TOTELL

Regulatory Affairs​

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All emerging therapeutics undergo rigorous government agency evaluations to ensure drug safety and efficacy for patients worldwide. As one of the most critical functions in clinical development, this is an area where you do not want to cut corners or take chances on an outsourced vendor where you have limited oversight when preparing and submitting your documentation to health authorities. 

Our regulatory experts have decades of experience in assembling regulatory packages, writing and submitting technical documents and applications, and representing clients at agency meetings. Many of our consultants are ex-FDA reviewers and know exactly what you must have and what to expect when submitting your therapeutic candidate for approval. Whether you need one professional to oversee the completion of all modules for an NDA or a project team comprising SMEs for the CMC, clinical, and nonclinical modules, we are committed to providing the highest quality of work product while complying with your budget. 

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Our expert medical writers craft clear, precise, and comprehensive documentation that meets regulatory standards. From clinical study reports to regulatory submissions, our professionals deliver high-quality content that enhances your project's success.