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.
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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.
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Timely and reliable submissions
We deliver on-time, compliant documents to keep your drug development program on track.
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Global regulatory expertise
Our writers are experienced with major regulatory agencies globally, ensuring accuracy and compliance.
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Technology-enabled solutions
Integrated tools and processes reduce review cycles and expedite document completion.
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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
Nonclinical
- CTD Module 2.4 and 2.6
- CTD Module 4, including:
- Pharmacology studies
- Toxicology reports
- PK reports
CMC & Analytical
- CTD Module 2.3 and 3
- Analytical procedures
- Method validation reports
- Stability reports
Manufacturing & Validation
- Manufacturing processes
- Process validation 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)
- Investigator’s Brochure (IB) (Initial and Updates)
- 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
- Paediatrics Investigation Plans (PIP)/Pediatric Study Plans (PSP)
Marketing application
- Meeting requests
- Briefing packages
- Labeling
- New Drug Application (NDA), Marketing Authorization Application (MAA), Biologics License Application (BLA), Abbreviated New Drug Application (ANDA), and Investigational Device Exemption (IDE), applications, New Drug Submission (NDS)
- Agency responses
- FDA 120-day safety update
- Risk Management Plan (RMP)
- Periodic Report of Clinical Investigations (PRCI) and EMA Policy support
Post-marketing
- Line extensions
- Supplemental filings
- Non-interventional CSRs
- Phase IV Protocols
- IBs
- CSRs
- Manuscripts
- HC PRCI and EMA policy 0070
- Commercial Confidential Information (CCI) (EU) and Confidential Business Information (CBI) (Health Canada)
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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Experts
Steve Sibley
Vice President, Global Submissions and Submission Leadership
With over 30 years of expertise in the pharmaceutical industry, Steve Sibley drives innovation in regulatory writing as a consultant and leader of the global submissions service line at Certara Drug Development Solutions (CDDS).
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Experts
Maria Lopez
Director, CMC and Nonclinical Regulatory Writing
With over 26 years at Certara, Maria has driven progress and excellence, evolving from regulatory writing and quality assurance to leading our nonclinical/CMC regulatory writing team—a testament to her expertise and transformative leadership.
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Experts
Evan Richardson
Senior Director, Regulatory Operations and Clinical Disclosure
Evan Richardson brings 18 years of pharmaceutical industry expertise to his role as Senior Director of Transparency and Disclosure Services at Certara. Over his career, Evan has navigated the complexities of drugs, biologics, and medical devices, working across organizations of all sizes—from startups to global enterprises.
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Experts
Laura Sheppard
Regional Head for Clinical Regulatory Writing for North America and Lay Language Management
Ms. Sheppard is a seasoned leader in global submissions and medical writing, with expertise spanning regulatory strategy, clinical transparency, and project management. With 20 years of experience in translational science and clinical development—and 15 years dedicated to medical writing.
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Experts
Related resources
View allContact us for expert regulatory writing services
Partner with Certara to optimize your regulatory submissions. Our team of expert writers ensures your documents meet global standards, accelerating your drug development milestones.
Expertise across clinical, CMC, and nonclinical disciplines.
Proven track record of timely, compliant submissions.
Comprehensive support for global regulatory requirements.
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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 support regulatory writing across diverse therapeutic areas?
Certara offers regulatory writing support across a broad range of therapeutic areas, including oncology, metabolic and weight-loss therapies, orphan and rare diseases, and more.
How does Certara support clinical narrative writing?
Certara integrates AI-driven technologies with expert medical writing to produce scalable, high-quality patient narratives, ensuring speed, consistency, and scientific excellence across safety deliverables.
How does Certara support global clinical transparency?
Certara offers comprehensive clinical disclosure services to ensure accurate, compliant, and timely public disclosure of clinical documents across regions.
