Our expertise


RegPak BioPharma Consulting’s core competence is its ability to apply increasingly complex best practice models, standards and regulations in a manner that delivers significant value to its clients. RegPak BioPharma Consulting has thorough knowledge and understanding of the relevant directives and guidelines that have been issued by ICH, the European, US and other authorities. When you partner with RegPak BioPharma Consulting, you engage a team of experts, each with technical and industry specializations.

SUBMISSION EXPERTISE

CTA Expertise

EU- Austria, Belgium, Bulgaria, Czech Republic, Croatia, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Norway, Poland, Spain, Slovak Republic, Sweden, The Netherlands, UK

EEA/CEE- Russia, Serbia, Switzerland, Turkey, and Ukraine

US-FDA

Asia Pacific- Australia, China, Hong-Kong, India, New Zealand, Singapore, South Korea, Taiwan, Thailand,

Latin America-Argentina, Brazil, Colombia, Mexico, Peru

Others- Israel, South Africa

MAA Expertise

EU- EMEA (Centralized), The Netherlands (National Procedure)

EEA/CEE- Russia, Switzerland, Turkey, and Ukraine

Asia Pacific- Australia, India, New Zealand, Singapore, Taiwan

Others- Israel, South Africa, Tunisia, Turkey and UAE

Scientific Advice

EMEA

EU Member State

Novel Food Scientific Advice

 
THERAPAUTIC EXPERTISE

Oncology, CNS (Migraine, Parkinson’s Disease, Alzheimer’s, Neuropathic Pain and MS), Rheumatoid Arthritis (incl. Psoriatic Arthritis), Gout, IBD (Crohn’s disease and Ulcerative colitis) , Renal Disorders (Renal Biopsy, Transplantation, AA Amyloidosis and Incontinence), Asthma/COPD, Dermatology , Allergy , Diabetes and Infectious Diseases (Hepatitis B, HCV & Otitis Media).
 
 
  HOME  |  ABOUT US  |  CLIENTS  |  SERVICES  |  MEDIA  |  OUR EXPERTISE  |  OPENINGS  |  CONTACT US
© REGPAK. All Rights Reserved   
Site by:
Mantrin