Services

Pharmaceuticals


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

Whether you’re bringing a 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 consumers.

RJR Consulting, Inc. offers a wide range of pharmaceutical consulting services to meet your specific business needs.  Our highly trained consultants have the experience necessary to move your project forward as efficiently as possible, whether it’s a new drug application, pharmaceutical license renewal or mock audit.  Some of our pharmaceutical regulatory consulting services include:

Clinical product development
  • Clinical strategy development
  • Assistance with creation of product development plan
  • Development of standard operating procedures
  • Development of clinical and non-clinical trial protocols
  • Development of pharmacovigilence programs
  • Partner identification for CRO’s & Analytical labs
Global regulatory affairs support
  • Review of regulatory literature
  • Training on global pharmaceutical regulatory compliance
  • Authorized representative/Agent in the United States, Canada, European Union (EU), Latin America and Southeast Asia
  • Clinical Research Organization (CRO) management
  • Provide regulatory surveillance updates
  • Global Regulatory Intelligence for licensing, registrations, renewals, variations and labeling
  • Pharmacovigilance/ADE reporting and Support Call-in Center
  • Partner identification for contract manufacturers and distributors
  • Manufacturing Related Quality Support: Process validation, cleaning validation, equipment validation and technology transfer
International regulatory documentation submissions including but not limited to
  • New Drug Applications (NDA)
  • Pre-Market Approval (PMA) process
  • Clinical trial dossiers
  • Common Technical Documents (CTD)
  • Marketing Authorizations (MA)
  • Variations & amendment filings
  • Pharmaceutical license renewals including registrations, certifications and product labeling
  • Orphan drug designations
  • 21 CFR Part 11 Compliance
Quality Assurance, Auditing & Inspections
  • Pharmaceutical mock audits
  • Assistance with GMP, GCP & GLP inspections
  • PSM, RMP and SPCC development
  • ISO compliance auditing
  • Risk management auditing
  • Evaluation of quality systems and processes
  • Establishment of a compliance management system

Case Studies

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