The growing complexity of medical devices has impelled regulatory authorities across the globe to redefine the age-old approval process and post-marketing surveillance. In fact, the FDA has recently brought changes in its Quality System Regulation (in draft scheduled to be presented in October 2020), alongside the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) regulations— from the European Union—for determining new and better ways to manage the growth in this arena. Although such regulations have bolstered the safety aspects of medical devices, they have presented a particularly challenging situation for the manufacturers. Meeting or exceeding these new standards alongside the existing ones, throughout the product lifecycle (design/development/ testing, manufacturing, packaging, and labeling), has become a significant challenge. To this end, it is essential for medical device manufacturers to collaborate with expert consultants for resolving stringent compliance-related issues and developing efficient, effective strategies for the submission and approval of devices.

New York-based Lachman Consultant Services (Lachman Consultants) has moved the needle in the medical device manufacturing space by providing expert technical and regulatory consulting services to pharmaceutical, biotechnology, biologics, medical device, and life sciences companies across different geographies. “Over the last four decades, we have been helping these sectors in many ways, such as preparing and responding to inspections, filing applications, remediating unforeseen challenges, and proactively building systems to address the regulatory requirements,” states Linda Evans O’Connor, VP and Chief of Staff, Lachman Consultants.

Three Practice Groups for Providing a Holistic Service

Lachman Consultants offers its service through three practice groups. The first one or the Compliance group comprises a team of experts from the FDA and the medical device industry. It works collaboratively with medical device manufacturers to design and implement effective and efficient business processes that ensure sustainable compliance through optimal integration of scientific, technical, and regulatory principles. The group performs third-party oversight for single-site and multi-site consent decree remediation, provides expert consultant services for the development and execution of numerous FDA-accepted remediation/voluntary corrective action plans, and many others. It also provides numerous due diligence activities during the pre-purchase phase for multinational companies and marketing applications and performs specialized audits and consultations under attorney-client privilege.

The second group, Regulatory Affairs Practice, encompasses former senior-level FDA managers, FDA reviewers, and experts to bring simple, workable solutions to clients’ regulatory problems or issues. This group has earned a stellar reputation to consistently produce high-quality documents that help clients meet regulatory standards quickly and efficiently. A key operation of the Regulatory Affairs Practice group is the preparation, submission, as well as management of Electronic Common Technical Documents (eCTD) of Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs) (505(b)(2) and 505(b)(1)), and Drug Master File (DMFs).