|
Robert J. Russell
President, RJR Consulting, Inc. As President of RJR Consulting, Inc., Bob Russell has 28 years of past industry experience as R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow and Cordis-Dow. With a BS / MS in Chemistry, Bob’s main areas of expertise include: - Strategy Development
- Regulatory Compliance Pharmaceuticals / Biologics
- Regulatory Compliance Medical Devices / Combination Products
- Technical Writing: Trial Protocols
- Marketing Authorizations
- Manufacturing Authorizations
- Inspections / Audits
RJR Consulting, Inc.
With offices in Columbus, OH, Washington, DC and Brussels, Belgium, RJR Consulting, Inc. assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance.
Areas of specialization include: - Authorized Rep. / Legal Rep. in EU
- Strategy Development
- Clinical Trial Set-Up
- Marketing Authorizations
- License Renewals
- Variations / Amendment Filings
- Manufacturing Authorizations
- Drug Master Files
- Certified Medical Writing
- CRO Management & Selection
- Inspection Assistance / Pre-Audits
- Government / Agency Regulatory Affairs
- Training
- International Regulatory Surveillance Updating: NA, EU, Japan, LAA
Upcoming Web Seminars hosted by Robert: |
