Regulatory medical writing is essential to  product development throughout the lifecycle of pharmaceutical, biotechnological, medical device, and combination product development. At  Premier, our dedicated medical writers work as a true extension of your team, seamlessly integrating to communicate your story—however complex—in a clear, concise, and engaging manner.

Premier offers a full spectrum of regulatory  and clinical medical writing services, including developing quality documents, performing peer review and coordinating client review, conducting quality checks, and managing a wide range of regulatory writing activities.

Partnering with our experienced medical writers can help to reduce your submission lead times and product approval by ensuring compliance with complex frameworks created and used by the FDA, EMA, and APAC regulatory agencies and more.

Experienced Writers With Deep Industry Expertise

Averaging more than 15 years of experience from across the research and pharmaceutical, biotechnology and device industries, our team of well qualified, and highly skilled, medical writers bring strong analytical and communication skills to every project. They provide expertise across a wide range of therapeutic areas, including, but not limited to, analgesia, oncology, pediatrics, cardiology, neurology, dermatology, gastroenterology, endocrinology, immunology, psychiatry, ophthalmology, rare diseases, rheumatology, and as well as emerging areas such as cell and gene therapies, combination treatments, and software as a medical device (SaMD) indications and diagnostics.

Our global team has extensive experience in the development of individual study documents, both regulatory and patient-facing, as well as global submission documents associated with all stages of the development program lifecycle.  

We stay abreast of clinical advancements and industry standards, ensuring compliance with regional healthcare authority requirements, ICH and GCP guidelines, and industry best practices.

Strategic, Efficient, and Flexible Approach

We combine expertise with innovative technology to deliver tailored solutions that support trial initiation, management, and successful regulatory submissions. Our approach is defined by:

• High-Quality Output: A team of highly-qualified and specially-trained medical writing editors who work within the team to ensure delivery of the highest-quality documents
• Cross-Functional Teamwork: From single documents to entire submissions, we work seamlessly across disciplines to deliver accurate and on-time results
• Data-Driven Strategy: Our pricing and project estimates are backed by real-world experience, ensuring efficiency and transparency
• Flexibility: We adapt to evolving sponsor needs, providing scalable support throughout the development lifecycle
• Integrated Technology: We balance time-saving automation and expert review to optimize efficiency without compromising quality
• Full Lifecycle Support: We provide continuous support tailored to your program’s needs from IND to NDA (CTA to MAA) submission and approval

Using unique document suites and leveraging deep understanding of the interrelationship between clinical study documents, optimized strategy, and consistency in study delivery consistency, our team delivers innovative, compliant, and tailored solutions to meet study- and sponsor-specific medical writing needs.

Comprehensive Medical Writing Services

Our expertise spans a wide range of regulatory and clinical documentation, including:

• Nonclinical summaries
• Clinical modules for all submission application types
• 505(b)1 and 505(b)2 applications
• Diversity plans
• eSTAR 510K submission documents
• Device-focused documents (clinical investigation plans, evaluation reports, risk documentation)
• In vitro diagnostic (IVD) program documentation
• Integrated summaries of efficacy and safety
• Applications for specialized populations and drug designations
• Study design/synopsis development  and protocols including amendments
• Creation of global study ICF templates
• Plain language protocol synopses and summaries of results
• Investigator brochures
• Clinical study reports (CSRs)
• MAA, CEs, and other international submissions
• Pediatric Investigation Plans, Breakthrough, and Fast-Track Designation documentation
• Pharmacy manuals
• Charters
• Safety reports
• Data presentations (posters, manuscripts, white papers, advisory board materials)
• Registration, updates, and results for public registries like ClinicalTrials.gov

Let’s Get Started

When you engage with Premier Research medical writers, you can count on timely, high-quality deliverables from a team recognized for exemplary work and extraordinary levels of customer satisfaction. Contact Premier today to discuss your program.