Medical Writing Services

Treximo writers, editors, and quality reviewers team with you to generate clear, concise text with exceptional quality during each stage of the document development lifecycle.

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Medical Writing Expertise Tailored to Your Project and Therapeutic Area Needs

We target your project needs and unique therapeutic area requirements during writer selection. We bring the most experienced resources with deep subject matter expertise to the table, ensuring the best fit with your overall project team. The end result is a high-quality deliverable tailored to the appropriate reviewer audience.

Therapeutic Areas We Support

  • Cardiovascular
  • Central Nervous System
  • Diabetes and Endocrine/Metabolic
  • Immunology
  • Immunotherapy
  • Neuroscience/Neurology
  • Onco-immunology
  • Oncology
  • Opthamology
  • Pulmonary/Respiratory
  • Rare and Orphan Diseases
  • Rheumatology
  • Vaccines

Full Document Support Across Modules 1-5 of the eCTD

What We Do

Regulatory Writing Life Cycle Management

Briefing Documents

Protocols, CSRs, and Amendments

CMC/GMP Documents

IND/NDA/ANDA/MAA/ BLA

Safety Narratives

Annual Reports

Benefit/Risk Assessments

Biologics License Applications

Clinical and Nonclinical Overviews

Pre-IND Briefing Packages/Briefing Books

Protocols and Amendments

Abstracts

Continuing Medical Education Program Planning

Manuscripts

Posters

Publication Strategy

DSUR

Investigator Brochures

Clinical Study Reports (Full, Abbreviated, and Addendums)

Development Safety Update Reports

Informed Consent Forms

Integrated Summaries of Safety and Efficacy

Investigational New Drug Applications

Pediatric Study Plans

Periodic Benefit-Risk Evaluation Reports

Content Editing and Proofreading

QC Review Of Data Against The Text

Populating Tables And Building Figures

Literature Searches, Analyses, Reference Libraries, and Citations

Orphan Drug Applications

505(b)(2)

Investigator Brochures and Annual Updates

Medical Device Clinical Evaluation Reports

Narratives

New Drug Applications

Scientific Advice Documents

Word Processing and Formatting

Compilation, Hyperlinking, and Publishing

Style-Guide and Template Adherence and Creation

FDA Advisory Committee Experience

Clinical Evaluation Reports

Safety Aggregate Reports

Orphan Designation Documents

Pediatric Investigation Plans

Periodic Safety Update Reports

Regulatory Responses

Medical Writing Experts on Demand.

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Proven Quality

The repeat business we receive is a testament to our insistence on quality at each stage of the document development lifecycle.

Diverse Writer Skillset

With years of experience and therapeutic area expertise, our writers are strong scientific communicators with additional strengths in project management, team and review cycle management, data analysis, and key messaging.

Cost-Effective Solution

Our medical writing services can help fill in your resourcing gaps, while also providing an effective reduction in your payroll outlay. You receive on-demand talent with the ability to easily bundle services at a lowered cost.