Certara’s regulatory writing services provide exceptional expertise across the entire drug development lifecycle. With a team of qualified professionals, including PhDs, MDs, nurses, and PharmDs, we deliver clear, concise, and impactful regulatory documents tailored to your specific program needs. Our services ensure your submissions meet global agency standards, minimizing delays and optimizing time to completion.
Regulatory Writing Services
Delivering high-quality regulatory writing services
Certara’s regulatory writing services ensure expertly crafted, compliant, and timely submission documents to support your drug development goals.
Learn more about Regulatory Writing services
Comprehensive regulatory writing
for timely submissions
Document quality and management
We ensure accuracy, compliance, and efficiency in your regulatory submissions with our quality and management services.
Timely and reliable submissions
We deliver on-time, compliant documents to keep your drug development program on track.
Global regulatory expertise
Our writers are experienced with major regulatory agencies globally, ensuring accuracy and compliance.
Technology-enabled solutions
Integrated tools and processes reduce review cycles and expedite document completion.
Certara: Leading regulatory writing with precision and innovation
Expertly crafted documents for every stage of drug development
Drug discovery
- Integrated product development plan
- Target Product Profile (TPP)
- SOPs
Pre-clinical development
Chemistry, Manufacturing, and Controls (CMC) writing:
- Method validation reports
- Stability reports
- Analytical procedure
- Manufacturing processes
- Process validations
- Pharmacology studies
- Toxicology reports
- Stability reports
Initial clinical trial applications
- Meeting requests
- Briefing packages
- IND/CTA/CTIS applications
- CTA redactions
- Agency responses
Clinical development: phase I, II, III
- Protocols (design and amendments)
- Protocol registration and maintenance
- Investigator’s Brochures (IB)
- Initial IB and updates
- Clinical Study Reports (CSR)
- Study results postings and document redaction
- Lay Language Documents
- Patient Narratives
- Development Safety Update Report (DSUR)
- EOP2 meeting request and briefing package
- Pediatric Investigation Plans (PIP)/Pediatric Study Plans (PSP)
Marketing application
- Meeting requests
- Briefing packages
- Labeling
- NDA/MAA/BLA/ANDA/IDE applications
- Agency responses
- FDA 120-day safety update
- Risk Management Plan (RMP)
Post-marketing
- Line extensions
- Supplemental filings
- Non-interventional CSRs
- Phase IV Protocols
- IBs
- CSRs
- Manuscripts
- HC PRCI and EMA policy 0070
- 0070 redaction and anonymization support
- CCI/CBI consulting
Aggregated safety reporting
- Periodic Benefit-Risk Evaluation Reports (PBRER)
- Periodic Adverse Drug Experience Reports (PADER)
- RMPs and RMP updates
- Benefit-risk analyses
- Development Safety Update Reports (DSUR) and Briefing Packages
Meet our regulatory writing experts
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Partner with Certara to optimize your regulatory submissions. Our team of expert writers ensures your documents meet global standards, accelerating your drug development milestones.
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FAQs about regulatory writing services
What types of documents do you support?
We support clinical, CMC, and nonclinical documentation across the full drug development lifecycle.
How does Certara ensure document quality?
Our SOPs and dedicated QC teams drive consistency and minimize review cycles.
Can Certara handle global regulatory submissions?
Yes, our team has experience with major global regulatory agencies, including the FDA, EMA, and PMDA.
Who benefits from Certara's AI technology?
Certara’s experienced regulatory writers harness the power of our advanced AI technology to deliver submissions with unmatched efficiency and precision.
Can Certara’s AI technology work for me?
Absolutely! Connect with us to explore how this cutting-edge solution can be tailored to meet your regulatory needs.
Why combine Certara’s AI technology with Certara's expert regulatory writers?
Our writers go beyond the technology—they’ve evolved alongside AI. Combining deep expertise, strategic foresight, and years of industry experience, they ensure every submission is optimized for success.
What is AI-enabled regulatory writing?
It is the use of advanced AI tools to accelerate and improve the quality of regulatory documentation.
How does Certara’s CoAuthor platform work?
CoAuthor uses a specialized GPT model and advanced features like structured content authoring to streamline the writing process.
Can Certara support submissions across therapeutic areas?
Yes, Certara has expertise in a wide range of therapeutic areas, backed by a team of 400+ experts.