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Nonclinical Drug Development Consulting Services, LLC

Nonclinical Drug Development Consulting Services, LLC. Review of C,M&C sections of INDs, NDAs & ANDAs. Expert opinions of scale-up and validation protocols, data, and launch plans. SUPAC consultation and submission strategy. Pre-Approval readiness evaluation and preparation. Expert review of development pharmaceutics reports. Critique of analytical methods and validation packages. Critique of bioanalytical methods and validations. Optimization of dosage form design approaches.

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Nonclinical Drug Development Consulting Services, LLC. Review of C,M&C sections of INDs, NDAs & ANDAs. Expert opinions of scale-up and validation protocols, data, and launch plans. SUPAC consultation and submission strategy. Pre-Approval readiness evaluation and preparation. Expert review of development pharmaceutics reports. Critique of analytical methods and validation packages. Critique of bioanalytical methods and validations. Optimization of dosage form design approaches.
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Nonclinical Drug Development Consulting Services, LLC | drugdevconsult.com Reviews

https://drugdevconsult.com

Nonclinical Drug Development Consulting Services, LLC. Review of C,M&C sections of INDs, NDAs & ANDAs. Expert opinions of scale-up and validation protocols, data, and launch plans. SUPAC consultation and submission strategy. Pre-Approval readiness evaluation and preparation. Expert review of development pharmaceutics reports. Critique of analytical methods and validation packages. Critique of bioanalytical methods and validations. Optimization of dosage form design approaches.

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Nonclinical Drug Development Consulting Services, LLC

http://www.drugdevconsult.com/publications.html

Selected Publications and Presentations. Van Buskirk, G.A. et. al., Passive Transdermal Systems Whitepaper Incorporating Current Chemistry Manufacturing and Controls (CMC) Development Principles,. Jan 4, 2012. Van Buskirk, G. A., Layloff, T. P., Skelly, J. P., and Zenie, F. H. Paperless Laboratories - They're Inevitable! 5 (4) 100-104, Winter, 2002. Van Buskirk, G. A., González, M. A., et al., Workshop Report: Scale-Up of Transdermal Drug Delivery Systems. Eur J Pharm. Biopharm. 44, 327-331, 1997. Skelly...

2

Nonclinical Drug Development Consulting Services, LLC

http://www.drugdevconsult.com/home.html

Nonclinical Drug Development Consulting Services, LLC. Review of C,M&C sections of INDs, NDAs & ANDAs. Expert opinions of scale-up and validation protocols, data, and launch plans. SUPAC consultation and submission strategy. Pre-Approval readiness evaluation and preparation. Expert review of development pharmaceutics reports. Critique of analytical methods and validation packages. Critique of bioanalytical methods and validations. Optimization of dosage form design approaches.

3

Nonclinical Drug Development Consulting Services, LLC

http://www.drugdevconsult.com/cv.html

Glenn A. Van Buskirk, Ph.D. PhD Pharmaceutical Science, Rutgers University, 1979. Master of Science (Pharmaceutical Science), Rutgers University, 1973. Bachelor of Science (Pharmacy), Rutgers University, 1969. Nonclinical Drug Development Consulting Services, LLC 2005 - Present. Established this independent consultancy to provide expertise in product development, scale-up and launch, and SUPAC guidance to the pharmaceutical industry. Specializing in formulation development, analysis and international...

4

Nonclinical Drug Development Consulting Services, LLC

http://www.drugdevconsult.com/companyprofile.html

Glenn Van Buskirk, Ph.D. Glenn Van Buskirk is the Managing Partner of Nonclinical Drug Development Consulting Services (NDDCS), LLC. Dr. Van Buskirk is a seasoned professional with over 40 years of international product development and management experience. His consulting practice specializes in pharmaceutical dosage form design, scale-up, launch, and, post-approval improvements. Dr Van Buskirk holds a Ph.D. degree in Pharmaceutical Sciences from Rutgers University. He is a frequent presente...

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Nonclinical Drug Development Consulting Services, LLC. Review of C,M&C sections of INDs, NDAs & ANDAs. Expert opinions of scale-up and validation protocols, data, and launch plans. SUPAC consultation and submission strategy. Pre-Approval readiness evaluation and preparation. Expert review of development pharmaceutics reports. Critique of analytical methods and validation packages. Critique of bioanalytical methods and validations. Optimization of dosage form design approaches.

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