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September 23, 2024

Together for Documenting Results

Medical Writing

The Medical Writing function is an integral part of clinical development. It demands specialized writing skills, compliance with stringent regulatory guidelines, addressing diverse audience needs, maintaining data integrity, and communicating complex research data effectively and in a timely manner, catering to the ever-changing regulatory landscape. APCER Life Sciences Medical Writing Team collaborates closely with you to bring your research to physicians and other healthcare providers, patients, caregivers, regulators, and other stakeholders in the healthcare industry by effectively communicating scientific data in the right context through well-crafted documents across the lifecycle of a product.

By leveraging efficient technology platforms and established project governance practices, APCER develops smooth collaboration for timely delivery of projects through seamless data transfer and knowledge exchange.

APCER, a trusted global service provider, delivers high-quality medical writing documents for all your clinical, regulatory, and scientific writing needs – and advanced therapy medicinal products (ATMPs) from drugs and medical devices to biologics and ATMPs.

Medical Writing Services

Clinical Writing
  • Protocols
  • Informed Consent Documents
  • Investigator’s Brochures
  • Patient Safety Narratives
  • Clinical Study Reports
  • Clinical Trial Disclosures
    1. Protocol Registration Forms
    2. Basic Results
    3. Web Synopses
    4. Layperson’s Summaries
    5. Redaction Services
Regulatory Writing
  • Investigational New Drugs/New Drug Applications/Biologic Licensing Applications
  • Clinical Trial Application/Marketing Authorization Application
  • Common Technical Document Modules (2.4, 2.5, 2.6. 2.7, 4, 5)
  • Briefing Documents for meetings with regulatory authorities
  • Pediatric Investigational Plans
  • Drug Designations (Orphan Drug Designation, Accelerated Review Application, Priority Review Application, etc.)
  • Annual Reports
  • Company Core Data Sheets
  • Drug monographs
  • Labels: SmPCs/PIs; PILs/Medication Guides
Scientific Communication
  • Manuscripts/Review articles
  • Conference Support: Abstracts, Posters, and Slide Decks
  • Infographics, HTML e-mailers
  • Newsletters
  • Leave-Behind Leaflets
  • Continuing Medical Education Slide Decks
  • Web Content
  • Standard/Customized Response Letters
Medical Devices
  • Clinical Investigation Plans
  • Clinical Evaluation Plans
  • Clinical Evaluation Reports
  • Post-Market Clinical Follow-Up Plans
  • Post-Market Clinical Follow-Up Reports
  • Summaries of Safety and Clinical Performance
  • Periodic Safety Update Report
  • Post-Market Surveillance Plans
  • Post-Market Surveillance Reports
Quality Control Review

Quality Control review of clinical, regulatory, and scientific documents.

Post-Approval Support
  • Support for Additional Risk Minimization Measures (aRMMs)
    1. Preparing protocols, informed consent documents, and clinical study reports for:
      • Registry/Observational Studies
      • Real-World Evidence (RWE) Studies
      • Post-Authorization Safety Studies (PASSs) and Post-Authorization Efficacy Studies (PAESs)
      • Observational Pharmacoepidemiologic Studies
      • Clinical trials with safety endpoint [Section 505(o)(3)]
  • Annual Update/Annual Reports
    1. Updating clinical and nonclinical sections, as applicable
    2. Preparing annual reports for registry/observational studies
  • Variation Filing
    1. EU: Safety variation filings
    2. SmPC/PIL Safety Update/Annual Review; Clinical Expert Statement (CES) preparation
  • Reimbursement Dossiers – clinical and nonclinical sections
  • Review of advertising and promotional materials
  • Educational materials (brochures, handouts, e-learning modules, content for CMEs, physicians, patients, and salesforces)

Medical Writing Services

  • Clinical Writing
  • Regulatory Writing
  • Scientific Communication
  • Medical Devices
  • Quality Control Review
  • Post-Approval Support
  • Protocols
  • Informed Consent Documents
  • Investigator’s Brochures
  • Patient Safety Narratives
  • Clinical Study Reports
  • Clinical Trial Disclosures
    1. Protocol Registration Forms
    2. Basic Results
    3. Web Synopses
    4. Layperson’s Summaries
  • Investigational New Drugs/New Drug Applications/Biologic Licensing Applications
  • Common Technical Document Modules (2.4, 2.5, 2.6. 2.7, 4, 5)
  • Briefing Documents for meetings with regulatory authorities
  • Paediatric Investigational Plans
  • Drug Designations
    (Orphan Drug Designation, Accelerated Review Application, Priority Review Application, etc.)
  • Annual Reports
  • Company Core Data Sheets
  • Drug monographs
  • Labels: SmPCs/PIs; PILs/Medication Guides
  • Manuscripts/Review articles
  • Conference Support: Abstracts, Posters, and Slide Decks
  • Infographics, HTML e-mailers
  • Newsletters
  • Leave-Behind Leaflets
  • Continuing Medical Education Slide Decks
  • Web Content
  • Standard/Customized Response Letters
  • Clinical Investigation Plans
  • Clinical Evaluation Plans
  • Clinical Evaluation Reports
  • Post-Market Clinical Follow-Up Plans
  • Post-Market Clinical Follow-Up Reports
  • Summaries of Safety and Clinical Performance
  • Periodic Safety Update Report
  • Post-Market Surveillance Plans
  • Post-Market Surveillance Reports

