We provide consultation on:
- Strategy
- Intelligence
- Compliance
Regulatory strategy consulting
- Regulatory strategic planning from design to market for drugs, devices, and consumer health products
- Specialized strategic planning for fast-tracked and orphan products
- Advice on biologics, biosimilars, biotech products, and advanced therapies
- Product classification review
- FDA representation at key milestone meetings
- Labeling and advertising review
- Development of risk management plans (RMPs) and risk evaluation and mitigation strategies (REMs)
- Strategies for the reformulation of cosmetic and consumer health products, particularly on large-scale programs with short timelines
Regulatory Intelligence Consulting
- Leverage current regulatory approvals to penetrate new markets quickly and cost-effectively
- Access, summarize, and assess global regulatory intelligence to ensure submission compliance with regional and local requirements
- Ongoing surveillance of regional and local authorities to ensure that product development and registration planning strategies are sound and rigorous
- Survey competitive landscape and utilize competitive gap analysis techniques to provide regulatory intelligence supporting product benchmarking
- Comparative analysis of similar products available on the market
- Impact assessment of health authority updates
- Assessment and strategy for multiple product registrations
Regulatory Compliance Consulting
- With expertise in product development, current technologies, and global regulations, our consultants assess client compliance from all perspectives: processes, tools, and people.
- Our compliance services include:
- Assessment of current compliance level
- Harmonization and development of standard operating procedures (SOP)
- Audits of independent quality systems (ISO, GCP, GLP, GMP, GCDMP, GPVP), facilities, vendors, processes, projects, programs, and studies
- Management of corrective and preventive action (CAPA) programs
- Development of tools for monitoring and tracking compliance