Providing Science-Based Solutions For The Pharmaceutical Industry

Providing Science-Based Solutions For The Pharmaceutical Industry

Services Fully Integrated Product Development Teams

In addition to providing individual CMC consulting based on their extensive academic and industrial experience, Riley and Rabel have developed a significant network of seasoned consultants in all areas of pharmaceutical development. Therefore, we can assemble a team of experts that design, manage and implement a program to take products through all the stages of development from the discovery/development to commercialization.

We have established relationships with other consultants with specific expertise in the following areas:

  • Solid-state characterization
  • Pre-formulation
  • Formulation Design (including oral, topical, inhalation and parenteral)
  • Quality by Design and Design of Experiments
  • Development of Critical Quality Attributes and Specifications
  • Design of Stability Studies and Statistical Analysis
  • Scale Up and Process Validation
  • Analytical Development, Validation and Transfer
  • Regulatory Strategies
  • Pre-approval Inspection Readiness and Training

Our extensive network also includes experts in:

  • Nonclinical toxicology
  • Pharmacokinetics and drug metabolism (nonclinical and clinical)
  • Clinical pharmacology
  • Clinical development
  • Regulatory affairs (CMC, nonclinical and clinical)

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