Technical / white paper
19-Mar-2013 -
When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different animal. This pathway offers a holistic approach for developing products that offer differentiated benefits with Lower Risk, Reduced...
Data sheet
13-May-2013 -
505(b)(2) is more than just a regulatory pathway, it is a distinctly different animal — a unique strategy that can often result in product approval with lower risk, reduced development cost and faster speed to market. Find out if 505(b)(2)...
Product brochure
29-Sep-2008 -
Product brochure
24-Feb-2009 -
Camargo Pharmaceutical Services is a full-service CRO for the continuum of drug development. Focused in: CMC, formulation development, clinical services, pharmacokinetic analysis and regulatory consulting—specializing in 505(b)(2). Click here for brochure.
Event programme
23-Sep-2009 -
Historically, the 505(b)(2) pathway is used for modifications of approved drugs. Yet, regulations state that a new chemical entity can also be approved under this FDA approval pathway. Camargo experts will discuss this process at the CHI: Drug Repositioning Summit,...
Data sheet
08-Jun-2009 -
Discover how Camargo Pharmaceutical Services’ expertise in the 505(b)(2) approval pathway can teach old dogs new tricks. In this Q&A, Ken Phelps discusses 505(b)(2) - how it differs from 505(b)(1), its myriad of benefits, its continuing evolution, and its current...
Product brochure
01-Sep-2009 -
By the time he founded Camargo Pharmaceutical Services in 2003, Ken Phelps had already amassed more than 30 years of experience in the health science and services industry. With a broad background in drug development, specifically the 505(b)(2) regulatory approval...
Data sheet
09-May-2011 -
Camargo Pharmaceutical Services executes 505(b)(2) drug development programs for small and large molecules. With 3-5 pre-IND meetings a month and worldwide reach in 26 countries; it’s easy to see how our success breeds your success. Download more on 505(b)(2)
Technical / white paper
15-Jun-2011 -
Camargo Pharmaceutical Services specializes in the 505(b)(2) pathway globally, executing drug development programs for small and large molecules. A rising tide of submissions attests to the increased importance of the 505(b)(2) approval pathway. Download the technical paper for:
An outline of...
Data sheet
17-Oct-2011 -
The 505(b)(2) pathway can lead to approval for new drugs in a fraction of the time and cost required by traditional paths; but special requirements demand a thorough understanding of the FDA and its evolving standards. See us at AAPS...
Data sheet
28-May-2012 -
As a fast and cost-effective route for drug approval, more products than ever are approved via the 505(b)(2) pathway. Camargo Pharmaceutical Services is your go-to expert for 505(b)(2) approvals that provide product differentiation and a period of market exclusivity.
Data sheet
20-Jun-2012 -
Looking to embark on a 505(b)(2) product approval?More products than ever are approved via the 505(b)(2) pathway — a fast and cost-effective route for drug approval. With global reach across 26 countries, Camargo Pharmaceutical Services executes 505(b)(2) drug development programs...