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 Need for Multiple Vendors
Reduce Speed Through Streamlined Services
Support Global Multilingual Content
Ensure 100% Compiant Content
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 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

  • 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 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 to strategic decision-making.
 

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Other department capabilities

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

  • Electronic/website content, design, and web implementation
  • Preparation of training course material
  • 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 (e.g. journal articles) for non-native speakers Proof-reading and formatting of documents (e.g. for regional requirements, journal submissions)

Any Customer. Any Language. Any Channel.

We Know How

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