Lachman Consultant Services, Inc. (Lachman Consultants), recently completed the expansion of our existing operations in Ireland to support the growing demand for services in the European region. Operating under the name Lachman Consultants (Ireland) Limited, this expanded pharmaceutical quality and regulatory consultancy is the most recent development in our global expansion to better serve the needs of our clients and the worldwide life sciences industry.
Lachman Consultants (Ireland) supports the European region with a multidisciplinary team of industry experts with a depth of knowledge and relationships specific to regional and global regulatory landscapes.
Lachman Consultants (Ireland)’s extensive range of client services now include:
A full portfolio of services to help clients stay current and compliant by designing and implementing effective quality systems and business processes to deliver measurable results that prevent and resolve compliance issues.
Effective compliance and regulatory services such as Medical Device Regulation (MDR) guidance, general audits, pre-approval inspection support and data integrity reviews in areas such as cardiology, orthopedics, and in vitro diagnostics as well as combination devices like auto-injectors, patch delivery systems, and pre-filled syringes.
A full range of consulting services that include, harmonization of biologic/device development, quality systems audit, and Pre-Market Approval (PMA) for areas that include medical products, materials and components, processes and mechanical engineering and manufacturing.
Through a dedicated single point of contact, multidisciplinary groups of accomplished industry experts are selected and assigned based on each client’s unique set of objectives, needs, and circumstances that include monoclonal antibodies, growth factors, replacement enzyme therapies, and peptides.
Composed of former senior-level Regulatory Authority managers, reviewers, and industry experts, our consultants provide simple, workable solutions for each client’s regulatory problems or issues at the highest levels of efficiency and excellence. They advise on a full range of regulatory compliance and scientific issues related to generics (including complex generics) and new drugs and the preparation and electronic submission of all types of regulatory documents.
Lachman Consultants (Ireland) Limited is headquartered in Dublin, and led by Senior Director, John Darby, M.Sc.