Regulatory Writing


Booth: 200

Our highly qualified team of writers include PhDs, MDs, PharmDs, scientists and nurses with backgrounds across all functional areas (Document Quality, CMC, Nonclinical, Clinical, and Regulatory). Industry best-in-class SOPs drive quality while dedicated QC functions and integrated writing teams reduce reviewer comments and speed time to completion. Our writers have authored over 200 CMC, 350 nonclinical, and nearly 5,000 clinical documents for sponsors over the past 5 years.

Other product: Transparency & Disclosure

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