Regulatory Advisory Services and Compliance Implementation

We help our clients reach goals more quickly and confidently.

FDA pathways addressed:

  • 505(b)(1) for new drug entities

  • 505(b)(2) products, especially combination products that include a mix of drugs, devices, software, and/or tests

  • 505(j) for ANDAs

  • 510(k) for medical devices, especially connected medical devices and their associated cybersecurity and data regulations

Our understanding of FDA regulations and their connection to reimbursement strategies can shorten your journey to valuable milestones. And we assist with ongoing compliance requirements for commercial success throughout the product life cycle.

Key steps on the 505(b)(2) pathway

Step 1: Assessment

Review of your product to determine fit for the 505(b)(2) pathway. We assess existing data, identify data gaps, and strategize for a successful submission.

Step 2: Feasibility

Design and conduct studies to fill data gaps, ensuring that your product meets regulatory standards. This may include comparative effectiveness studies, safety assessments, and other necessary evaluations.

Step 3: Strategy

We collaborate with you to develop a comprehensive plan that addresses regulatory challenges and maximizes reimbursement prospects. Leverage our knowledge of eCTD strategy and industry best practices.

Step 4: Alignment with Regulatory Agencies

Effective communication with regulatory agencies ensures a clear path forward and can expedite the regulatory review process.

Step 5: Risk Mitigation

Implementation of risk mitigation strategies are critical for drug-device combinations.

Step 6: Submission and Follow-Up

Compose the submission and handle inquiries or requests for additional information.

Key steps to 510(k) clearance

Step 1: Determination of Substantial Equivalence

Determine substantial equivalence to a legally marketed device.

Step 2: Testing and Data Collection

Design and execute the necessary testing and data collection to demonstrate the safety and effectiveness of your medical device.

Step 3: Preparation of 510(k) Submission

Compile a comprehensive 510(k) submission package, including device descriptions, labeling, and performance testing data. Our goal is to provide a submission that meets regulatory requirements and facilitates a timely review.

Step 4: Submission and Post-Submission Support

Submit the 510(k) application and support the review process by adequately addressing queries from regulatory agencies.