510k

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.
510(k)
Consultants
Matthew Augustine, PhD.
Topical and Oral Product Formulation and Manufacturing
Teresa T. Jarrett, Ph.D.
Regulatory Medical Writing (IND and NDA submissions)
Robert Milanese
Strategic Business Planning and Product Licensing
Dennis E. Babel, Ph.D., (ABB).
Clinical Microbiology
Mike Jarvill
Preparation of Submissions to the European Union
Barrie M. Phillips, Ph.D.
Clinical Research, Topical BE with Clinical Endpoint and Topical BA
Charles Bon
Biostatistics and Pharmacokinetics
Isadore (Izzy) Kanfer
Emeritus Professor of Pharmaceutics
Lynn Kennard Pershing, Ph.D.
Design and Evaluation of Pre-clinical I n Vitro Studies
H. Joseph Cardenas
Site Audits for Bio Studies & Clinical Studies, Spanish Interpreter and Translator
Herbert G. Luther, PhD.
Regulatory Strategy and Submissions (ANDAs, 505(b)(2), NDA, INDs and per-IND meetings) , Clinical Affairs, FDA Liaison
Leon Shargel, Ph.D.,R.Ph.
CE and BE Protocol Preparation, Pharmacology and Toxicology Consulting
Alex El-Beleidl
Controlled Substance DEA Compliance
Linda Magill
Quality Systems and Regulatory Compliance for Drugs and Devices
Humphrey Tebit
Clinical Study Design and Statistical Analysis
Ron Filler, Ph.D.
Designs Pharmacology and Toxicology Studies and Literature Review
Robert Mazzaferro
Medical Device Reviewer/Engineer
Robert L. Zeid
Regulatory Affairs, Quality Assurance and Technical Writing Specialist
Jean L.Fourcroy, MD.
Regulatory and Compliance
consulting for Drug and Devices
Jairaj (Jai) Mehta
GMP, GCP and GLP Compliance, Sterile Products Specialist
Alan J. Higgins, Ph.D.
Specialized skills in metabolism and cardiovascular diseases, and in multiple other therapeutic areas
Ramakant M. Mhatre, Ph.D.
Pharmacology and Toxicology Reviews, FDA Liasion


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.



Product Marketing Opportunities

Regulatory / Project Management

Clinical Project Management

Submission Preparation

Audits

Technology Transfer



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!

info@rriint.com
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