Quality Risk Management ICH Q9 – Revision published for public comments
Connecticut‐based Pharmaceutical Regulatory Affairs service provider, PharmaLex US, announced today that it has entered into a cooperative agreement with H. L. Dorfman Pharmaceutical Consulting, LLC. This strategic alignment now provides clients with a full service portfolio of regulatory strategy and operations, FDA meeting preparation, healthcare compliance, and risk management services involving the pharmaceutical, medical device and biotech industries.
Howard Dorfman of H. L. Dorfman Pharmaceutical Consulting has been a resource to the pharmaceutical, biotech and medical device industries for over 30 years, focusing on identifying and addressing issues affecting these industries. Howard is experienced in such areas as creating company compliance programs, internal training, negotiating Corporate Integrity Agreements and reporting processes, management of multi-jurisdiction and individual litigation (including qui tam, product liability and advertising). He also offers expertise in establishing processes and procedures for the review and approval of FDA-compliant advertising and promotion materials. Howard is a member of the New York bar and is admitted to practice before the U.S. Supreme Court.
”I am excited at the opportunity to work closely with PharmaLex, a recognized leader in providing regulatory services to FDA-regulated companies. The breadth of our combined experience can offer the widest range of support services to address the most challenging issues facing the pharmaceutical, biotech and medical device industries, focusing on such critical issues as regulatory procedures, health care compliance and risk management” offered Howard Dorfman.
“We are looking forward to exceeding the expectations of our clients by providing the highest quality of regulatory and related services. Each of our companies brings a tremendous amount of FDA expertise and together we can provide efficient solutions to complex regulatory, risk management and compliance issues” said Eva Keck, Director Business Development Operations.
PharmaLex US, LLC., a U.S. affiliate to PharmaLex GmbH, provides expert guidance to companies seeking assistance with FDA regulatory strategy during all stages of the drug development process. Together, the PharmaLex Group combines local expertise with global reach in the area of Development Consulting & Scientific Affairs, Regulatory Affairs and Pharmacovigilance. They have a proven track record of success in outsourcing programs with more than 25,000 successfully completed projects for more than 500 clients worldwide.
For further information, please contact:
Ms. Eva Keck
PharmaLex GmbH; Director Business Development Operations
eva.keck@pharmalex.com
+49 621 18 15 38 0
Harrlachweg 6; 68163 Mannheim
Germany
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