Medicom Consulting provides expert support in quality and regulatory affairs management to the Medical Device, Diagnostic, Biological, and Pharmaceutical Industry. Our goal is to assist in the achievement of operational excellence in regulatory compliance with US, EU and other national regulations. Our support services are designed to improve product quality, safety and effectiveness, and avoiding difficult financial and reputational problems associated with adverse regulatory inspections. Many of our support services can be provided remotely as well as onsite.

Medicom Consulting was established in 1995, by Tom Donnelly and Ron Pagan (now retired) the partnership along with carefully selected Subject Matter Experts (SMEs), has allowed a full range of support services to be provided to more than 250 companies internationally. Our success allows us to enjoy repeat business from our client base, coupled with strong referral recommendations due to our beneficial 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. 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 adverse FDA inspections.

The main services which are provided internationally to a diverse range of small and large clients are:

  • Terminal sterilization (Ethylene Oxide (EO), Gamma / eBeam, & Steam)

  • Microbiological controls

  • Material biocompatibility

  • Quality System Remediation following FDA Warning Letter/Consent Decree, & EU Notified Body inspections

  • Implementation of Quality Systems at new location start-ups

We are sure our unique blend of skills and experience can assist your company to meet its regulatory responsibilities and quality improvement objectives both in practical and cost-effective terms.

We welcome the opportunity of working with you and providing a bespoke service to meet your needs.