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.

FDA Written Responses Only

Scope of Orphan Drug Exclusivity – How Broad is Broad?

It has recently been reported that drugmakers have argued against broad orphan exclusivity for Eagle Pharmaceuticals, Inc.’s Bendeka® product. This was in response to the FDA’s invitation to applicants of certain products containing bendamustine to share how broad of a scope they believe Eagle’s seven-year orphan drug exclusivity for Bendeka should be, and if it […]

Real world evidence and drug development

Market Assessment: Is Your Product Going To Make It On The Market?

A lot of our focus in previous blogs has been on how to best negotiate regulatory hurdles to get your product approved as quickly and cheaply as possible, and how to differentiate your product from the marketed products. And as we have previously blogged, to get a successful return on investment (ROI) for your product, […]

“Breakthrough” the Barriers: Breakthrough Therapy Designation for 505(b)(2

“Breakthrough” the Barriers: Breakthrough Therapy Designation for 505(b)(2)

“Breakthrough” the Barriers: Breakthrough Therapy Designation Will Speed Up the Development and Review Time for Your 505(b)(2) Product Breakthrough Therapy Designation (BTD) is the most recent addition to the suite of expedited programs offered by the FDA. In comparison to Fast Track Designation (discussed in a prior blog), the qualifying criteria for BTD are more […]

On the “Fast Track”: Fast Track Designations for Your 505(b)(2) Drug Development Program

On the “Fast Track”: Fast Track Designations for Your 505(b)(2) Drug Development Program

One of the tenets of the FDA is to get safe and effective drugs to market as soon as possible. To expedite products where there is the greatest clinical need, the FDA offers 4 expedited programs to get beneficial therapies to patients faster: Priority Review, Accelerated Approval, Breakthrough Therapy Designation, and Fast Track Designation. In […]

Are Botanical Drugs, Herbal Medicinal Supplements, and Natural Product Drugs 505(b)(2)s, Too?

Are Botanical Drugs, Herbal Medicinal Supplements, and Natural Product Drugs 505(b)(2)s, Too?

For centuries, botanical remedies have been used in many cultures to treat various diseases. In recent years, pharmaceutical companies have turned to botanical drugs for alternative medicines to treat diseases with unmet medical needs. The FDA also recognizes the interest in developing botanical products and released a draft guidance in 2004, finalized in 2016 as […]

Looking for Clarification on Reporting Post-Approval Changes to a Drug Substance to the FDA? You are in Luck.

Looking for Clarification on Reporting Post-Approval Changes to a Drug Substance to the FDA? You are in Luck.

This week the FDA released a new draft Guidance for Industry entitled “Post-approval Changes to Drug Substances” as part of the FDA’s commitment to the reauthorization of the Generic Drug User Fee Amendments (GDUFA II). The new draft Guidance fills an important void as the existing Guidance for Industry: Q11 Development and Manufacture of Drug […]