Regulatory Strategy Services

More Experience. More Success. More Accomplished Than Any Other Partner.

After working with clients worldwide for more than a decade, we’ve established something completely unrivaled in terms of 505(b)(2) investigational new drug (IND) and new drug application (NDA) preparation and submission: our regulatory track record. Camargo is the world’s leader for developing products via the 505(b)(2) approval pathway.

Camargo’s team:

  • Leads the largest percentage of 505(b)(2) submissions of any team submitting to the FDA
  • Has guided 200+ FDA NDA approvals
  • Holds 3 to 6 pre-IND meetings a month
  • Upholds a 95%+ FDA concurrence rate for fulfilling NDA approval requirements
  • Works with partners across 25+ countries
  • Includes former FDA team leaders and some of the top regulatory staff in the world
  • Offers extensive therapeutic expertise: Camargo has filed with every division of the FDA’s Office of New Drugs numerous times
  • Has brought all types of products to market (e.g., drugs with new indications, branded generics, orphan drugs)
  • Is experienced across all drug formulation and delivery types (e.g., routes of administration, dosage forms, sterile/non-sterile)

The Camargo Process

Camargo’s outstanding history of first-cycle FDA approvals is testament to our ability to work as your FDA liaison and ensure regulatory alignment every step of the way from concept to commercialization. We provide regulatory advice and problem-solving as well as advocacy on your behalf. Even in cases where your clinical study or IND program has been put on clinical hold, Camargo will step in and work with the FDA to put your drug development program back on track. Camargo has a proven process for FDA planning, execution and submissions in order to achieve both development and corporate milestones; this is reflected through our long history of success with the agency and numerous clients that return to us.

  • Pre-IND and IND preparation and submission
  • Pre- and post-IND and NDA meetings with the FDA
  • Preparation and submission of NDAs, ANDAs and 505(b)(2) NDAs

Regulatory Services

  • Strategic planning
  • Support for clinical trials
  • Chemistry, manufacturing and controls (CMC) and nonclinical toxicology studies
  • Regulatory agency interactions
  • Writing and compilation of INDs, NDAs, ANDAs, 505(b)(2)s and supplements
  • Electronic common technical document (eCTD) submission

Development and Approval Strategy Formulation

Traditional drug development via the 505(b)(1) approval pathway takes an average of 12 years from end to end. In contrast, a 505(b)(2) development program can be completed in just two to five years. But this shortened development pathway demands expertise — Camargo is adept at navigating the regulatory waters surrounding 505(b)(2). Our team specializes in de-risking and shortening development programs. In particular, we design development plans to acquire and present data, study reports and well-reasoned arguments to meet the strategic needs of your company, address regulatory requirements and fulfill the needs of your target markets, often niche markets. Through exacting feasibility assessment, gap analysis and typical work requests (e.g., IND, pre-INDs), every step we take is toward viable product approval, no matter the product form or therapeutic indication at hand.

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