Lachman’s 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 consistently produces high-quality documents that move clients to the desired outcome more quickly and efficiently.
The Regulatory Affairs Practice has consulted with and assisted numerous clients in addressing and overcoming regulatory affairs challenges. The accomplishments below represent a sampling of the results delivered to clients:
- Prepared and submitted ANDAs and NDAs (including eCTDs), and DMFs
- Facilitated the timely approval of ANDAs and NDAs, including first-time generic approvals
- Performed due diligence audits of applications in association with the sale of pharmaceutical companies including a major, global pharmaceutical company
- Evaluated and facilitated the resolution of complex exclusivity issues involving generic and branded products.
- Prepared FDA meeting requests and requisite briefing packages for PDUFA meetings
- Reviewed and provided comprehensive feedback on major advertising campaigns and promotional materials
- Evaluated and provided regulatory guidance on marketing of unapproved drug products
- Facilitated the resolution of drug listing issues and related U.S. Customs’ detention orders
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