Drug Development Management
and Regulatory
Services
RRI Group is a Full Service Global Regulatory and Management Company that collaborates with pharmaceutical, device, and biotech companies in the development of novel branded and generic therapeutics and devices.
Strategic Business and Product Planning Feasibility Pre-IND Market Intelligence Market Research Product Acquisitions & Licensing Product Development Alliances Program Evaluation & Coordination Outside Project Funding Non-Clinical and Technology Evaluation
CLINICAL PROJECT MANAGEMENT
Proof of Concept Studies Pilot/Pivotal Studies Clinical Protocol Development Clinical Pharmacological Review Clinical Documentation & Report Development Clinical End Point Trial in Patient Populations Statistical Design for Protocols CRO Quotation Management & Selection Project Tracking & Oversight Safety Evaluations Literature Biostatistical Analysis Investigator Meeting Set-up and Management
REGULATORY/ PROJECT MANAGEMENT
Project Identification & Evaluation Project Feasibility Pre-IND Meeting Package Bioavailability/Bioequivalence Pilot/Pivotal Studies Regulatory Path Development Safety Evaluations Literature Biostatistical Analysis Investigator Meeting Set-up and Management
SUBMISSION PREPARATION
Regulatory Submission and Preparation Review and Coordinate with FDA for: Pre-IND Preparation Pre and Post IND Meetings IRBs and Ethical Committees ANDAs INDs Bio INDs CBE30 PAS 505(b)(2) NDA 510(k) (Device Application) DMFs Non-Clinical & Toxicology Review CMC Preparation & Review Medical Writing
AUDITS
Site Quality Audits Site Monitoring Biostatistical Analysis GLP Audits GCP Audits CMC Reviews GMP Inspections QA Training
TECHNOLOGY TRANSFER
Research and Review Intellectual Property Rights Regulatory Review Agreement Negotiations Market Penetration Analyses Trade & Government Relations Importation and Approval of Foreign Products
CLINICAL PROJECT MANAGEMENT
Proof of Concept Studies Pilot/Pivotal Studies Clinical Protocol Development Clinical Pharmacological Review Clinical Documentation & Report Development Clinical End Point Trial in Patient Populations Statistical Design for Protocols CRO Quotation Management & Selection Project Tracking & Oversight Safety Evaluations Literature Biostatistical Analysis Investigator Meeting Set-up and Management
We invite you to contact us about your drug development needs, as well as our cGMP, cGCP and cGLP inspections and auditing services. We can build a foundation for your product development needs.
We invite you to contact us about your clinical trials, drug development needs, as well as our cGMP, cGCP
and cGLP inspections and auditing services. We can build a foundation for your product development
needs. RRI Group…Helping Companies GROW!
Product Marketing Opportunities
