Every interaction with the FDA is a crucial moment for your development program, and meetings represent a culmination of compiled and scheduled work. Strategies, timelines, costs and complexity are all organized through this interaction — the stakes are high, and the outcomes are extremely important. It all comes down to strategic communication. Every facet of FDA meetings — from the information your company is providing, to scientific research and the tone and articulation of that information — must be conducted flawlessly. Camargo will compose your communications for submissions and perform all preparation for these meetings. From experience, we know the nuances at play when expressing understanding of laws and issues, and how to analyze and interpret data accurately to present it clearly and concisely through written documents and in-person meetings.
- Pre-IND and other FDA meetings
- Pre-NDA meetings and other peri-approval meetings
In the ever-competitive marketplace(s) you compete in, exclusivity is often the only way to secure a singular advantage. 505(b)(2) offers an opportunity for developers to secure up to three, five or — for orphan products — seven years of exclusivity. Moreover, there are intricacies that allow for extended exclusivity (e.g., if the FDA requests pediatric studies on a new drug, the drug may be eligible for six additional months of exclusivity). Camargo is experienced in attaining and winning every type of 505(b)(2) exclusivity and tailors development programs for the life of products to maximize commercial opportunity.
IND Preparation and Submission
The overall quality of an IND application is largely dependent on the degree to which the requirements of the FDA’s regulations and guidance documents are met; the quality of data and the clarity of the presentation; and the cogency of the positions (interpretations and conclusions) made in the submission.
With seasoned regulatory professionals and former FDA reviewers on our team at Camargo, we understand how to evaluate product data and plan the regulatory strategy as well as how to ensure clarity, accuracy and consistency across documents to be included in INDs and NDAs. We have a proven history of effective communication with the FDA and frequently function as a liaison to arrange and facilitate pre-IND meetings, end of Phase II meetings and pre-NDA meetings, while also preparing the briefing documents. We also assist with the preparation and submission of IND amendments for protocol changes or the addition of investigators.
NDA Preparation and Submission
- Inclusion of adequate data, together with effective synthesis and interpretation of data, to support product approval
- Compliance with applicable FDA regulations and guidances
- FDA reviewer requirements are met
- eCTD submissions fully conform with FDA specifications
ANDA Preparation and Submission
Camargo’s strategic approach to successful ANDA submissions focuses on gathering the appropriate ANDA information to ensure a complete application while conducting the right clinical studies. We rely on decades of experience to power bioequivalence studies and minimize study failures. This competency in clinical study design is invaluable for ANDAs that require clinical endpoint studies.
505(b)(2) NDA Preparation and Submission
Based on our 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-a-half years from the initiation of the clinical program. Camargo’s demonstrated success with this type of application derives from our detailed knowledge of FDA filing requirements, use of established and well-accepted methodologies and design of properly focused clinical studies.