Regulatory Affairs

Lachman Consultants’ Regulatory Affairs Practice is comprised of former senior-level FDA managers, FDA reviewers, and industry experts. The Regulatory Affairs Practice’s goal is to bring simple, workable solutions to clients’ regulatory problems or issues and has earned a stellar reputation for doing just that. Lachman Consultants consistently produces high-quality documents that move pharmaceutical companies and other client types to the desired outcome more quickly and efficiently.

The Regulatory Affairs Practice Services and Features:

• Prepare and submit eCTD documents of ANDAs and NDAs (505(b)(2) and 505(b)(1)) and DMFs (Type II, III, IV) to regulatory agencies
• Support life cycle management of NDAs, ANDAs and DMFs including submission of amendments, supplements, annual reports, PADERs and other regulatory documents
• Advise on a full range of regulatory compliance and scientific issues related to generics (including complex generics) and new drugs
• Facilitate the timely approval of ANDAs and NDAs based on gap analysis and support with risk mitigation
• Provide consulting services including regulatory strategy and quality support related to device as well as drug device combinations
• Prepare FDA meeting requests and requisite briefing packages for PDUFA and GDUFA meetings and support with FDA meetings
• Act as U.S. Agents for non-U.S. companies while providing global regulatory expertise.
• Provide support with drug listing, facility registration, and guidance on meeting GDUFA or PDUFA requirements
• Perform due diligence audits of applications in association with the buying or selling of pharmaceutical and medical device companies
• Provide support with justifying impurities and excipients related to ANDA and NDA submissions
• Evaluate and provide regulatory consulting on marketing of unapproved drug products
• Support submission for OTC and New Dietary Ingredient Notification (NDIN) related issues