Regulatory Consulting and Review

With over 150 FDA approvals and an outstanding history of first-cycle FDA approvals, our regulatory track record speaks for itself. If a clinical study or IND program has been put on clinical hold, Camargo has the expertise to interact with the FDA to get the drug development program back on track.

Camargo's expertise in regulatory affairs and submissions runs the drug development gamut: pre-IND and IND preparation and submissions; pre and post-IND and NDA meetings with the FDA; and the preparation and submission of NDAs, ANDAs and 505(b)(2) NDAs.

We provide regulatory advice and problem-solving, as well as advocacy on your behalf, in addition to:

• Strategic planning
• Regulatory support for clinical trials
• CMC and pre-clinical toxicology
• Regulatory agency interaction
• Writing and compilation of INDs, NDAs, ANDAs, 505(b)(2)s and supplements
• eCTD submission

IND Preparation & Submission
The overall quality of an IND application is largely dependent on an understanding of the requirements and its degree of FDA guidance-compliance. With a former FDA lead reviewer as a member of Camargo, we understand how to evaluate product data and plan the regulatory strategy, as well as ensure clarity, accuracy and consistency within documents to be included in the IND and NDA. We have a strong history of effective communication with the FDA, and frequently function as a liaison to arrange the pre-IND meeting, end of Phase II meeting, or pre-NDA meeting and prepare meeting briefing documents. We also assist with the preparation and submission of IND amendments for protocol changes or the addition of investigators.

NDA Preparation & Submission
Camargo's integrated regulatory competencies are designed to enhance the quality, organization and completeness of FDA NDA applications. We are guided by four key principles at every stage:

• Inclusion of adequate data
• FDA guidance compliance
• Understanding and fulfillment of reviewers' requirements
• Efficient FDA review utilizing eCTD submissions

ANDA Preparation & Submissions
Camargo's strategic approach to successful ANDA submissions focuses on gathering the appropriate ANDA information to insure a complete application and conducting the right clinical studies. We rely on our years of experience and expertise to power bioequivalence (BE) studies appropriately and minimize study failures. This competency in clinical study design is invaluable for ANDAs that require clinical endpoint studies.

505(b)(2) NDA Preparation & Submissions
Based on Camargo's success with 505(b)(2) submissions, our distinctive process for these applications is one of the most efficient and effective in the industry. The average time-to-market for our clients who use this approval route is two to two-and-one-half years from the initiation of the clinical program. Camargo's proven success with this type of application results from our detailed knowledge of FDA filing requirements, use of established and well-accepted methodologies, and design of well-focused clinical studies.

Audit Services
Camargo's comprehensive audits of bioequivalence studies and bioanalytical analyses assure the accuracy of data submissions to the FDA and help expedite drug approval and market launch. When sponsors of pending or approved abbreviated new drug applications(s) (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."

Team Camargo's panel of scientific and regulatory experts provides impeccable audits that meet the highest professional and FDA scrutiny.

During Phase IV, Camargo partners closely with you to help increase new drug marketability. Drawing on our relationships with seasoned marketing experts in the pharmaceutical industry, we have built a solid, highly customized strategy that incorporates regulatory and marketing objectives, along with a well-defined integrated action plan to maximize the drug product's potential. From strategic branding through carefully planned implementation, Camargo can help drive physician preference, consumer requests and sales.

Some of Camargo's Phase IV activities and marketing tactics may include, but are not limited to:

• Abstract development
• Clinical presentations
• Document retrievals and literature searches
• Article writing for scientific publication
• Medical advisory boards