FDA Regulatory Strategies

505b2 and FDA regulatory strategies - IRISYS

IRISYS creates tailored plans for achieving product approvals as quickly and cost-effectively as possible. Decades of experience working with regulators gives us the insight to pursue non-traditional approaches. We design and implement science-based strategic plans that have saved our clients time and money.

Regulatory strategic planning

IRISYS will create a regulatory plan that:

  • Is based on your specific product and proposed application
  • Includes 505(b)(2) strategy assessment
  • Includes a risk assessment
  • Considers your timeline and financial resources

Evaluation of product development, processes and procedures for regulatory compliance

IRISYS will:

  • Analyze the scientific basis and history of your product
  • Determine what further testing is needed to fulfill regulatory requirements
  • Conduct preformulation development studies
  • Conduct dosage form development Activities
  • Prepare specialized formulations as needed
  • Provide world-class analytical chemistry and preclinical development services

For more information about our FDA Regulatory Strategies services, fill out the contact form below: