Clear, concise regulatory documentation is critical to the success of any drug development program. Our highly qualified team of writers include PhDs, PharmDs, and MDs who cover all stages of the drug development process.
Hear from one of our clients:
“Your last comments and amendments are very valuable and virtually all of them have been implemented. Your team really did a great job in helping us to get the modules ready for submission. They look very clean and consistent now.” – Director, In Vivo Pharmacology, Toxicology & DMPK at a biopharmaceutical company in the EU
Proven track record of success in regulatory process and medical writing
We provide services to author clinical, CMC, and nonclinical documents required throughout the full drug development lifecycle, including:
- Investigator brochures and updates
- Clinical trial protocols and amendments
- Clinical study reports
- Briefing documents, meeting requests, and Requests for Information
- All CTD Module 1, 2, 3, 4, 5 components for Initial New Drug Applications (INDs), Marketing Authorization Applications (MAAs), and New Drug Applications (NDAs) to name a few
- Pediatric study plans/pediatric investigational plans
- Patient Narratives and Safety Reporting
- Annual Reports/DSURs/PBRERs
- Clinical evaluation reports (CERs)
- Summaries of Clinical Trial Results for Laypersons (Plain language summaries), Informed Consents/Assents, and clinical trial synopses for laypersons
Are your documents ready for submission to major global agencies?
Your drug development program has overcome many challenges and required a substantial investment to get to this point. Now your submission documents require medical writing expertise across the full drug development lifecycle. Certara provides expert consulting services for regulatory submissions from early-stage INDs, NDAs, and MAAs require CMC, nonclinical and clinical expertise. Most importantly, your submission programs require the coordinated technology-enabled expertise that Certara Regulatory Writing offers.
Certara regulatory writers partner to provide deep technical and therapeutic expertise across all submission document types to create and deliver successful submission documents on time, every time.
Regulatory writing services to expedite your submissions
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) provide support to the world’s largest pharmaceutical companies. Industry best-in-class SOPs drive quality while dedicated QC functions and integrated writing teams reduce reviewer comments and speed time to completion.
As key opinion leaders, Certara’s medical and regulatory writers speak regularly at major industry events such as DIA Annual, AMWA’s Medical Writing and Communication Conference and EMWA’s Medical Writing Conference.
Regulatory Writer Acceleration Residency (RWAR)
RWAR is a unique opportunity for those interested in becoming a regulatory writer. Learn from a team with a proven track record of success in various disciplines of regulatory writing.
During the residency, colleagues will embark on a two-year curriculum, which will teach the skills needed to lead regulatory writing projects while increasing exposure to documents that drive drug development. As a services organization, Certara program offers the opportunity to develop skills necessary to work directly with our sponsors within the initial year of employment. Opportunities exist in the clinical, nonclinical, and pharmacovigilance disciplines.
The ideal candidates will have the opportunity to participate in a mentor-driven training program that accelerates the transition to leading the writing efforts for regulatory documents.