Experience. Excellence.
Through our long-standing mastery of technical and regulatory consultation services, Lachman Consultants serves all areas of FDA-related activities for the Pharmaceutical, Biotechnology, Biologics, Diagnostic, Device and Allied Health Industries.
We serve a diverse base of loyal clients around the globe, from emerging-to-enterprise organizations across virtually any specialty of the life sciences.
The associates of Lachman Consultants are proficient in the development, implementation and management of diversified projects involving scientific principles, technical aspects and regulatory requirements.
More than Forty Years of Achievement.
Advance. Confidently.
Since 1978, we have furnished expert compliance, regulatory affairs and technical services to clients around the world, helping avoid and resolve compliance problems, and assisting in the development of efficient and effective strategies for the submission and approval of drugs and devices.
Lachman Consultants has set the industry standard through:
Senior Consultants.
Lachman’s team includes highly accomplished consultants who have a solid knowledge base, strong connections, and wisdom that can only come from decades of industry experience.
Efficient Engagements.
Lachman’s consultants solve problems the first time – helping to ensure that you achieve desired outcomes quickly and more efficiently.
Integrated Expertise.
Lachman’s three practice groups collaborate extensively, ensuring that problems entrusted to us are addressed from all possible angles.
Loyal Clients.
Lachman consistently delivers thoughtful, effective solutions, which is why clients repeatedly turn to us and refer others for help with their most challenging compliance and regulatory issues.
As long-standing leaders in technical and regulatory consultation services, Lachman Consultants’ clients experience excellence provided by an unmatched team of respected industry professionals and SMEs.
PHARMACEUTICAL
Lachman Consultants has an unsurpassed reputation for excellence in technical, regulatory consultation, and guidance services for the Pharmaceutical Industry, including generic and novel drug products, OTC, and monograph drugs, and many more.
MEDICAL DEVICE/COMBINATION PRODUCTS
Lachman Consultants’ comprehensive list of services extends to all classes of medical devices and combination products including In Vitro Diagnostics, Integral, Cross-labeled and Kitted Combination Products.
BIOLOGICS
Lachman Consultants has a reputation for demonstrated excellence in technical, regulatory consulting, and guidance services for biologics, including cell and gene therapy, human cell and tissue products, monoclonal antibodies, biosimilars and many more.
REGULATORY AFFAIRS
Lachman Consultants’ Regulatory Affairs group is comprised of former senior-level FDA managers, FDA reviewers, and industry experts. Their goal is simple; provide simple workable solutions for client’s regulatory problems or issues at the highest levels of efficiency and excellence.The Lachman Consultants Management Team
Trusted. Experts.
Lachman Consultant’s multi-disciplinary team of FDA and industry experts offers a full-range of compliance, regulatory affairs and technical services to clients around the globe.
Global Solutions & Services
Lachman Consultants serves a diverse base of global and loyal clients ranging in size from one-person startups to multinational corporations. Lachman Consultants consistently produces high-quality results for clients regardless of size, geography, or specialty, including:
- The world’s largest pharmaceutical companies
- Medical device companies
- Biotechnology companies
- Emerging pharmaceutical companies
- Dietary supplement companies
- Law firms that serve pharmaceutical, biotechnology, medical device and/or dietary supplement companies
- Investment firms handling mergers and acquisitions on behalf of pharmaceutical, biotechnology, medical device and/or dietary supplement companies
MISSION STATEMENT
Lachman Consultant Services delivers the highest quality FDA compliance and regulatory consulting services to the pharmaceutical, medical device, biopharmaceutical, and related industries.
Our mission embodies the following strategic factors:
- Apply our expertise and experience to enhance the global availability of products that benefit mankind by continually improving our versatility, knowledge, and capacity to support client success.
- Continually work to position the firm as the leading full-service provider to the global pharmaceutical and related industries in support of the development, regulatory approval, production, control, marketing and surveillance of pharmaceutical drugs, biotechnology-derived products, medical devices, veterinary products, dietary supplements and cosmetics.
- Foster a culture that values professionalism and expertise, and our competencies of integrity, innovation, team collaboration, and passion for our business and the world around us.
- Be the premier consulting resource, based on our record of consistently providing high-quality services that foster best business practices and consistently deliver timely, innovative, practical and cost-effective regulatory compliance solutions.
- Provide high business value, based on a clear vision, sound management, effective operating processes, and technologies that are aligned with work needs, and the collaboration of a team that is highly qualified, talented and motivated.
FDA Manufacturing Compliance And Inspections For Cell And Gene Therapies and Other Innovative Biologics
