FMD K&L regulatory consultants provide a wealth of knowledge on the most current regulations, directives, laws, policies, and guidelines issued by authorities around the world
We sift through the often-arcane language of regulation to understand details, interpret guidelines, and recommend the right course of action for your company. We provide regulatory advice, develop strategies for challenging situations, and advocate on your behalf to regulatory agencies.
Regulatory strategy consulting
- Regulatory strategic planning from design to market for drugs, devices & consumer health products
- Specialized strategic planning for fast-tracked & orphan products
- Advice on biologics, biosimilars, biotech products & advanced therapies
- Product classification review
- FDA representation at key milestone meetings
- Labeling & advertising review
- Development of risk management plans (RMPs) and risk evaluation and mitigation strategies (REMs)
- Strategies for reformulation of cosmetic & consumer health products, particularly on large-scale programs with short timelines
Regulatory intelligence consulting
- Leverage current regulatory approvals to penetrate new markets quickly & cost effectively
- Access, summarize & assess global regulatory intelligence to ensure submission compliance with regional & local requirements
- Ongoing surveillance of regional & local authorities to ensure that product development & registration planning strategies are sound & rigorous
- Survey competitive landscape & utilize competitive gap analysis techniques to provide regulatory intelligence supporting product benchmarking
Regulatory compliance consulting
With expertise in product development, current technologies, and global regulation, our consultants assess client compliance from all perspectives: processes, tools, and people.
- Assessment of current compliance level
- Harmonization & development of standard operating procedures (SOP)
- Audits of independent quality systems (ISO, GCP, GLP, GMP, GCDMP, GPVP), facilities, vendors, processes, projects, programs & studies
- Management of corrective & preventive action (CAPA) programs
- Development of tools for monitoring & tracking compliance
All services are available on an annual contract or project basis.