Lachman Consultants: The One-Stop-Shop for Compliance and Regulatory Requirements
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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).
Apart from this, the group also advises on a full range of regulatory and scientific issues related to generics and new drugs, provides regulatory and quality support related to medical devices and drug-device combinations, prepares FDA meeting requests and requisite briefing packages, to name a few.
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
Lastly, Lachman Consultants’ Science and Technology Practice group works in collaboration with the Compliance and Regulatory Affairs Practices teams to efficiently and effectively address regulatory issues with a thorough and balanced approach. The Science and Technology Practice group holds a comprehensive understanding of the technical challenges that clients often come across to address diverse compliance issues. This allows them to recommend solutions that are scientifically and/or technically accurate and eminently actionable within clients’ operations. The Science and Technology Practice group is responsible for developing comprehensive quality control laboratory training and qualification courses, providing expert scientific guidance to understand and resolve significant issues related to adverse FDA 483 observations and warning letters, and many others. “In one way or another, the Science and Technology Practice group’s work touches every client,” elucidates Ricki A. Chase, Executive Director, Lachman Consultants.
Bringing Innovation as a Full-Service Consultancy
All the consultants working as a part of the three practice groups hold at least ten years of experience in the industry or regulatory agencies and extensive knowledge of working across multiple geographies as well as diverse regulatory landscapes. As such, Lachman Consultants can select the right professional for the right project. “We understand the difference between a specialist and a generalist as well as an auditor and a remediator. Unfortunately, businesses often strive to mechanically address the law or regulations. Lachman Consultants not only helps clients follow the regulations, but we help them do it in a sustainable manner,” Linda mentions. This involves the development of critical thinking and planning skills for addressing compliance requirements and achieving business success. “No matter what the time or date is, our employees are always ready to solve our clients’ problems,” she prides.
Utilizing such an extensive experience of their team across different markets and regulatory requirements, Lachman Consultants brings a global perspective to the changing medical device marketplace and operate as a full-service consultancy. Meaning, the company can work with clients throughout the product lifecycle, including R & D, product submission, the establishment of a novel quality system for post-market surveillance, and a holistic data governance process.
This allows clients to work collaboratively with one partner that lessens the administrative work associated with large projects. “Unlike our competitors who specialize in only one practice (regulatory or compliance or science/technology), we have the expertise to guide a client from the earliest stages of design to the regulatory submission. This proactive approach ensures medical devices’ intended use and safety profile,” Ricki elucidates.
“No matter what the time or date is, our employees are always ready to solve our clients’ problems”
The company also believes in continuously expanding its service portfolio to always help their clients seamlessly overcome compliance hurdles. For example, in the last few years, products like auto-injectors, pre-filled syringes, and patch delivery systems are breaking new grounds due to their advanced therapeutic and diagnostic characteristics. As such, Lachman Consultants today has started to offer compliance guidance (harmonization of drug/biologic device development, quality systems audit to 21 CFR Part 4, to name a few). In addition to this, Lachman Consultants is helping its clients be compliant with both the FDA regulations and ISO 13485 standards, acknowledging the FDA’s intention to harmonize its Quality System Regulation with ISO 13485 amid the globalization of medical devices.
Also, while other consulting companies have been continually moving in and out of the regulatory compliance landscape, Lachman Consultants stayed true to its core offering since its inception and have evolved according to clients’ business requirements. For example, with the generic drug industry coming into the combination products arena, the company is helping several generic drug manufacturers in Asia and Eastern Europe to enter the U.S. market and capitalize on the considerable growth potential.
Having worked with several entities, the company never fails to acknowledge that every client has different regulatory requirements. This drives Lachman Consultants to understand their clients’ unique challenges and assess gaps in their processes for channelizing their expertise in the right way. “Over the years, we have gained a comprehensive knowledge of the regulatory nuances. We leverage it to enable our clients to jump through complex regulatory hoops,” says Mary D. Oates, Vice President of Compliance Services at Lachman Consultants.
This dedication to serving clients and help them mitigate compliance challenges has enabled Lachman Consultants to grow exponentially over the years and diversify its client base across multiple continents where medical device and combination device manufacturing have proliferated. The company has recently set footprints in Lucerne, Switzerland, Dublin, and Ireland to strengthen its global presence. Striding ahead, Lachman Consultants is looking to focus on advanced medical devices and technologies.
“Today, we are the go-to partner for both established entities and startups to address the regulatory requirements. Going forward, we will continue pursuing our mission to help our clients release products in the market faster and navigate the ever changing and challenging regulations,” concludes Mary.