Medical Writing Services

A trusted global leader in delivering strategic, responsive, and adaptable medical writing support.

Delivering highly qualified engineers, regulatory experts, quality assurance specialists, and more — fast, reliably, and with industry precision.

serving the life sciences, technology, and healthcare sectors

From single-document support to complete outsourcing across clinical trials or product portfolios, our deep expertise enables us to consistently deliver high-quality medical writing that aligns with your strategic objectives

Precision Talent Group delivers comprehensive medical writing and document management services to support every stage of the drug development lifecycle, from clinical and safety documentation to broader scientific communications.

Our strength lies in the deep experience of our network and the exceptional ability of our medical writers to analyze complex scientific data and transform it into clear, concise, and accurate deliverables that meet the highest standards of quality and compliance.

Challenge

Our Solution

Benefit

Our Medical Writing Portfolio

With a proven track record, our team has executed hundreds of clinical, safety, and scientific writing projects—covering a broad spectrum of document types, such as:

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Clinical

  • Clinical Study Reports (CSRs)
  • Protocols and Protocol Amendments
  • Investigator’s Brochures (IBs) and IB Updates
  • Regulatory Submission Summary Documents (IND/NDA/MAA/CTA)
  • Responses to Questions (RTQs)/Regulatory Responses (across multiple health authorities)
  • Pre-Meeting Packages/Briefing Packages
  • Orphan Drug Applications
  • Pediatric Investigation Plans
  • Pediatric Study Plans (including waivers)
  • Health Outcomes Economics/Real World Evidence Documents
  • Fast Track Designation
  • Orphan Drug Designation (ODD) Application/Annual Reports
  • Immunogenicity Reports
  • Ethnic Sensitivity Reports
  • Conditional Marketing Authorization (CMA)

Safety

  • Development Safety Update Reports (DSURs)
  • Periodic Benefit Risk and Evaluation Reports (PBRERs)
  • Periodic Safety Update Reports (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Risk Management Plans
  • Assessment of Benefit Risk (ABR)
  • Annual Reports
  • Patient Safety Narratives

Non-Clinical

  • Pharmacology, Pharmacokinetic, and Toxicology Reports (in vivo/in vitro)
  • Bioanalytical Reports

Diagnostics

  • Protocol Proposals
  • Clinical Validation Plan/Clinical Performance Plan
  • Clinical Validation Report/Clinical Performance Report
  • Clinical Study Protocols (CSPs)
  • Clinical Study Reports (CSRs)
  • Intended Use Statements
  • Performance Evaluation Plan (PEP)
  • Performance Evaluation Report (PER)
  • State-of-the-Art Determination (SOTA)
  • Scientific Validity Report (SVR)
  • Medical Assessment
  • Medical Opinion Documents

Devices

  • Clinical Evaluation Plans (CEPs)
  • Clinical Evaluation Reports (CERs)
  • Investigational Device Exemption (IDE)

Publications

  • Scientific Manuscripts/Abstracts
  • Posters
  • Literature Reviews/Summaries
  • Oral Presentations

Other Scientific Documents

  • Plain Language Documents (protocol synopses, results summaries)
  • Informed Consent Forms (ICFs)
  • Regulatory White Papers
  • Consumer Health Product Documents

Have additional medical writing questions?

We'd be happy to talk with you about your unique needs and goals.