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.  Our pharmaceutical regulatory consulting services include but are not limited to:

• 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

• Review of regulatory literature
• Training on global pharmaceutical regulatory compliance
• Legal/Authorized representative in the United States, Canada, European Union (EU), Latin America and Southeast Asia
• Clinical Research Organization (CRO) management
• Provide regulatory surveillance updates

• 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
• Investigational Device Exemption (IDE) applications
• Biological license applications
• Orphan drug designations
• Combination products (Device plus drug)
• 21 CFR Part 11 Compliance

• 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