Additional Regulatory Services

Audit Services

Camargo has audit expertise in every domain (e.g., nonclinical, clinical, CMC, other regulated activities). Whether you need to proactively review and refine operational processes or need to implement an audit program in response to prior regulatory contention, Camargo is your partner.

Camargo’s comprehensive audits of bioequivalence studies and bioanalytical analyses reinforce the accuracy of data submissions to the FDA and help expedite drug approval and market launch. When sponsors of pending or approved ANDAs encounter FDA challenges to their studies, they turn to Camargo for professional validation of findings. Camargo meets or exceeds all FDA criteria for “audits conducted by a qualified independent expert.” Camargo’s panel of scientific and regulatory experts provides impeccable audits that meet and exceed the highest professional and FDA scrutiny.

U.S. Agent/Representative For Non-U.S. Firms

Camargo frequently acts as a domestic agent for international companies. Our presence and global understanding will guide the drug approval process, including all aspects of regulatory affairs, and facilitate imports to help bring your product to the U.S. market.

Citizen Petitions and Freedom of Information Act Requests

If you need to request that the FDA or other regulatory body take action, Camargo can develop your petition, for example, to incite the withdrawal of illegally marketed products. Camargo knows the citizen petition request process and can craft a request that will effectively help the agency draw proper conclusions. In the drug development industry, the Freedom of Information Act (FOIA) has opened the door for information on the deliberation and/or review of products. Camargo can help you prepare and submit an FOIA request to obtain valuable information. In the case of both citizen petitions and FOIA requests, Camargo can act as your public representative to keep your interests private.

Remediation Strategy and Execution

Adversarial relationships with regulators lead nowhere. Camargo has helped numerous companies settle disputes with agencies by clarifying the design and/or interpretation of results as well as misconceptions implicit parties may possess. Should the FDA return an adverse opinion and/or non-approval, Camargo expertly evaluates the technical and scientific details of FDA findings. We engage in a scrupulous process to identify issues and remediation strategies. Our team is proficient, for example, at transitioning programs off clinical hold to get NDAs submitted and filed, and then addressing challenges thereafter.

  • Clinical holds
  • 505(b)(2) NDA non-approval/refuse-to-file
  • Scientific dispute resolution