Market access challenges
Regulatory documentation market access. In addition to having a medical product that is safe, effective, and meets a medical need, manufacturers must traverse regulatory pathways and requirements to be able to sell their products in a given market geography. Key among them are design and testing information, and a well-written regulatory submission.
Product testing
The first requirement for regulatory documentation is product testing in accordance with recognized standards and guidance. This includes related test protocols, test documentation, and reports that are clear, accurate, and complete. If you are not sure whether your documentation is sufficient, contact us and we can review your documentation to identify any gaps that may need to be filled before preparing a regulatory submission.
Regulatory documentation
With a solid base of technical documentation, our regulatory specialists will prepare a regulatory submission that is organized, well written, complete, and meets the regulatory requirements of the agency that will evaluate the product.
Documentation examples
Some examples of regulatory documentation that Medical Devices and Pharma will expertly prepare for you are:
- Premarket notification (510(k)) submissions
- Premarket approval (PMA) modules and submissions
- PMA supplements
- De Novo submissions
- Q-sub meeting documentation
- Investigational device exemption (IDE) applications and amendments
- Summary of technical documentation (STED) file
- Design dossiers
- Technical files
- Postmarket surveillance documentation
- EU change notifications and supplements, and
- Annual reports
Contact us
We offer personalized, professional service to get your product to market in the most economical, effective, and expeditious way possible. Contact us today to discuss regulatory needs for your next project.
