FDA Compliance

One of the original and continuing talents the group that has matured well in the light of the more demanding regulatory environment of the nineties, is the ability to provide objective, third party auditing and consultation to large and small pharmaceutical, biotech, and medical device firms. Group members maintain an excellent relationship with the FDA and Ministries of Health in many parts of the world and can form auditing teams rapidly. The teams have established or brought into US FDA GMP compliance over 200 facilities worldwide, 27 of which included FDA investigators (Only one 483 was issued, but is was Observed/corrected/verified by the end of the audit). We provide customized GMP training on site from entry level to training your auditing staff. We can now support you or your suppliers from training and initial auditing through certification, including the CE mark. Audits have been performed in the past around the globe, most recently in Japan, China, India, Pakistan and Mexico. Senior Principals have experience in GMP, GLP, and GCP audits including;

* API and finished dosage forms audits for cGMP.
 
* GLP audits of academic testing laboratories for implantable cardiac devices.
 
* GCP audits and clinical monitoring for NIH sponsored studies.
 
* QSR and ISO 9000 audits for medical device companies.

Regulatory Services
We have filed both drug and device submissions with the FDA including; NDA, IND, PMA, IDE, HDE, 510(k), gained HUD designation status and filed compliance documents to lift detentions. McCoy Enterprises LLC. quickly assembles a project team that has experience related to the specific areas of product development that are of interest to your company.