Certara

Address:
Email: services@certara.com
Website: https://www.certara.com/regulatory-science/regulatory-writing/
Phone: +49 30 767594266

Skills and Services:

Certara assures and accelerates the approval of, and access to, medical innovations through a unique combination of customized regulatory strategy, document authoring, medical affairs and scientific communications, and regulatory operations solutions empowered by technology. We provide services to author clinical, CMC, and nonclinical documents required throughout the full drug development lifecycle.

Expertise:

Our proven record of success is built on our expertise and an unrivaled commitment to quality and compliance combined with the use of advanced technologies to enhance speed and efficiency.

Regulatory Strategy

• Gap Analysis
• Labelling development and alignment with TPP
• Regulatory strategic planning to support product development of drugs [including products via 505(b)(2)], biologics, biosimilars, cell and gene therapies, and generics
• Expedited programs (e.g., Fast track, Breakthrough designation, PRIME)
• Health authority meetings (e.g., Pre-IND, EPO1, EOP2, Pre-NDA/BLA, Scientific Advice)
• Orphan drug designations

Document Authoring

• CMC and nonclinical writing – nonclinical reports, initial IB, CMC reports, CMC and nonclinical modules
• Clinical Submissions writing – IND/IMPD applications, NDA/BLA applications, briefing documents, clinical CTD modules, regulatory responses, 120-day safety reports
• Study level documentation – protocol design and development, IB Updates, protocol amendments, CSR, narrative writing, lay language writing
• Safety and Annual Reports – DSURs, PSURs/PBRERs and PADERs, RMP and RMP updates, Safety Assessment Reports, Addendum to Clinical Overview
• Document publishing and quality control

Medical Affairs and Scientific Communications

• Manuscripts
• Global and Regional Congress Support – abstracts, posters, oral presentations, congress reporting, video abstracts and talking points
• Publication Planning
• Medical Affairs/Medical Information – standard and global response letters, monographs, literature reviews, medical slide sets, grant applications, white papers, artistic educational materials, and storyboards
• Professional and Graphic Design and Video

Regulatory Operations

• Submission-level publishing
• Marketing application and investigational and master file submissions
• Lifecycle maintenance submissions
• US Agent services
• Electronic transmissions
• Global submissions to FDA, EMA, MHRA, Swiss Medic, TGA, and Health Canada regulatory authorities

Transparency and Disclosure

• Trial Registrations and Results – protocol registrations, clinical study results postings
• Lay Language Documents – protocol synopses, summaries of results, informed consent forms 
• Redaction and Anonymization – CTA documents for CTIS, dossier redaction/anonymization for EMA Policy 0070 and Health Canada PRCI

Tech-enabled Services

• CoAuthor™ – combining industry leading writing services alongside purpose-built AI technology, CoAuthor provides transparency, consistency, and collaboration to allow medical writing teams to accelerate the drafting and submission of quality and compliant regulatory documents.
• GlobalSubmit™ eCTD Software – Certara’s tool to efficiently publish, validate, and review eCTD submissions
• Clingenuity Redaction Management Solution (CRMS) – Certara’s AI tool that uses statistical models to determine the data to be redacted or anonymized, allowing to redact thousands of pages consistently and accurately.

Other Information:

• With full-time teams in North America, Europe, and Asia-Pacific, we provide 24-hour support and the flexibility and scalability required for rapid response to your most urgent needs.
• Principal regulatory writers average more than 20 years of experience
• 67% of our writers hold advanced degrees (primarily within a scientific discipline), and a majority having additional industry accreditation
• We have experience in most therapeutic areas, including over 100 different indications
• Certara has 5 specialty practice areas (Early Development, Rare Diseases, Pediatrics, Clinical Pharmacology Study Execution Team, Complex Biologics) which are supported by a variety of pharmacometricians, clinical pharmacologists, regulatory strategists, toxicologists, etc. that provide complete support on these specific topics  

 

Certara’s solutions, which span the drug development and patient care lifecycle, help increase the probability of regulatory and commercial success by using the most scientifically advanced modeling and simulation technologies and regulatory strategies.