Regulatory Affairs Practice
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 guidance on marketing of unapproved drug products
- Support submission for OTC and New Dietary Ingredient Notification (NDIN) related issues
Lachman Consultants’ Compliance Practice offers a wide range of mission-critical services to the regulated industry.
Lachman Consultants’ Regulatory Affairs Practice brings simple, workable solutions to clients’ regulatory problems or issues.
Science & Technology
Lachman Consultant’s Science and Technology Practice provides an intimate understanding of the complex scientific and technical challenges clients face and is able to provide recommended solutions that are scientifically and/or technically accurate.