Articles

11. Brochure: Custom Synthesis 12/6/2010

    PharmaZell draws upon a long history of successful custom synthesis projects, performed on a proprietary basis for pharmaceutical companies worldwide.

12. Brochure: Contract Manufacturing 8/6/2010

    Drug Substance and Advanced Intermediate development and manufacture to support clinical through commercial requirements.

13. Poster: CMC For 505(b)(2) Applications 4/7/2010
    The Chemistry, Manufacturing, and Control (CMC) Section (Modules 2 & 3 of the Common Technical Document [CTD]) of any application to the FDA will be the cornerstone for demonstrating the quality of any drug product. A clear document that complies with the ICH Harmonized Tripartite Guideline per the ICH Steering Committee Meeting (9 Nov 2000) is instrumental to that process. By Lynn Gold, PhD, Ken Phelps, Kathryn Wekselman, PhD, RN, and Karen Seta-Aust, PhD, Camargo Pharmaceutical Services, LLC
14. CMC For 505(b)(2) Applications 4/7/2010
    The Chemistry, Manufacturing, and Control (CMC) Section (Modules 2 & 3 of the Common Technical Document [CTD]) of any application to the FDA will be the cornerstone for demonstrating the quality of any drug product. A clear document that complies with the ICH Harmonized Tripartite Guideline per the ICH Steering Committee Meeting (9 Nov 2000) is instrumental to that process. By Lynn Gold, PhD, Ken Phelps, Kathryn Wekselman, PhD, RN, and Karen Seta-Aust, PhD, Camargo Pharmaceutical Services, LLC
15. Q&A: Understanding The 505(b)(2) Approval Pathway 5/28/2009

    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 pathway, Phelps has aided in the successful FDA approval of numerous compounds. Today, his company provides a full spectrum of drug development capabilities, from pre-clinical feasibility assessments to clinical program development to regulatory review and submission.

    In this Q&A, Phelps discusses 505(b)(2) — how it differs from 505(b)(1), its myriad of benefits, its continuing evolution, and its current and future impact on drug development.

16. Brochure: 505(b)(2) — Who Says You Can't Teach An Old Dog New Tricks 11/13/2007
    Brochure: 505(b)(2) — Who Says You Can't Teach An Old Dog New Tricks
17. Case Study: Pharmacokinetics - Client Wins With Unique Camargo Methodology 6/27/2006
    Demonstrate equivalency of clinical and commercial batches of the same drug