If you are unsure of the steps to follow during the regulatory affairs process, if you want to ensure your application is perfectly ready for submission, or if you are unfamiliar with what to do after authoring the sections for your Common Technical Document (CTD), we offer a range of services for Submission Preparation Support to assure your application is well-prepared, compliant, accurate, and positioned for successful review by regulatory authorities.
What can we do for you?
Since 2014, we have formatted thousands of documents for clients in different regions across the globe. Document submissions and our other services were primarily for the EU and US regions, and have also been successfully completed for Canada, Australia, Switzerland, and Great Britain.
To ensure we provide the most up-to-date services, we use the most current guidelines and constantly monitor updates using our internal Regulatory Intelligence system. Regularly, we check vital websites and guidelines, such as:
- for eCTD (https://www.ich.org/page/electronic-standards-estri),
- or more eCTD region specific (https://esubmission.ema.europa.eu/),
- and also related to formatting (ICH guideline M4 (R4) on common technical document (CTD) for the registration of pharmaceuticals for human use – organization of CTD).
Our range of services include, and are not limited to:
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Approach & Expertise
Learn how we can support you in meeting your business goals
- Our approach focuses on a thorough assessment at the start to understand your specific regulatory affairs requirements. With our in-house expertise in numerous process components of Submission Preparation Support, we customize our services to meet your objectives.
- Our versatile, highly skilled team has experience ranging from document formatting to eCTD submission publishing. Our versatility enables us to adapt easily to a new environment or working tools, such as for example, your company formatting style and standards. If your tools or procedures are complex, our team has the experience and flexibility to navigate them.