FDA Regulatory Strategies

505b2 and FDA regulatory strategies - IRISYS

IRISYS creates tailored regulatory strategies 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. Our FDA regulatory consultants design and implement science-based strategic plans that have saved our clients time and money.

Regulatory strategies employed by our clients include the “505 (b)(2) FDA approach”, which allows pharma companies with specified types of drugs the opportunity to acquire FDA approval without performing all the work required for a full NDA. With the guidance of IRISYS’ FDA regulatory consultants, our clients have used 505 (b)(2) as a cost-efficient pathway for approval of their drug products.

The 505 (b)(2) FDA regulatory strategy (sometimes noted as “505b2”) allows a pharmaceutical company to include data and/or study results from other sources in an FDA filing. Our FDA regulatory consultants can help you determine if your product is eligible for this regulatory strategy. We can help you build supporting evidence between your 505 (b)(2) eligible product, or its active ingredients, and the reference product in order to meet the requirements for FDA approval.

Regulatory strategic planning

IRISYS’ FDA regulatory consultants will create a regulatory strategy that:

  • Is based on your specific product and proposed application
  • Includes 505(b)(2) FDA 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, contact us below: