Medical Device Regulatory Approval Program
Regulatory approval and FDA clearance for any new Medical Device is a two-part program involving both Analytical Support and Regulatory Guidance. Impact Analytical through our partnership with E.M.M.A. International can provide a one stop service for our clients to aid in getting your products to market sooner.
Our experts assist our clients by helping to define their regulatory strategy, reviewing their 510 (k) submissions for compliance gaps and developing an analytical testing plan to provide the most complete submission possible.
Impact Analytical is a GLP-compliant, cGMP-registered, DEA-licensed, and ISO 9001:2015-certified laboratory. Our FDA and EPA facility audits, to date, have resulted in no major or minor findings. The combination of our certifications, robust quality program, experience, and technical expertise make us exceptionally qualified to execute regulated studies. We are able to comply with FDA, EPA, REACH, and OECD guidelines. All of our instrumentation is qualified under cGMP requirements and every analyst receives annual regulatory training. Whether you are in the initial stages, have a protocol or method for us to follow, or need a method validated, Impact Analytical investigators work with our customers quality assurance unit and Impact Analytical has now partnered with the E.M.M.A. International Consulting Group, Inc. to offer testing guidance for regulatory submissions, validations and more.
E.M.M.A. International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Farmington Hills, MI, as well as offices in FL & PA. E.M.M.A.’s focus is on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries as well as EPA submission. This partnership allows us to accelerate the regulatory approval process by streamlining the analytical data exchange behind the compliance process. For most customers, this could ultimately translate into lower costs too. To discuss how Impact Analytical and E.M.M.A. International can help your regulatory process please contact us or for more information, visit our quality section.
Examples of FDA and EPA regulated studies we’ve performed in the past include:
- Test substance characterization
- API quantitation
- Method validation
- Method transfer
- Stability studies
- Impurity characterization
- Clinical Release testing
- Material compatibility studies
Adding Value by Integrating cGMP with an ISO 9000 Quality Management System
By John MacLauchlan, Quality Systems, Impact Analytical
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