Develop Viable Products

Put your Product On The Path To Approval And Your Business On The Path To Profitability

Camargo systematically builds and executes complete development plans that align with business strategies and that ensure FDA buy-in every step of the way. With the Camargo integrated team approach, we will manage every facet of the program throughout your development continuum, from formulation and testing of the drug product to conducting nonclinical and clinical studies (if necessary), to final submission.

Regulatory Strategy

Since our beginning, Camargo focused on providing unparalleled regulatory expertise. Today, that focus remains, and we’ve built an exceptional track record to show for it. We have an outstanding history of first-cycle FDA approvals, and now lead the largest percentage of 505(b)(2) submissions of any team submitting to the FDA. Camargo is truly the world’s leader for developing products via the 505(b)(2) regulatory pathway.

FDA meetings and submissions

  • IND preparation and submission
  • NDA preparation and submission
  • ANDA preparation and submission
  • 505(b)(2) NDA preparation and submission

Learn more about our FDA meetings and submissions

Additional regulatory services

  • Audit services
  • U.S. agent/representative for non-U.S. firms
  • Citizen petitions and Freedom of Information Act (FOIA) requests
  • Remediation strategy and execution

Learn more about our additional regulatory services

Nonclinical Testing

  • CRO selection
  • Study design
  • Study setup and execution
  • Project management

Learn more about Nonclinical Testing

Chemistry, Manufacturing And Controls (CMC)

  • API (CMO sourcing, specifications, test methods, etc.)
  • Formulation
  • Stability testing and shelf-life determinations
  • Analytical methods development and validation
  • Clinical trial materials and packaging
  • CMO oversight
  • Audit services

Learn more about Chemistry, Manufacturing, and Controls (CMC)

Clinical Studies, Phase I-IV

Phase I

  • Protocol review, design and implementation
  • Investigator/site identification and management
  • Complete CRO services and management
  • First-in-human studies
  • Pharmacokinetics/pharmacodynamics studies
  • Drug-drug interaction studies
  • Quality processes and support
  • Medical writing
  • Regulatory submissions and support

Phase II-III

  • Medical feasibility
  • Clinical development plans
  • KOL identification and management
  • Complete CRO services and management
  • Global Phase II studies
  • Proof-of-concept study design
  • Registration study designs and assessments
  • Vendor management and coordination
  • Medical writing
  • Clinical supplies management
  • Regulatory operations, submissions and support

Phase IV

  • Post-marketing services
  • Medical communications
  • Commercial support services

Learn more about Clinical Studies, Phases I-IV

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