Regulatory Initiatives and Activities
Lachman Consultants provides a wide range of support for diverse regulatory initiatives and activities. We are frequently called upon to represent clients with the FDA and other regulatory bodies, and to help clients prepare or correct regulatory filings. When you need industry-leading support, leverage our extensive experience:
- Communicating with regulatory agencies
- Act as FDA liaison for international and domestic clients
- Preparing ANDAs, NDAs, DMFs, and other regulatory applications
- Reviewing advertising and promotional materials
- Assisting with drug listings
- Preparing FDA meeting requests and requisite briefing packages
- Performing on-site regulatory assistance
- Preparing standard operating procedures
- Delivering on-site training on regulatory topics
- Attending professional and advisory committee meetings on our clients' behalf
