inadequate broad spectrum Regulatory Affairs experience.
Our Services
The Regulatory Affairs Company™ provides a range of offerings to clients covering medical product Regulatory Affairs and Medical Writing Services.
The team’s expertise covers:
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Regulatory Consultancy
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Country-specific strategic planning (preclinical through post-marketing)
Medical Writing is a fundamental part of clinical research. The Regulatory Affairs Company™’s Medical Writers work closely with TCTC colleagues in the Full Service, CRA, CQA and DM divisions of TCTC to deliver compliant, practical, timely and cost-effective documents to the required ethical and scientific regulatory standards.
The Regulatory Affairs Company™’s Medical Writers integrate with each client’s team by being flexible to their specific requirements and using TCTC experience and expertise to ensure quality outputs from every trial and investigation. TCTC have a breadth of knowledge and experience drawn from the pharmaceutical and medical device industries as well as healthcare providers and academia. All documents produced by TCTC undergo thorough scientific, statistical, editorial and quality control review to ensure expedited regulatory review wherever possible.
The Regulatory Affairs Company™’s Medical Writing services include regulatory and clinical writing, as well as manuscripts for publication, educational material and Medical Writing consultancy.
Examples include:
