Acorn Regulatory Offers EU Programs for U.S. Drug-Device Sponsors

Acorn Regulatory, an ISO-certified medical device and pharmaceutical consulting firm, has customized programs to help  U.S. manufacturers of drug-device combinations in meeting European regulatory approvals. Focusing on small to mid-size companies, Acorn Regulatory has put in place a comprehensive step-by-step process that provides the correct regulatory pathway for medical device products that also have a drug component.  This process includes training programs that first define the requirements, the steps to obtain CE Mark Certification, post-market responsibilities of manufacturers, national requirements throughout Europe and service as an EU Authorized Representative.