CAMARGO IS THE LEADER IN 505(b)(2) DRUG DEVELOPMENT

As the global 505(b)(2) experts, Camargo specializes in developing and delivering a faster,  lower cost, and lower risk program.

Identify Viable Products

Camargo has a disciplined approach to evaluating the scientific, medical, regulatory and commercial aspects of your product development opportunities to make correct go/no-go decisions throughout your project.

Develop Viable Products

With our integrated approach, the team at Camargo manages every facet of your program, from formulation and testing of the drug product to conducting nonclinical and clinical studies, to final FDA submission.

Regulatory Strategy

After more than a decade, Camargo Pharmaceutical Services has established something unrivaled in terms of 505(b)(2) investigational new drug (IND) and new drug application (NDA) preparation and submission.

Why Go With Camargo?

If you’re looking to reposition an existing product or expand your portfolio with a differentiated product, the 505(b)(2) approval pathway is your best way forward, and Camargo is your ideal partner. As the leader in 505(b)(2), we’re your go-to for identifying commercially viable products and executing faster, more cost-effective development from concept to commercialization.

We have the largest percentage of 505(b)(2) submissions.

We have guided more than 200 FDA NDA and ANDA approvals.

We routinely hold three to six pre-IND meetings a month.

We work across more than 25 countries worldwide.

What Our Clients Are Saying

Learn more about what it’s like to work with the team at Camargo.

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

The text from the gap analysis has a fair and balanced perspective and provides substantial insights we have not yet considered for our drug development strategy.

R&D Director, Biotech

We have been extremely impressed with the level of high-quality input, guidance and work products we have received from all of the consultant team at Camargo. Camargo has not only demonstrated a superb first-hand knowledge of the most current FDA guidance documents and regulations, but also a willingness to explore and weigh-out regulatory strategies and options as shaped from their own experience with FDA. I would highly recommend Camargo to anybody in the 505(b)(2) space and look forward to working with Camargo on a wide-range of regulatory projects.

Biotech CSO

Assisting us in our discussions with the FDA is Camargo, as our FDA liaison and regulatory strategic partner. Cingulate is increasing the prospect for success via the accelerated 505(b)(2) pathway and Camargo has an outstanding track record of directing products through the FDA approval process. Camargo has guided 200+ FDA drug approvals and are at work with us to ensure regulatory alignment every step of the way from concept to commercialization which we will believe will increase the likelihood of FDA approval and future market success.

Biotech CEO, Improved Formulation

It is important to think end-to-end, especially in a 505(b)(2) program. If you don’t plan it all out, you can build a bridge to nowhere. If you haven’t thought the regulatory plan and reimbursement plan out, you won’t be able to convince investors to invest in your program. That is what differentiates Camargo from other regulatory consultants in the industry. They really take an approach that is an extension of your team. They take the end-to-end approach which is let’s map out where you want to go and what your overall vision is as a company…. I can’t speak highly enough of Camargo’s approach. This team-based aspect of being a partner all the way to the end is something that is really important to a 505(b)(2) program, especially if you intend to leverage that platform to other products.

Biotech CEO, Drug Delivery Technology

Conferences and Events

Here are a few of the conferences and events the Camargo team will be attending and participating in this year. Hope to see you there.

The Latest from the Blog

Read the latest insights and information from our 505(b)(2) blog.

Nonclinical Study Requirements for 505(b)(2) Development

Nonclinical Study Requirements for 505(b)(2) Development

On June 1, 2018, Camargo Pharmaceutical Services celebrated our 15th Anniversary. For this week’s blog, Camargo co-founders, Dr. Ruth Stevens, Chief Scientific Officer and Executive Vice President, and Ken Phelps, President, discuss an important question Camargo often hears from prospective clients: What Nonclinical Study Requirements Do I Have for my 505(b)(2) Drug Development Project?   […]

What Clinical Studies Are Needed for a 505(b)(2) Development Project?

What Clinical Studies Are Needed for a 505(b)(2) Drug Development Project?

On June 1, 2018, Camargo Pharmaceutical Services celebrated our 15th Anniversary. For this week’s blog, Camargo co-founders, Dr. Ruth Stevens, Chief Scientific Officer and Executive Vice President, and Ken Phelps, President, discuss an important question Camargo often hears from prospective clients: What Clinical Studies Do I Need to Run for my 505(b)(2) Drug Development Project? […]

Ken Phelps speaking at IGBA with Value Added Medicines

Europe’s Value Added Medicines Initiative

The European Union (E.U.) and the United States (U.S.) both have regulations that allow existing drugs to be improved. The E.U. pathway is limited to improvements of drugs that were approved in the E.U. and that are now generic. Readers of this blog are familiar with the U.S. 505(b)(2) pathway that is not restricted to […]

Number of Complete Response Letters by Approval Type

Complete Response Letters (CRLs): Big Trouble for Small Pharma

A Complete Response Letter (CRL) can have a devastating effect on a small company’s share value, as evidenced by the recent examples of Recro Pharma and Cosmo Pharmaceuticals. A recent EP Vantage analysis of publicly-reported Complete Response Letters (CRLs) issued by the FDA from 1 January 2017 until 30 May 2018 had surprising results. The […]

505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success

505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success, Q&A Part 2

Last week, we posted the first part of Q&A from recent webinar 505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success Camargo President and Co-founder, Ken Phelps, held with Fierce Biotech. Because of the great questions asked by the many active participants, we are sharing Part 2 of the Q&A here with our brief […]

505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success

505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success, Q&A Part 1

Earlier this month, Camargo President and Co-founder, Ken Phelps, held a webinar 505(b)(2) Strategy for Biotech Execs: Positioning Your Products for Success with Fierce Biotech. Because of the great questions asked by the many active participants, we are sharing the Q&A here with our brief answers, along with a link to access the recorded webinar, […]