phamax scientific analytics : Regulatory assessment

Planning for compliance with regulatory changes

Our services help companies manage risks and unlock value by engaging effectively with regulators, policymakers, and other external stakeholders. phamax assesses commercial, clinical and market-specific regulatory factors for crucial insights on market dynamics and evolution vital to address payer expectations and secure favorable reimbursement status.

The phamax regulatory assessment uses three customizable dimensions:

  • Research to answer key intelligence questions (KIQs)

  • Collaboration with local regulatory stakeholders to address information gaps

  • The phamax scientific network to refine the insights

We simplify reporting processes, making regulatory filings less demanding. We provide country-specific regulatory landscape reports using the phamax scientific network with inputs from the local regulatory systems and stakeholders. Our solutions help companies comply with the local, regional and global regulatory requirements impacting products.

The phamax regulatory services:

  • Identify the regulatory requirements, and the market and customer drivers
  • Develop regulatory strategies and submissions
  • Help to implement compliance assurance processes
  • Provide direct access to on-call consulting support
  • Provide regulatory and research Q&A style support
  • Provide real-time information change notices (ICNs) on important changes
  • Substantiate waiver requests and read-across arguments
  • Provide product safety and efficacy evaluations
  • Provide third-party technical liaisons

– Understand the regulatory landscape to answer the KIQs on:

  • Pricing systems
  • Pricing and reimbursement processes
  • Roles and responsibilities of regulatory authorities
  • Recent case studies
  • Health economic evidence
  • Accessibility and affordability

– The realistic view of the market and product potential as per the core regulatory assessment principles
– Understand the impact of the changing market environment on the ever-changing regulatory guidelines
– Choose the right scenario from multiple options

Seek guidance to comply to regulatory policies.

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