FMD K&L consultants can help you develop an end-to-end approach to global product development that integrates clinical and commercial considerations.
FMD K&L consultants provide expertise covering business strategies as well as clinical, regulatory, operations, technology, and safety considerations. Our diverse team of consultants can assist you in the development of pharmaceuticals, biologics, medical devices, combination products, consumer health products, and cosmetics.
Highly seasoned professionals comprise our consulting team, and offer exceptional academic credentials and solid industry experience. The team is integrated cross-functionally with all groups within FMD K&L, enabling them to draw on an exceptional depth and breadth of resources, enabling them to produce best-in-class recommendations for the most complex challenges.
- Strategic consulting to minimize risk and maximize return on investment
- Global project management
- Audit preparedness
- Due diligence
- Market intelligence
- Regulatory affairs consulting, including review of protocols, informed consent forms, reports, and applications
- Interpretation of agency rulings, policies, and guidelines
- SOP review
- Reformulation strategies, particularly on large projects with short timelines
- Strategies to maximize labeling claims
- Data analysis
- Toxicology assessment
- Guidance on import/export procedures
- Recall advice and assistance
- Advisory board membership