Welcome to Riley and Rabel Consulting Services

What We Do

Preformulation, Pharmaceutical and Analytical Development

  • Preformulation, including Discovery Support for Lead Optimization
  • Pre-clinical Formulation Development
  • Phase 1 and 2 Clinical Supplies
  • Full Development and Technology Transfer
  • Integrated Pharmaceutical Development Plans
  • Method Development and Validation
  • Method Transfer
  • API Characterization
  • Impurities Qualification and Specification
  • Specification Development
  • Stability
  • Dissolution

CMC Strategy, and Compliance

  • Design of CMC Development Plans
  • Interpretation of CMC Regulations
  • Project Management and Review
  • Writing and Review of Regulatory Submissions
  • Integrated Quality Systems
  • SOPs, Guidelines, Best Practices, Training Manuals and Training Programs
  • Writing and Review of Technical Reports

Patent Litigation

  • Patent review
  • Expert Report Writing
  • Sworn Depositions and Testimonies


Contact Us

Have Questions?

Feel free to reach out and get in touch.

Riley and Rabel Consulting Services

1055 Forest Street, Maryville, MO 64468, US

(660) 530-4252

Hours

Monday - Friday: 8am - 5pm 

Saturday - Sunday: Closed

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About Us

Christopher Riley, Ph.D.

Christopher Riley is the President and Co-founder of Riley and Rabel Consulting Services, LLC. Dr. Riley received his bachelor’s degree in pharmacy (1977) and Ph.D. degree in Pharmaceutical Chemistry (1980) from the University of Bath, England. He was a post-doctoral fellow at the University of Kansas in the Department of Pharmaceutical Chemistry (1981-1982) before joining the faculty of the Department of Pharmaceutics at the University of Florida. He returned to the University of Kansas as a faculty member in 1986 where he remained until 1994.

Dr. Riley’s industrial experience began in 1994 as head of Analytical R&D at Dupont Pharmaceuticals (previously Dupont Merck). In late 2001 he joined ALZA, a subsidiary of Johnson & Johnson, where he had positions of increasing responsibility up to Vice President and West Coast Site Head ChemPharm Development. He left ALZA in May 2007 to form Riley and Rabel Consulting Services. He has co-authored more than 100 book chapters and papers in peer-reviewed journals, as well as two books entitled Pharmaceutical and Biomedical Applications of Liquid Chromatography and Validation of Methods and Systems in Pharmaceutical and Biomedical Analysis. He was elected Fellow of the American Association of Pharmaceutical Scientists (AAPS) and served as the chair of the Analysis and Pharmaceutical Quality Section of AAPS and a Member of the AAPS Executive Committee. Dr. Riley has served as a member and chair of the PhRMA Analytical Technical Committee, as well as a member and chair of the PhRMA Technical Leadership Committee. Dr. Riley represented PhRMA on the ICH Expert Working Group on Impurities in Drug Substances (Q3A) and Drug Products (Q3B) and was Chair of the PhRMA Working Group on Genotoxic Impurities.

Shelley Rabel, Ph.D.

Shelley Rabel is the Vice-President and Co-founder of Riley and Rabel Consulting Services, LLC. Dr. Rabel received a B.S. in Chemistry from Northwest Missouri State University in 1988. She then received a Ph.D. in Pharmaceutical Chemistry from the University of Kansas in 1994, where she was awarded a USP Fellowship and a Training Grant Fellowship with the National Cancer Institute.

Dr. Rabel has over 12 years of experience in the pharmaceutical industry. She started her career at DuPont Pharmaceutical Company (now Bristol-Myers Squibb) in the Basic Pharmaceutics and Biopharmaceutics group providing Preformulation/Formulation support for Discovery and Pharmaceutical Development groups. In 2002, Dr. Rabel joined ALZA Corporation, a subsidiary of Johnson & Johnson, as a Principal Scientist/Manager in Oral Products Development where she was responsible for the development of controlled-release dosage forms. In 2005, she accepted a position with Amgen, Inc. as Associate Director of Small Molecule Pharmaceutics at the San Francisco site. In this role she led the start up and integration of a new Pharmaceutics group, which provided Preformulation support for multiple projects and therapeutic areas. In May of 2007, Dr. Rabel co-founded Riley and Rabel Consulting Services, LLC. Dr. Rabel has nineteen publications, seventeen presentations, and three patents.

Fully Integrated Product Development Teams

Riley and Rabel … has developed strong collaborative relationships with other CMC consultants as well as in all other areas including nonclinical, clinical, regulatory affairs, project management, and technical writing.  Through these collaborations we can put together teams or sub-teams of highly experienced scientists that support all phases of product development.

