An integral part of the drug approval and submission process is to create well-written and well-structured documents that comply with applicable regulations and authorities. Regulatory medical writing is a highly specialized field that involves bringing together information from clinical trials, safety reports and other key documentation, with the goal of producing submission ready documents for the targeted audience.
Celegence: Regulatory Medical Writing Expertise
Celegence’s global medical writing specialists are experts in the drug development process, multiple therapeutic areas and product types, with in-depth knowledge of regulatory, clinical, and scientific contents perfectly integrated with technical, editorial and quality control capabilities. Our medical writers are well versed in working with various stakeholders such as clinical operations, data management, biostatistics, medical and safety teams. Our team also has broad industry experience, drawn from pharmaceutical and medical devices companies, CROs and service providers, and academia with extensive experience in all forms of medical and scientific writing, including regulatory, clinical, safety, and publication documents.
Celegence’s Medical Writing Services Include:
Strategic services in medical and scientific writing, integrated planning and execution, coordination of all writing and review activities across various domains and therapeutic areas.
End-to-end support for medical writing, editing, full and comprehensive review of regulatory and scientific documents, and responses to regulatory and health authorities.
Routine systematic literature reviews for particular therapeutic and product areas.
Organizing and incorporating information to documents, such as clinical and scientific results, evaluation reports, literature content references, graphics, tables, and data listings.
Reviewing and providing input on medical and scientific data, including gap analyses.
Providing insight into clinical research, device/drug development processes, regulatory requirements, good clinical, and data management practices.
- Expert in-house quality check for all documents to comply with ICH requirements and manual of styles.
Timely delivery with utmost focus on high standards of quality.
End-to-end support for the following types of documentation:
- Clinical documents such as Protocols
- Investigator Brochures (IBs)
- Case Report Forms (CRFs)
- Clinical Study Reports (Phase 1 to 4)
- Informed Consent forms (ICF)
- Clinical and non-clinical summaries
- Safety narratives/summaries
- Regulatory documents such as Company Core Data Sheets (CCDS), Risk Management Plans (RMP), Proposed prescribing information (PPI), Package Inserts/Medication Guides, United States product insert (USPI), Summary of Product Characteristics (SmPCs), INDs, NDAs, MAAs and other international drug submissions, Briefing documents for agency meetings.
Pharmacovigilance documents such as Periodic Benefit Risk Evaluation Reports (PBRER), Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSUR), Periodic Adverse Drug Experience Reports (PADER), Periodic Adverse Experience Reports (PAER), Semi-annual safety update reports (SSUR), and safety reports specific to individual country requirements.
Publication documents such as Manuscripts, Posters and presentations, slide decks of advertising/promotional material.
If you’re curious how Celegence can help improve your Medical Writing then fill out the below and one of our team members will get in touch with you.