We establish regulatory training programs to educate internal units of major medical device and combination product companies about adverse event reporting requirements and procedures.
We have assisted clients in responding to enforcement actions related to inadequate adverse event reporting and helped develop procedures to protect against future enforcement.
Helped clients conduct retrospective reviews of their files to assess their obligations in submitting Medical Device Reports to the FDA and bring their reporting up to date.
Band 1 for Healthcare and Healthcare: Pharmaceuticals/ Medical Products - District of Columbia
Chambers USA
Regulatory Firm of the Year
LMG Life Sciences Awards
Highly Recommended for FDA Medical Devices
LMG Life Sciences
