Our Expert Regulatory Scientists will pave a way forward to approval.

We help your business succeed by working to streamline the pharma regulatory process. DemeTECH's experienced regulatory consulting and FDA compliance team commands an unparalleled breadth and depth of knowledge of the FDA and EMA regulatory frameworks and can work with you to accomplish your business objectives. We develop detailed strategies for your product, providing a clear path through all the critical milestones to achieve a successful outcome. We can also help with your post-authorization regulatory pharma needs, including launching your product, line extensions (LE), and variations and maintaining your product's optimal regulatory status throughout its life cycle.

Regulatory Framework

FDA 510(K) SUBMISSIONS

We help with premarket submission to demonstrate that your device is safe and effective to bring to market.

ISO/CE/MDSAP

We help ensure your products meet National and International Standards in all applicable markets.

INVESTIGATIONAL DEVICE EXEMPTION (IDE)

We can collect safety and effectiveness data to support a PMA application or Premarket Notification submission.

QUALITY SYSTEM REGULATION

We undergo FDA inspections to ensure compliance with the QS requirements for designing, purchasing, manufacturing, packaging, labeling, and storing all devices we manufacture.