Regulatory Medical Writing

At Orphan Drug Services Inc., we are dedicated to advancing the development and approval of orphan drugs to treat rare diseases. Our expert team specializes in regulatory medical writing and regulatory submission, guiding pharmaceutical companies through the intricate process of regulatory strategy and documentation.

Get in touch with us to learn more about regulatory medical writing in New York.

Our team crafts detailed clinical trial protocols that are essential for both the ethical and scientific integrity of your planned clinical research. We ensure that each protocol clearly outlines the objective, design, methodology, statistical considerations, and organization of a clinical trial critical for obtaining regulatory approval.

We produce investigator brochures that go beyond mere compliance. Our regulatory medical writing expertise ensures these documents communicate a thorough understanding of the investigational product, ensuring investigators are well informed, which is pivotal for the safe and efficacious conduct of clinical studies.

Navigating through the preparation of Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Applications (aNDA), and Supplemental New Drug Applications (sNDA) is one of our core strengths. We understand the complexities and nuances involved in each type of application, ensuring a smooth regulatory submission process.

Orphan Drug Services Inc. provides strategic regulatory solutions to maximize your product’s potential to receive ODA designation. Our seasoned team ensures that your submission meets all specific requirements set forth by the regulatory authorities, facilitating faster approval and market entry.

Effective communication with regulatory bodies begins with well-prepared meeting requests. Our regulatory submission services include the creation and submission of these requests, which are fundamental for the productive advancement of your drug development agenda.

Our service includes the preparation of comprehensive meeting request packets that provide the necessary documentation to facilitate productive discussions during regulatory meetings. From pre-IND meetings to end-of-phase discussions, we ensure your data is organized and persuasive.

With a deep understanding of statistical principles, our experts develop clear and detailed statistical analysis plans that outline the methodology for analyzing the primary and secondary data from clinical studies, ensuring the robustness and reliability of your study results.

We produce precise and detailed clinical study reports that document the results and conclusions of your clinical trials. By integrating regulatory medical writing expertise with data analysis acumen, our CSRs document and present findings in a format consistent with regulatory expectations, supporting the credibility and success of your regulatory submission.

Our team creates pharmacy manuals that provide essential information on the handling, storage, and preparation of investigational drugs. They’re tailored to meet specific trial and regulatory needs and are indispensable for ensuring standardization and compliance across study sites.