VMVO is able to provide you with expert planning, research, regulatory advice, strategic advice, and project management in the pharmaceutical development, and the hospitals sectors. Our high levels of quality and expertise is attained by exclusively engaging seasoned professionals who have at least 25 years of experience in the healthcare and life sciences industries.
We are also able to leverage our wide range of skills to suit the needs of startups in the pharmacology and biomedical sectors.
Our combined skills can assist you with:
Hospitals and Laboratories
· Anesthesiology
· Hospital design
· Hospital management
· Neurology
· Operating room design
Hospital Pharmacies
· Quality Management System (QMS) implementation
· ISO 9001:2000 certification preparation
Pharmacology
Drug development
· Lead compound identification
· Synthesis of new chemical entities
· Development of suitable screening-models
· Development of suitable pathophysiological disease-models
Drug quality and drug safety
· Substance identity, Analysis methods, Galenics
· Pharmacokinetics and metabolism in vitro and in vivo
· Analytical toxicology at cellular level, and in the entire
organism/animal
· Gene toxicity, embryo toxicity, carcinogenic level
· Defined toxicity (as dictated by regulations/law), 26 and 52 week
toxicity
Clinical development
· Filing application documentation, IND (Investigational New Drug
application)
· GCP (ICH)-conforming clinical studies (Phases I-III)
· Planning and execution of multicenter clinical trials (randomized,
double blind, placebo - controlled, prospective)
· Potential drug interaction
· Biometrics, management, analysis of results
· Filing license documentation, NDA (New Drug Application)
Post marketing Surveillance
· Recording unwanted side effects, ADR (Adverse Drug Reactions)
· Pharmacokinetic & pharmacodynamic polymorphism, interactions
· Elaborating the indications for the new drug
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