Medicom Consulting

Medicom Consulting provides professional support in quality and regulatory affairs management to the Medical Device, Diagnostic, Biological, and Pharmaceutical Industry. Our support services are designed to help companies to improve compliance levels with US, EU and other national regulations, thereby improving product quality, safety and effectiveness, and avoiding difficult financial and reputational problems associated with adverse regulatory inspections.

Our goal is to assist you attain operational excellence.

Since Medicom Consulting was established in 1995, by Tom Donnelly and Ron Pagan the partnership along with carefully selected associates, has allowed a full range of support services to be provided to more than 150 companies internationally. Our success allows us to enjoy repeat business from our client base, coupled with strong referral recommendations due to our reliable and accurate service provision.

We have assisted many clients in increasing profitability, and improving relationships with FDA, EU Notified Bodies and Competent Authorities, by ensuring compliance with various Quality System Standards including the GMP's. Examples include the removal of FDA imposed Import Alerts and the successful GMP Certification of companies deemed recidivist by FDA, resulting in such companies being able to return to the US market, from which they were excluded following an adverse FDA inspection

• Compliance Auditing

• Personnel Training

• Consultancy and Project Management.