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Clinical Regulatory Medical Writing Services

Clinical Regulatory Medical Writing Services

Contact Us

At Syner-G, we specialize in providing comprehensive clinical regulatory medical writing services designed to streamline your drug development process and ensure compliance with global regulatory standards. Our team of experienced medical writers and regulatory experts are dedicated to delivering high-quality regulatory documents that support your clinical research and regulatory submission needs.

Expertise You Can Rely On

Navigating the complexities of clinical trial documentation requires precision, thoroughness, and an in-depth understanding of regulatory requirements. At Syner-G, our medical writers bring extensive experience in clinical research and a detailed knowledge of the regulatory landscape. This unique combination allows us to produce well-crafted, compliant, and persuasive documents tailored to the needs of regulatory bodies like the FDA, EMA, and others.

Our Clinical Regulatory Medical Writing Services Include:

Clinical Study Protocols

Creation of detailed protocols that clearly describe your study objectives, design, methodology, statistical considerations, and compliance with regulatory requirements.

Patient Informed Consent Forms

Drafting of clear and understandable informed consent forms to ensure that study participants are fully informed about the study they are participating in.

Clinical Study
Reports (CSRs)

Comprehensive reports that present the results of your clinical trials in a clear, concise, and scientifically accurate manner, adhering to ICH guidelines and regulatory requirements.

Investigator Brochure(s)

Development of up-to-date, comprehensive documents that provide clinical and preclinical data to support the safe and effective conduct of clinical trials.

Regulatory Submission Documents

Preparation of precise documentation required for INDs, NDAs and BLAs, MAAs, and other regulatory filings. Our documents are crafted to meet the specific requirements of each regulatory authority.

Our medical writers can integrate seamlessly into your product teams to provide support for a wide variety of regulatory documents, including briefing packages for agency meetings; orphan drug, fast track, and breakthrough therapy designation requests; safety narratives; and development safety update reports.

Tailored Approach to Meet Your Needs

At Syner-G, we understand that each project is unique. We collaborate closely with our clients to understand their specific requirements and objectives. This tailored approach ensures that all documents are not only compliant with regulatory standards but also customized to support the specific needs of our clients’ clinical programs and corporate goals.

Quality and Compliance at the Forefront

Quality control is integral to our operational model. We implement rigorous quality control processes at every stage of the document creation process to ensure that all deliverables meet the highest standards of scientific accuracy and regulatory compliance. Our quality checks include full reviews of each document against the sources (protocols; statistical analysis plans; and tables, listings, and figures).

Strategic and Tactical Planning

The regulatory environment is marked by its demand for high standards and rapid innovation. Our team excels in strategic planning and tactical execution, helping to navigate through complex regulatory requirements with ease. Whether it’s adapting to new testing and controls, or optimizing processes for expedited pathways, our plans are designed to keep your project on track for timely development and approval.

Customized Solutions

Every client and project presents unique challenges. At Syner-G, we understand that one size does not fit all when it comes to drug development. We customize our strategies to align perfectly with your specific project requirements, patient population, formulation specifics, and stage of development, ensuring that every aspect of your drug development needs are comprehensively addressed.

Why Choose Syner-G

Expert Team: Our medical writers are well-versed in the specific requirements of regulatory agencies. They possess the scientific understanding necessary to present complex information clearly and persuasively. Our team includes subject matter experts who review content for scientific accuracy and relevance, ensuring that your documents reflect the latest in scientific knowledge and research.

Comprehensive Support: We offer a full suite of writing services covering every aspect of the clinical trial and regulatory submission process. Whether you are at the initial stages of drafting your clinical study protocols or in the final phases of preparing your CSRs, Syner-G is here to support you.

Global Compliance: With a deep understanding of regulatory requirements, our documents are designed to be globally compliant, facilitating a smoother submission process worldwide.

Timely Delivery: We are committed to meeting your timelines, recognizing the importance of speed-to-market in the pharmaceutical industry. Our efficient processes and expert team ensure that your critical documents are delivered on time.

Contact us today

Explore how Syner-G’s clinical regulatory medical writing services can advance your drug development goals. Contact us today to schedule a consultation and learn more about how we can assist you in achieving successful regulatory submissions.