Together Trial with EDC Database Designed by MMS Wins Trial of the Year

Proven pharmaceutical industry consultants

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One of the main challenges lies within the demarcation between medical devices and medicines. It is for the manufacturer to initially determine the classification regarding with regards to the primary function of a combination product. FDA and EMA guidance documents include definitions, and examples as well as laying out regulatory provisions for the manufacturer.

Secondly, depending on the regulatory pathway, various regulatory requirements need to be fulfilled for each component of the drug device combination with respect to preclinical testing, clinical investigation, manufacturing and quality control, adverse event reporting, promotion, advertising, and post approval changes.

Lastly, regional differences in regulatory requirements of combination products add another layer of complexity for product developers planning to launch combination products in multiple regions. These regional differences are yet unharmonized despite a few existing initiatives. As a whole, manufacturers in combination product space need good understanding and appreciation of regional regulatory considerations for successful submissions.

Global experts at MMS support all major submission types.

• Pre-clinical support, including request for application numbers, filing intent to submit applications, meeting requests and briefing packages, and developing submission content plans.
• Clinical development and global submissions of study authorization applications, including initial trial applications and amendments, scientific advice submissions, special designation submissions like fast-track designation, and special protocol assessment requests etc.
• Submission management of marketing authorization applications, responses to requests for information, and post-approval life-cycle management and supplements, Advertisement Promotion, and SPL submissions.

We are excited to share our latest thinking with you.