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Medical Writing Solutions

With a team of experienced contract medical writers from around the globe, we bring diverse expertise to every project. While our specialty lies in regulatory and clinical medical writing, we’re equipped to handle a wide range of additional medical writing needs.

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Discover our tailored solutions below:

Regulatory

Regulatory

  • Scientific Advice Meetings

  • Regulatory Responses

  • Orphan Drug Designations

  • Fast Track Designations

  • Breakthrough Designations

  • Accelerated Approvals

  • IND/CTA

  • Pediatric Investigation Plans/Pediatric Study Plans

  • NDA/BLA/MAA

Signing Contract

Regulatory

Nonclinical

Nonclinical

  • Nonclinical reports

  • Meeting Request Letters & Briefing documents

  • CTD Module 4 Compliance

  • CTD Module 2

  • IB

Petri Dish

Nonclinical

Medical Devices

Medical Devices

  • Clinical Evaluation Plans

  • Clinical Evaluation Reports

  • Clinical Literature Reviews

  • PSURs

  • Clinical Investigation Plans

  • Summaries of Safety & Clinical Performance

Blood pressure monitor

Medical Devices

Clinical

Clinical

  • Clinical Trial Protocols

  • Investigational Medicinal Product Dossiers (IMPD)

  • Clinical Development Plans

  • Protocol Synopses & Study Designs

  • CTD Module 2

  • Clinical Study Reports & Narratives

  • Investigator's Brochures (IB)

Happy Doctor

Clinical

Safety

Safety

  • Development Safety Update Reports

  • Periodic Safety Update Reports (PSUR/PBRER/PADER)

  • Safety Narratives

  • Risk Management Plans

  • Risk Evaluation and Mitigation Strategies

  • Benefit-Risk Assessments Annual Reports

medical writing about safety.jpg

Safety

Medical Communications

Medical Communications

  • Posters

  • Abstracts

  • Manuscripts

  • Journal Selection and Submission Activities

  • Conference Proceedings

  • Slide Decks

  • Plain Language Summaries

Meeting

Medical Communications

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