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.

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 […]

FDA Firsts and Updates: Competitive Generics, Complex Generics, SiRNA approval, and Closing the Orphan Loophole

FDA Firsts and Updates: Competitive Generics, Complex Generics, SiRNA approval, and Closing the Orphan Loophole

We decided to mention some noteworthy firsts from the FDA during August 2018 and a change in the FDA’s policy on obtaining orphan incentives via pediatric-subpopulation designation. Competitive Generic Therapy Designation The FDA granted Competitive Generic Therapy (CGT) designation for the first time for Potassium Chloride oral solution (ANDA 211067; Apotex, Inc; approved 8 August […]

GDUFA I and II: Considerations for Complex Generics Innovators

GDUFA I and II: Considerations for Complex Generics Innovators

The increasing complexity of brand-name drugs has made development of generic alternatives more challenging as well. As complex generic drug products can provide a high-value opportunity for drug development companies, they are similar to 505(b)(2) products in that they may require early and flexible interaction with the FDA. The same expertise Camargo holds in developing […]

Orphan Exclusivity for ‘Same Drug’: What Has Changed Since FDARA 2017/ PDUFA VI?

Orphan Exclusivity for ‘Same Drug’: What Has Changed Since FDARA 2017/ PDUFA VI?

Last month the US District Court for the District of Columbia ordered the FDA to grant Eagle Pharmaceuticals, Inc., 7-years of marketing exclusivity for Bendeka® (bendamustine). This was the second loss for the FDA regarding orphan exclusivity for the ‘same drug’ that is not clinically superior to the approved product, but it is likely among […]

505(b)(2) Nonclinical Development: Examples and Advantages

505(b)(2) Nonclinical Development: Examples and Advantages

The 505(b)(2) New Drug Application (NDA) pathway can provide unique advantages from the nonclinical development perspective that can save significant amounts of time, money, and resources. Compared to the 505(b)(1) NDA pathway, which is more standardized and follows the general guidance provided by the International Conference on Harmonization (ICH) M3[1], the nonclinical development program under […]