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Regulatory Affairs services in the EC
- Strategy review - New applications - Post approval procedures - pricing and reimbursement - Dossier updates - Line extensions - Variations - Licence renewals
Preparation of regulatory documents
- Clinical expert & Pre-clinical expert & Pharmaceutical expert reports - SmPC - PSURs
Prepared according to the current EC requirements,
- up-to-date information - highest scientific standards.
Main therapeutic areas: oncology, infectiology, emergency medecine.
Extensive experience in clinical research: - protocol development, - case record form design, - database development, - investigator selection, site initiation - monitoring - data cleaning - audits
Whether you require assistance with a small part of a trial, assistance in turning around trials that are behind schedule or want us to run an entire programme, talk to us.
Activity:
- Clinical Trials
- Licensing & Business Development
- Regulatory Affairs & Legal Services
- Research & Development
- Other Industry Services
Product / Technology type(s) covered:
- API / chemicals
- Cosmoceuticals
- Curative
- Devices
- Drug delivery
- Generics
- FP (finished products)
- NCE (new chemical entities)
- OTC (over the counter drugs)
- Pharmaceuticals / Therapeutics
- Phyto
- Nutritionals / Vitamins
- Prescription drugs (Rx)
- Preventive
- Technology
Therapeutic targets:
- Aging
- AIDS
- Allergy
- Arthritis / Rheumato
- Asthma
- Cancer
- Cardiovascular
- Central nervous system
- Cough / Cold
- Dermatology
- Diabetes
- Gastrointestinal
- Geriatrics
- Hematology
- Infectious Diseases
- Men's Health
- Mental Health
- Neurology
- Obesity
- Oncology
- Ophthalmology
- Pain
- Pediatrics
- Reproductive Health
- Respiratory Medicine
- Stroke
- Tonics
- Urology
- Women's Health
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