Publications

Publications

Rabel Riley, S.R. An Integrated Approach to the Analysis of Pharmaceutical Solids. J. Chem. Ed. 2015, 92(5), 932 – 935.

Riley, C.M.; Rabel Riley, S.R.; Phelps, R.L. Assay and Impurities. In Specification of Drug Substance and Products: Development and Validation of Analytical Methods; Riley, C.M., Rosanske, T.W., Rabel, Riley S.R., Eds.; Elsevier: Oxford, UK; pp 109-142 (2014).

Rabel Riley, S.R.; Vickery, R.D.;  Nemeth, G.A.;  Haas, M.J.; Kasprzak, D.J. Maurin, M.B.  Thermal Decomposition of Matrix Metalloproteinase Inhibitors; Evidence of a Solid State Dimerization.  J. Pharm. Biomed. Anal. 2011, 54, 324-330. Murphy, D. and Rabel, S. Thermal Analysis and Calorimetric Methods for Characterization of New Crystalline Forms. In: Preformulation in Solid Dosage Form Development; Adeyeye, C., Brittain, H., Eds.; Informa Healthcare USA, Inc.; New York, NY, 2008, p 279 – 322. Shanbhag, A.; Rabel, S.; Nauka, E.; Casadevall, G.; Shivanand P.; Eichenbaum G.; Mansky P. Method for screening of solid dispersion formulations of low-solubility compounds—Miniaturization and automation of solvent casting and dissolution testing. Int. J. Pharm. 2008, 351 (1-2), 209- 218. M. Andino, D. De Antonis, C. Beels, J. DeGeorge, F. De Knaep, D. Ellison, J. Fagerland, R. Frank, B. Fritschel, E. Harpur, C. Humfrey, G. Mohan, A. Jacks, N. Jagota, J. Mackinnon, R. Mauthe, L. Mueller, D. Ness, M. O’Donovan, C. Riley, M. Smith, GlaxoSmithKline; G. Vudathala, L. Yotti, Rationale for Determining, Testing and Controlling Specific Impurities in Pharmaceuticals that Possess Potential for Genotoxicity, Regulatory Toxicology and Pharmacology. 2006, 44: 198-211 Stephen P. Raillard, Joel Bercu, Steven W. Baertschi and Christopher M. Riley, Prediction of Drug Degradation Pathways Leading to Alerts for Potential Genotoxic Impurities, Organic Process Research and Development, 2010, 14: 1015-1020 Hanlin Li, David Nadig, Andrew Kuzmission and Christopher M. Riley, Prediction of the Changes in Drug Dissolution from an Immediate-Release Tablet containing Two Active Ingredients using and Accelerated Stability Assessment Program (ASAPprime®), AAPS Open, 2016, 2(1): 7. Doi:10.1186/s41120-016- 0010-5.

N. Buyktimkin, S. Buyktimikin, J. Singh, J.M. Newsam, D. King-Smith, E. Kisak, B.S. Galer, T. Desai, and C. Riley, Pharmaceutical Formulations and Methods of Use, US Patent Number 2012/0214874, 2012

Impurities in new drug substances (ICH Q3A(R2)) and drug products (ICH Q3B(R2)) as a member of the expert working group on impurities of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2006)  

AAPS Open

A randomized, open-label study assessing the bioequivalence of two formulations of Fingolimod 0.5 mg in healthy subjects


Mario Tanguay, Thomas Fröhlich, Mathieu Drouin and Gerald Beuerle

Stability challenges not addressed by harmonized guidance – AAPS workshop of the stability focus group, April 3rd- 4th, 2017 in Rockville, MD


Mohd M. Khan, Bowen Jiang, Anthony Mazzeo and Kim Huynh-Ba

Assessment of clinical immunogenicity of inotuzumab ozogamicin in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia


Darshana Jani, John Nowak, Ying Chen, Joseph Boni and Boris Gorovits

Comparison of rates of nausea side effects for prescription medications from an online patient community versus medication labels: an exploratory analysis


David A. Blaser, Stephanie Eaneff, James Loudon-Griffiths, Stephanie Roberts, Paulina Phan, Paul Wicks and James Weatherall

Plasma modification of microporous polymer membranes for application in biomimetic dissolution studies


Michael M. Puppolo, Justin R. Hughey, Bruce Weber, Traciann Dillon, David Storey, Elizabeth Cerkez and Susan Jansen-Varnum