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Regulatory Writing

Regulatory Medical Writing Services

Med Communications offers regulatory writing support across all stages of clinical drug development. Tap the blue boxes to learn more. 

  • Clinical Trial Protocol Development 

    • Phase 1 through Phase 4 
    • Protocol amendments 
    • Protocol concept documents 
    • Plain-language protocol synopses 
    • Master protocols 
    • Informed Consent Forms 

  • Investigator’s Brochures 

    • De novo Investigator’s Brochures (IBs) 
    • Annual updates 
    • Concise, streamlined content 

  • Clinical Study Reports 

    • Phase 1 through Phase 4 
    • Pivotal, interim, and final 
    • Abbreviated and synoptic 
    • CSR appendix collection 
    • CSR addenda 
    • CSR amendments 

  • Submission Support 

    • Briefing packages  
    • Clinical Summaries 
    • Clinical Overviews 
    • Integrated Summary of Safety 
    • Integrated Summary of Efficacy 
    • Integrated Summary of Immunogenicity 
    • Assessment Aids 
    • Responses to Agency Questions 

  • Quality Control 

    • Medical editing 
    • Adherence to style guide and program lexicon 
    • Internal consistency 
    • 100% data check 

  • Safety Narratives 

    • Client’s existing or custom template 
    • Clear, organized presentation of patient data 
    • Expert medical review 

  • Aggregate Safety Reports 

    • Periodic Adverse Drug Experience Report (PADER or PAER) 
    • Periodic Benefit-Risk Evaluation Report (PBRER) 
    • Periodic Safety Update Report (PSUR) 
    • Development Safety Update Report (DSUR) 

  • Clinical Trial Publications 

    • Clinical trial publication authoring, journal selection, and submission 
    • Plain language abstracts 
    • Congress abstracts, posters, and slide decks 
    • Graphical abstracts and infographics 

Med Communications’ regulatory writing team brings experience and quality to every client and every project. Whether you need support for a single document or an entire clinical development program, our scientist-writers work as an integrated part of your team to develop content tailored to your regulatory needs and according to your deadline. We offer functional service provider, hourly, or project-based engagements. 

What our clients say

Our Regulatory Writing team member is a phenomenal medical writer and project lead. She is thorough, highly detail oriented, and has a deep understanding of the regulatory landscape. She also brings a lot of grace to her teams — she is appropriately communicative, clear, timely, and proactive. I always have an incredible degree of confidence when she is on my projects.

-Regulatory writing lead in rare disease indication, mid-size pharma company

I interacted with our regulatory writer almost daily on both a personal and professional level. The quality of her work as a medical writer is exceptional and her training was invaluable. She has a deep knowledge of regulation and health authority guidance, and her experience has spanned most regulatory documents types and regulatory scenarios. Beyond that, her project leadership soft skills are beyond compare, with great insight and intuition on how to gain team consensus and keep medical writing projects moving forward. I consider myself fortunate to count [her] as a mentor and friend, and I would enthusiastically endorse her as a highly skilled regulatory medical writer and leader.

-Global Medical Writing Team Lead, Top 20 Pharma Company

Our Med Communications regulatory writer is a leader in the medical writing field. Her high-quality deliverables reflect meticulous attention to detail in both precision and clarity, and are always delivered on time. She provides scientific and regulatory expertise and a deep knowledge of best practices in regulatory writing. She works with sponsor teams to efficiently author documents that reflect the sponsor’s key messaging and strategic goals and also meet regulators’ requirements.

-Clinical Submissions Lead, Mid-size Pharma Company specializing in Infectious Disease

The regulatory writer is a remarkable leader in the medical writing field whom I have had the pleasure of knowing for almost 15 years. I’ve worked with her directly on key regulatory documents, watched her manage and mentor other writing consultants when I hired them, and benefitted from her experience both within and outside of our formal working relationship.

She has consistently demonstrated an exceptional understanding of the medical writing skills needed to present complex scientific concepts clearly and credibly to a specific target audience. While maintaining appropriate use of sensitive clinical data and adhering to good clinical practice guidelines, she ensures the highest quality in document production. She is also flexible and finds creative solutions to meet tight deadlines, adapting to changes in plans.

She remains professional and calm under stress, earning the trust of her colleagues and the teams with whom she works. She is approachable and genuine, eager to help, and an excellent resource for all medical writing needs.

-Regulatory Writing Submission Leader, Top 20 Pharma Company, First-in-class submission

The Regulatory Writing team member was a terrific colleague who provided high-quality documents on time and in great shape. I would work with her again in a heartbeat!

-Regulatory Writing Department Head, Top 20 Pharma Company, Oncology

Strategic Consulting 

Our medical writing team has broad document and therapeutic area expertise, together with a deep understanding of regulatory requirements. We understand the regulator’s approach to document review and how that aligns with lean authoring principles. We can guide your team to produce concise and compliant regulatory documents. Med Communications also offers “rescue regulatory writing” services when your current vendor isn’t providing the level of quality or service that your team requires.  

Project Management 

At Med Communications, we know that content is only one step on the road to success. Our regulatory writers have the organizational, communication, and collaboration skills required to guide your project from planning to completion. 

  • Timeline development: Our writers will collaborate with your team to develop timelines that meet your deadlines and accommodate the conflicting demands on their time. 
  • Individual document management: Our writers will shepherd your document from kickoff meeting through finalization and internal approval. We will follow your process or share our own best practices. 
  • Submission management: Our experienced regulatory writers can help develop strategies to facilitate parallel, coordinated development of pivotal clinical study reports, Module 2.7 summaries, and Module 2.5, while ensuring alignment across documents.

Schedule Your Consultation

When you need expert regulatory medical writing support, our scientifically trained, industry-experienced PhD, PharmD, and healthcare professionals can lead your team to success. Our medical writers apply their extensive experience to every project, ensuring your clinical development documents are completed on time and meet the highest standards.

From clinical trial applications and investigational new drug applications to marketing applications to the FDA, EMA, and other regulatory agencies, we handle your data, documentation, and confidential information with our comprehensive quality assurance practices. Our systematic approach incorporates quality at every stage — from kickoff to quality control review, finalization, and document approval — while maintaining our commitment to timely delivery through stringent processes established before project initiation.

Our exceptional team also sets us apart, with 31% of our writers having experience across industry, clinical, and academic settings. Whether you need assistance with a drug application or strategies for regulatory compliance, our specialists provide the expertise that regulatory affairs professionals trust.

Our ongoing staff training and continuous feedback loop ensure we remain at the forefront of medical communications, offering a range of services that satisfy regulatory agencies and your business objectives. Don’t let regulatory writing challenges delay your product development timeline. Contact us today and discover how our extensive experience can support your regulatory needs while maintaining the quality excellence that defines our reputation.

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