Medical Writing Services

Syner-G recognizes the critical role of high-quality, regulatory-compliant medical writing services for healthcare and pharmaceutical advancements. Our team of seasoned medical writers excel in producing clear and concise scientifically accurate documents.

Specializing in a broad spectrum of regulatory documents, including clinical study reports, Investigator Brochures, and marketing applications like NDAs and BLAs, Syner-G has contributed to over 50 successful applications. Our commitment to excellence guarantees that each document meets the rigorous standards of scientific and regulatory precision, supporting our clients in bringing new treatments and medical devices to market efficiently and effectively.

Comprehensive Document Preparation Services

Our medical writing expertise encompasses a wide array of document types essential for regulatory submissions and scientific communication. With proficiency in the document development phase, we ensure that each document is crafted with precision, supporting our clients through the drug development process and regulatory approval.

      Our medical writing services include:

      Marketing Applications

      Nonclinical and Clinical Pharmacology Summaries and Overviews

      CSRs (across all phases of development)

      INDs and IND Amendments

      Orphan Drug Applications and Annual Reports

      Investigator Brochures

      Clinical Protocols and Amendments

      Safety Narratives

      Development Safety Update Reports (DSURs)

      IND and NDA Annual Reports

      Regulatory Agency Briefing Documents

      Advisory Committee Briefing Packages

      Pediatric Study Plans (US)

      Pediatric Investigation Plans (PIPs) (EU)

      Medical Communications

      Extensive Experience and Expertise Since 2007

      Our medical writing team, comprised of medical writing experts, distinguishes itself through extensive experience, which spans a wide range of therapeutic areas. Our systematic approach to each task ensures that every document produced is of the highest quality and precision. This depth of knowledge allows us to offer comprehensive support for a variety of regulatory documentation needs, tailored to the specific requirements of each project.

      Therapeutic Areas and Development Phases

      With broad medical writing skills, we are adept at addressing the unique challenges and nuances of each field. Our expertise in clinical research is evident in every document produced, reflecting our commitment to excellence in every phase of development. 

      From early-stage research to late-phase clinical trials, our writers have experience navigating the complexities of drug development. This versatility guarantees that we can provide high-quality, scientifically sound documentation that meets the stringent requirements of regulatory agencies worldwide.

      Variety of Regulatory Documents

      The scope of our work encompasses various regulatory documents, each critical to the success of our clients’ projects:

      • Clinical Study Reports (CSRs): We produce detailed reports that clearly present the findings of clinical studies, meeting global regulatory guidelines.
      • Clinical Protocols: Our team designs comprehensive protocols that outline the objectives, design, methodology, statistical considerations, and organization of clinical trials.
      • Investigator Brochures: We compile essential data on investigational products for use by clinical investigators, ensuring that it is presented clearly and concisely.
      • Investigational New Drug (IND) Applications: Our writers are skilled in preparing the necessary documentation to obtain approval to start clinical trials, including detailed information about the investigational product, its manufacturing, and plans for clinical study.

      Procedures Developed to Maintain the Highest Quality Control

      Our standard operating procedures are in place to ensure all documents undergo thorough quality control and scientific reviews prior to delivery to our clients. We prepare your documents using our suite of ICH-compliant templates and style guide or using sponsor-provided materials. Our team produces high-quality documents with a focus on formatting and style, as well as scientific communications and content.

      Through their commitment to excellence and our extensive experience, Syner-G’s medical writing team makes sure that all documents are crafted to facilitate the smooth progress of drug development programs and support successful regulatory submissions. 

      Following submissions of NDAs and BLAs in the US, we are frequently asked by our clients to assist them in authoring Briefing Documents in support of FDA Advisory Committee Meetings.

      Unmatched Proficiency in Marketing Applications

      Crafting the clinical components essential for marketing applications, including New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs), is a speciality of our medical writing team.

      Authoring Clinical Components

      The preparation of clinical documentation for NDAs, BLAs, and MAAs demands a deep understanding of regulatory requirements and an ability to present complex data in a clear, comprehensive manner. Our team’s proficiency in these areas guarantees each document we produce aligns with the stringent standards set by regulatory agencies in the U.S. and Europe.

      By meticulously detailing the safety, efficacy, and quality of investigational products, we facilitate a smoother review process and enhance the likelihood of approval.

      A Track Record of Success

      Our involvement in authoring portions of more than 50 marketing applications speaks to our significant role in advancing pharmaceutical innovation. This track record not only reflects our capability to produce a high volume of complex regulatory documents but also our consistent success in contributing to the approval of new drugs and therapies.

      Each application we support benefits from our strategic insights and tailored approach, ensuring that the clinical evidence is presented in the most persuasive manner possible.

      Engage Our Expertise

      Syner-G is dedicated to advancing your pharmaceutical projects with our specialized medical writing services. Our experienced medical writers, many with advanced degrees, guarantee quality and are ready to provide the services and support necessary to navigate the complexities of regulatory documentation and submissions. 

      If you are seeking unparalleled precision, clarity, and regulatory insight in your medical writing needs, connect with us. Let’s discuss how we can contribute to the success of your projects and accelerate the journey of your products from development to market. Contact us today to explore our services and start a collaboration that transforms your challenges into achievements.

      Our Fellowship Program

      Our Medical Writing Fellowship Program is for medical writer professionals looking to gain experience in the medical/regulatory writing field. Fellows will be exposed to a variety of regulatory documents related to the clinical development of investigational and marketed drugs and biologics.

      Headquarters

      100 Pennsylvania Avenue, Suite 310
      Framingham, MA 01701

      Contact Us

      508.460.9700
      info@synergbiopharma.com

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