RJR Consulting, Inc.
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Pharmaceuticals

PHarmaceuticals - Human & Veterinary


Complying with the worldwide rules and regulation set forth by various organizations and governing bodies is a daunting task for any pharmaceutical business. It requires patience, persistence and experience to keep things moving forward.

​Whether you're bringing an new drug to market or going global with an existing drug, this activity presents a series of regulatory challenges, that must be resolved quickly, to avoid delay in getting your product to patients.

We offer the following services in the area of pharmaceuticals

Clinical Product Development
  • Clinical Strategy Development
  • Clinical Trial Dossiers
  • Product Development Pathway
  • Development of clinical and non-clinical trial protocols
  • Medical Writing/CSRs

Global Regulatory Affairs Support
  • Training on global pharmaceutical regulatory compliance
  • Authorized representative/Agent in the United States, Canada, European Union, Latin America, Asia-Pacific, MENA, South Africa
  • Global Regulatory Intelligence for licensing, registrations, renewals, variations, labeling, and on-going updates
  • Pharmacovigilance/ADE reporting and Support Call-in center
International Regulatory Documentation Submissions
  • New Drug Application (NDA)
  • Ex-US Registration
  • Common Technical Documents, CTD formatting and submission
  • Variations & Amendment filings
  • Pharmaceutical license renewals
  • Special Access: Orphan Drugs, Compassionate Use, Named Patient

Quality Assurance, Auditing & Inspections
  • Pharmaceutical mock audits
  • Assistance with GMP, GCP/GLP inspections
  • Risk Management Auditing
  • Evaluation of quality systems and processes
  • Manufacturing related quality support: Process validation, cleaning validation, equipment validation, and technology transfer

To view our case studies concerning our work in pharmaceuticals please click Here

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  • Home
  • About
  • Services
    • Pharmaceuticals
    • Medical Devices & IVDs
    • Biologics
    • Combination Products
    • Dietary Supplements
    • Cosmetics
  • Global Presence
  • Contact