Create the Right Development Story for Approval Success
The success of any regulatory application depends on the quality of its documentation. Each document must present complex data in a clear, concise, and comprehensive way, while remaining fully compliant with the standards and expectations of the European Medicines Agency (EMA) and national agencies. Errors or omissions in submission documentation can result in costly delays or clarification requests that may complicate or even jeopardize the application process.
At ProPharma Group, our medical and technical writing experts have a thorough understanding of the unique organization and expectations for each document type — we know how and where to get the right information, how changes affect every aspect of the process, and how it all fits together. We leverage our vast knowledge of a wide range of products including their benefit to patients, competitive differentiators, and the data required to support key claims to incorporate the most appropriate data, from the most relevant source, at the right place in the document to position your product for approval success.
Scientific Expertise Across All Areas
Our medical and technical writers possess two qualities that together are rare among other regulatory consulting services:
- We have a deeply rooted scientific background – many of our experts are MDs and/or PhDs
- We know the required documentation forward and backward – for more than 30 years, we have assisted clients with hundreds of successful submissions, giving us the opportunity to learn the regulations like the back of our hands
We’ll lead you through every step of the submission process. Our project timelines include thorough reviews and preparation to ensure all potential issues are identified and appropriately addressed, allowing you to submit regulatory applications with complete confidence.
As your trusted medical and technical writing partner, we can assist with your investigational medicinal product dossier (IMPD) and marketing authorization application (MAA) submissions by reviewing and/or authoring the following:
- IMPD and Investigator’s Brochure (IB) submissions
- Preclinical and clinical study protocols
- Module 2, including Quality Overall Summary, Nonclinical Overview and Summary, and Clinical Overview and Summary
- Module 3 Quality, including Drug Substance and Product sections
- Modules 4 and 5
- Risk Management Plans (RMP)
- Environmental Risk Assessment (ERA) for GMOs