Medical writing – delivering specialty knowledge

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. Medical writing is a highly specialized field that involves bringing together information from clinical trials, safety reports and other key documentation, with the ultimate goal of producing submission ready documents for the targeted audience.

Celegence – 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 and perfectly integrated with technical, editorial and quality control capabilities. Our medical writers are well versed in working with various stakeholders like clinical operations, data management, bio-statistics, medical and safety teams. Our team also has broad industry experience, drawn from pharmaceutical and medical devices companies, CROs and service providers, and academia and are experienced in all forms of medical and scientific writing, including regulatory, clinical, safety and publication documents.

Celegence’s niche 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 writing, editing, and full and comprehensive review of regulatory and scientific documents and responses to regulatory or health authorities
  • Routine systematic literature reviews for particular therapeutic and product areas
  • Organizing and incorporating information for documents, such as clinical and scientific results, evaluation reports, literature contents 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 as to comply with ICH requirements and manual of styles.
  • Timely delivery with utmost focus on the high standard 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, RTQs
  • 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 Report (PBRER)/Periodic Safety Update Reports (PSURs), Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER)/Periodic Adverse Experience Report (PAER), Semi-annual safety update report (SSUR), and safety reports specific to individual country requirements
  • Publication Documents such as Manuscript, Posters and presentations, slide decks advertising/promotional materials

Learn more about our niche service offerings:

MEDICAL DEVICES

Medical devices – addressing a changing regulatory environment

REGULATORY LABELING

Regulatory labelling – supporting clients from creation to maintenance

PUBLISHING AND ECTD SERVICES

Publishing and eCTD services – tackling global submission challenges

REGULATORY OPERATIONS MANAGEMENT

Managed regulatory operations related to publishing, submission and regulatory information management for reduced total cost of ownership

IDMP & COMPLIANCE CONSULTING

Organizational readiness assessment for IDMP, xEVMPD and UDI compliance and support activities like data collection, maintenance, submission and governance

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