Matthew Frey Email & Phone Number

Wilmington, Delaware, Us

- Advise worldwide manufacturing quality organization on GMP compliance; health authority inspections, including on-site support; all communications with health authorities, including responses to health authority inspectional observations; investigations into manufacturing deviations; internal audits; quality assurance agreements; and quality oversight of contract manufacturing organizations (CMOs)- Advise Tech Ops organization concerning compliance with laws and regulations related to the development and manufacture of small molecule compounds and products; foreign and domestic trade; anti-counterfeiting; anti-bribery and anti-corruption; and U.S. data privacy- Advise U.S. and Canada investigational and commercial product supply chain organizations- Draft, revise, and negotiate supply, services, confidentiality, and quality agreements with third parties- Member of Compliance Risk Oversight Council - Supervise outside counsel

Basel, Baselstadt, Ch

- Advised worldwide manufacturing quality organization on GMP compliance; health authority inspections, including on-site support; all communications with health authorities, including responses to health authority inspectional observations; investigations into manufacturing deviations;internal audits; and quality assurance agreements- Developed and trained quality personnel on templates and guidance documents designed to streamline compliance with GMP requirements- Advised procurement personnel on various agreements between internal manufacturing sites and third parties- Training coordinator for Operations Legal Team- Member of Operations Legal Leadership Team, Extended Quality Leadership Team, Extended Quality Compliance Leadership Team- Selected and supervise outside counsel

I advised the Merck Manufacturing Division on all issues related to CGMPs for small molecule and vaccine products. I also advised on issues related to Merck's external contract manufacturing network. Previously, I advised the company on all advertising, promotion, and labeling issues for an IV antibiotic, which, following its acquisition, I helped integrate into the company and re-launch; a novel anticoagulant; various adult vaccines; hepatitis C products; anesthesia products; and ophthalmics products. I have also advised the company on federal and state privacy laws and issues related to market research and outcomes research. In addition, I regularly advised on manufacturing-related aspects of company acquisitions and supervise outside counsel.

Charleston, Wv, Us

Commercial litigation attorney.

Philadelphia, Pa, Us

Associate in commercial litigation and products liability practice groups.

J.D., Law

A.M., English

B.A., English

Education record

Education record