Medical Writing

Medical Writing & Publication Services

A one-stop shop for your clinical and non-clinical documentation needs.

Authoring & Editing

Patient Advocacy Review

Dissemination

Document Storage

Quality Control

Training

Graphic Design

Translation

SME Advisory Support

Eliminate the Need for Multiple Vendors
Fast Delivery Through Streamlined Services
Global Medical Writing and Translation Support
Ensure 100% Compliance with Our Medical Writing
Achieve Quality and On-Time Delivery

MEDICAL WRITING CAPABILITIES

Scientific Writing

  • Manuscripts
  • Communication Briefs
  • Systematic Reviews & Meta-Analysis
  • Literature Reviews
  • Posters
  • Slide Decks
  • Conference Reports
  • Plain Language Abstracts

Regulatory Medical Writing

  • Protocols, CSRs, IBs & ICFs
  • Non-Clinical & Clinical Overviews
  • Patient Narratives
  • Package Inserts & Labels
  • INDs, IMPDs, & Annual Reports
  • Global CTA Applications
  • NDAs, PMAs, 510k, Design Dossiers
  • Responses to Health Authorities
  • Post-Approval Submissions: Annual Reports, Renewals, Compliance Filings, Supplemental PMAs

Transparency & Disclosures

  • Protocol Registrations & Result Disclosures for CT.Gov & EudraCT
  • National Registries
  • Plain-Language Summaries
  • Individual Patient Data Sharing
  • Redaction & Anonymization per Policy 0070, 043 & Third-Party Requests
  • Health-Canada Public Release of Information

Medical Information & Types of Medical Writing

  • Medical Information Response Documents
  • Proceedings
  • Monographs
  • Training Material
  • Copywriting
  • Website Content
  • Health Articles
  • Dossier Summaries

Clinical Data Transparency & Public Disclosures: Overcoming Challenges with Prospective Writing

In the regulatory medical writing industry, prospective writing can be an enticing approach if adopted strategically. Thinking about future outcomes in response to current actions is an obligatory precedent for strategic decision-making.
 

Download

Other department capabilities

Whether your needs are temporary or ongoing, our services include:

  • Electronic/website content, design, and web implementation
  • Preparation of medical writing training material
  • Arrange travel to conferences/advisory board meetings
  • Graphic design of any medical writing piece
  • Patient/HCP advisory board review SME advisory support (gap analyses, regulatory advice, training, & risk-based audits)
  • English-language editing and QC of scientific documents such as journal articles for non-native speakers
  • Extensive and thorough proofreading
  • Formatting of documents such as for regional requirements & journal submissions
  • Global medical writing and translation

Any Customer. Any Language. Any Channel.

We Know How

-- close --