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Market Intelligence and Strategy

ClinChoice 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.

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