Simplifies Complex EU Certification Requirements with Customized Programs
Acorn Regulatory, an ISO-certified medical device and pharmaceutical consulting firm, announces it will be participating in MedInIreland 2016 occurring at the Convention Centre Dublin on 29 October 2015. Acorn will highlight how manufacturers of drug-device combinations are able to streamline procedures through customized programs that successfully overcome the challenges 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 an ancillary drug component. This system includes programs that define the requirements and steps to obtain CE Mark Certification, post-market responsibilities of manufacturers and national requirements throughout Europe as well as services offered as an EU Authorized Representative.
"While our work includes support for large multi-national pharmaceutical and device manufacturers, we have found that, in particular, small- to mid-size companies looking for EU certification are often intimidated by the complex steps and potential costs in gaining approvals," said Dr. Gemma Robinson, Managing Director of Acorn Regulatory. "To meet that need, we have streamlined the approach with an affordable process and a team with a wide range of experiences in different product technologies who can offer a customized approach to gain CE Certification and manage post-approval activities. These offerings range from training to quality management, report writing, risk management, CTD preparation and representative services."
Companies seeking certification for a drug-device combination can face considerable challenges. The manufacturer must compile a comprehensive dossier clearly describing the quality, safety and usefulness of the drug substance itself, and also on the drug as incorporated into the finished device. This can be an added challenge to small and medium sized companies who don't have expertise in both medical device and pharmaceutical regulations.
According to Dr. Robinson, the complexity of the process and the proliferation of drug-device products seeking EU certification is exactly why Acorn Regulatory further streamlined its process. "We have cross-functional teams that can offer both the medical device but also the pharmaceutical know-how to ensure that we can obtain the fastest route to market for our clients’ products. We also have solid working relationships with regulators -- all to preempt potential obstacles that would ordinarily discourage companies from seeking EU certification," she added.