Areas of expertise
Project management (since 1996) Development of medicinal drug products and medical devices (international and local)
|
Pre-clinical studies (1996-1998) In vivo biodistribution and PK studies
|
Clinical studies (since 1997) Phase I to IV studies
|
Post-approval studies (since 2002) Non-interventional studies
|
Regulatory compliance (since 1996)
|
Medical writing (since 2005) Contract writing for the pharmaceutical and associated industry
|
Quality assurance Good Clinical Practice (GCP) (since 1997) Good Manufacturing Practice (GMP) (2009-2011) Good Distribution Practice (GDP) (since 2012) |
Indications and treatments
Area | Indication | Treatment methods |
---|---|---|
Cardiology | Coronary heart disease, restenosis, atherosclerosis, venous insufficiency | Stenting |
Dermatology | Neurodermitis | Transdermal delivery of macromolecular drugs, biologicals |
Immunology | Allergic rhinitis | Hyposensitisation |
Infectiology | MRSA | Antiinfective therapy, ocular infection prophylaxis, urethral infection prophylaxis |
Metabolism | Homocysteinaemia, diabetes | Drug treatment |
Nephrology | Renal failure | Dialysis |
Neurology | Migraine, post-operative/chronic pain | Pain management |
Ophthalmology | Cataract | Intra-ocular lenses IOL |
Pneumology | Asthma, COPD | Inhalation |
Rheumatology | Rheumatoide arthritis, osteoarthritis | Drug treatment |
Detailed experience list available upon request.