About Us

About Camargo

Camargo-team
Camargo Pharmaceutical Services is the most experienced global strategist providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and analogous European processes. By assessing the scientific, medical, regulatory and commercial viability of product development opportunities, Camargo systematically builds and executes complete development plans that align with business strategies and that ensure FDA buy-in every step of the way. Routinely holding three to six pre-IND meetings a month, Camargo has guided more than 200 FDA approvals and works with product developers across more than 25 countries.

Camargo is passionate about helping companies like yours make new, enhanced, and differentiated therapeutic benefits a reality.

History

Ken-at-DRC-Chicago-bIn 2003, Camargo was founded in Cincinnati by Ken Phelps (president and CEO) and Dr. Ruth Stevens (chief scientific officer and executive vice president). It’s no coincidence that 2003 was also the year the FDA introduced guidelines governing the 505(b)(2) approval pathway. From the beginning, Camargo has focused solely on being the industry’s 505(b)(2) development partner of choice. Just five years after opening, Camargo was recognized as one of Cincinnati’s 55 fastest-growing private companies. In 2011, Camargo opened a second location in Durham, N.C., in the Research Triangle Park. Today, Camargo partners with companies in more than 25 countries worldwide and has led the largest percentage of 505(b)(2) submissions of any team submitting to the FDA — Camargo is the industry authority in 505(b)(2).

Expertise In Every Shape And Form

FDA Experience

No matter what type of product you’re looking to develop, with Camargo, you can be sure the people behind your research projects are leaders in their respective therapeutic areas with proven experience working with the U.S. Food and Drug Administration (FDA). Our experts average two decades of experience and have working relationships with FDA officials across all major therapeutic areas.

  • Office of Antimicrobial Products
  • Division of Cardiovascular and Renal Products
  • Division of Neurology Products
  • Division of Psychiatry Products
  • Division of Anesthesia, Analgesia and Addiction Products
  • Division of Metabolism and Endocrinology Products
  • Division of Pulmonary, Allergy and Rheumatology Products
  • Division of Dermatology and Dental Products
  • Division of Gastroenterology and Inborn Errors Products
  • Division of Bone, Reproductive and Urologic Products
  • Office of Hematology and Oncology Drug Products

Marketed Product Types

The 505(b)(2) approval pathway can be used for any approved or unapproved compound for which there is sufficient public data and is particularly useful for those compounds that represent a limited change from an approved drug.

Ideal candidates include:

  • Drugs with new indications for an approved drug
  • Drugs with changes in dosage form, strength, formulation, dosing regimen or route of administration
  • New combination products (i.e., drug/device, biologic/device, drug/biologic or drug/device/biologic)
  • Drugs with new active ingredients (i.e., ones not previously approved in the US, but where significant information exists about the active ingredient’s safety and efficacy)
  • Prodrugs of an existing drug (Read More)
  • Branded generics (Read More)
  • Over-the-counter (OTC) monograph drugs
  • Orphan drugs (Read More)
  • Drug efficacy study implementation (DESI) drugs* (Read More)

Drug Delivery

New technologies have made more drug delivery techniques and options available than ever before. Moreover, pharmaceutical developers, biotechnology companies and CMOs are partnering in unique ways to produce viable solutions. From candidate identification and CMC, to shaping regulatory and commercial approaches, Camargo is an expert in seeking out and assessing your options and will help you set a sound strategic foundation for feasible development no matter the delivery mechanism. Across all sterile and non-sterile routes of administration, count on Camargo’s expertise to guide successful development.

  • Buccal
  • Injectable: Intravenous, intrathecal, subcutaneous
  • Nasal and inhalation
  • Ophthalmic
  • Oral: Immediate release, sustained release, suspension
  • Transdermal (topical): Cream, gel, patch
  • Vaginal and rectal: Cream, gel, suppository

*Camargo’s customized approach to navigating the 505(b)(2) development pathway presents the opportunity to secure approval for DESI drugs. The FDA’s DESI program was enacted to evaluate the efficacy of all drug products approved and marketed on safety grounds alone between 1938 and 1962. Although these DESI-approved drugs may continue to be marketed until the administrative proceedings evaluating their effectiveness have concluded, continued marketing is permitted only if an NDA is approved for such drugs. Currently, the FDA is pursuing an Unapproved Drugs Initiative against as many as 3,000 drugs still on the market without approval. For many of these drugs still in limbo, a direct path to an NDA and possible marketing exclusivity may be obtainable.

Need 505(b)(2) Help?

We’re impressed by the quality and thoroughness of the submission package … we want to engage you on another product, not just the Pre-IND but all the way through NDA.

VP, R&D Biotech