Quality Control review of clinical, regulatory, and scientific documents

  • Support for Additional Risk Minimization Measures (aRMMs)
    1. Preparing protocols, informed consent documents, and clinical study reports for:
      • Registry/Observational Studies
      • Real-World Evidence (RWE) Studies
      • Post-Authorization Safety Studies (PASSs) and Post-Authorization Efficacy Studies (PAESs)
      • Observational Pharmacoepidemiologic Studies
      • Clinical trials with safety endpoint [Section 505(o)(3)]
  • Annual Update/Annual Reports
    1. Updating clinical and nonclinical sections, as applicable
    2. Preparing annual reports for registry/observational studies
  • Variation Filing
    1. EU: Safety variation filings
    2. SmPC/PIL Safety Update/Annual Review; Clinical Expert Statement (CES) preparation
  • Reimbursement Dossiers
  • Review of advertising and promotional materials
  • Educational materials (brochures, handouts, e-learning modules, content for CMEs, physicians, patients, and salesforces)

Why APCER Life Sciences Medical Writing?

A team of qualified and skilled medical writers including physicians, Ph.D. and postgraduates in pharmacy, and dentists, having rich experience acros multiple therapeutic areas and proficient in preparing clinical, regulatory, and scientific documents

Copyediting and Formatting Support Medical writers are supported by a team of copyeditors, who check the documents for language, grammar, and style, anc a group of formatters, who format documents for e-submission readiness

Robust SOP-driven two-step review process with 100% quality check to ensure adequacy and accuracy of the scientific content, resulting in high-quality deliverables that consistently exceed the client expectations

Customized and fully compliant end-to-end support to clients throughout the product lifecycle to meet th ever-changing regulatory landscape

DOWNLOAD MW BROCHURE

Case Studies Showing Expertise Of APCER Life Sciences Medical Writing Team

Learn More How strategic collaboration can transform FDA meetings into a pathway for regulatory success! Learn More How meticulous planning
enabled seamless CTD
module preparation!
Learn More How impactful scientific
communication can redefine
brand value
Learn More How advanced data management turned massive real-world data into actionable insights! Learn More How precision and speed delivered a comprehensive Investigator Brochure for an oncology product! Learn More How evidence-based standardization revolutionized local pain treatment recommendations! Learn More How expert medical writing accelerated product approvals by managing complex, high-volume projects!

Testimonials

  • Associate Submission Medical Writer
    APCER demonstrated extreme flexibility accommodating changes, and a number of last-minute changes were implemented quickly and correctly. I also appreciate the flexible communication during my workday, given the time zone differences between the APCER writers and myself.
    Associate Submission Medical Writer
    A leading bio-pharma company
  • Global Clinical Leader
    My experience with APCER has been excellent. The team was very helpful, knowledgeable, responsive and professional with all the work that was needed.
    Global Clinical Leader
    A leading pharmaceutical company
  • Medical Advisor, Medical Affairs
    I must commend the organizational skill, the professionalism, the clarity, the expertise on subject matter, execution excellence that APCER has exhibited in all my projects where I had collaborated…
    Medical Advisor, Medical Affairs
    A leading bio-pharma company

Let’s Work Together!

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    APCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory and technology resources to ensure that patients receive the safest, most effective therapies possible.

    We are an ISO 9001:2015, ISO 27701:2019 and ISO 27001:2022 certified company.

    ©2025 APCER Life Sciences, Inc. All rights reserved. | Privacy Policy | Web User Agreement

    Services

    • Pharmacovigilance
    • Medical Information
    • Medical Writing
    • Regulatory Affairs
    • Medical Affairs
    • Quality Assurance

    Specialty Areas

    • ATMPs
    • Medical Devices

    Insights

    • Brochures
    • Case Studies
    • Videos
    • Articles
    • Whitepapers
    • Blogs

    About Us

    • Leadership
    • Careers
    • Contact Us

    ©2023 APCER Life Sciences, Inc. All rights reserved. | Privacy Policy | Web User Agreement
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