About Lachman Consultant Services
Lachman Consultant Services is a leading provider of FDA compliance consulting, regulatory affairs, due diligence audits, and technical services for global clients. With over 40 years of experience in the industry, Lachman Consultants has established itself as a trusted partner to pharmaceutical, biotechnology, medical device and dietary supplement companies worldwide.
The company's team of experts includes former FDA officials and industry professionals who have extensive knowledge and experience in navigating the complex regulatory landscape. They work closely with clients to ensure that their products meet all applicable regulations and standards while also helping them to optimize their operations for maximum efficiency.
One of the key areas where Lachman Consultants excels is in providing FDA compliance consulting services. The company offers a wide range of services designed to help clients navigate the complex regulatory environment surrounding pharmaceuticals, biologics, medical devices and dietary supplements. These include pre-approval inspections (PAIs), post-approval inspections (PAIs), GMP audits, quality system assessments (QSAs), remediation planning and implementation support.
In addition to its FDA compliance consulting services, Lachman Consultants also provides regulatory affairs support to help clients obtain product approvals from regulatory agencies around the world. This includes assistance with preparing submissions for INDs/NDAs/BLAs/ANDAs/510(k)s/PMA applications as well as managing interactions with regulators during review processes.
Another area where Lachman Consultants excels is in conducting due diligence audits for mergers & acquisitions (M&A) transactions involving life sciences companies. The company's team has extensive experience in conducting comprehensive assessments of target companies' operations including manufacturing facilities, quality systems & controls as well as intellectual property portfolios.
Lachman Consultant Services also provides technical services such as process development & optimization support; analytical method development & validation; stability studies; formulation development; technology transfer support among others.
Overall,Lachman Consultant Services is an excellent choice for any life sciences company looking for expert guidance on navigating the complex world of FDA regulations or seeking assistance with M&A transactions or technical challenges related to product development or manufacturing processes.Their team's expertise combined with their commitment towards delivering high-quality results makes them stand out from other competitors in this space.