Medical writing – delivering specialty knowledge

An integral part of the regulatory process is writing thousands of pages of documents that ultimately make up a submission. Medical writing is a highly specialized field that involves bringing together information from clinical trials, safety reports and other key documentation to create a dossier.

Celegence – medical writing expertise

Celegence’s global medical writing specialists are experts in therapeutic area and product type, with deep knowledge of scientific, technical, and medical subjects relevant to the product. Our medical writers have 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 abstracts, manuscripts, and presentations.

Celegence’s niche medical writing services include:

  • Preparing, writing, editing, and reviewing regulatory documents and responses to regulatory authorities
  • Routine systematic literature reviews for particular therapeutic and product areas
    Organizing and incorporating information for documents, such as references, graphics, tables, and data listings
  • Reviewing and providing input on clinical data
  • Providing insight into clinical research, device/drug development processes, regulatory requirements, good clinical and data management practices

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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