KLIFO
KLIFO A/S provides consultancy services to the pharmaceutical industry. The company's services include strategy and feasibility studies, translation and preparation of protocols, packaging, labeling, and registration of pharmaceuticals. It also provides database development and processing, trial monitoring, biostatistical analysis, and clinical reports services. The company is based in Copenhagen, Denmark.
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| KLIFO | |
|---|---|
| Type | Private |
| Industry | Pharmaceuticals |
| Founded | 1994 |
| Headquarters | Smedeland 36 Glostrup, 2600 Denmark |
| Number of employees | 51-200 employees |
History
Founded in Denmark 1994, KLIFO provides clinical trial services for medical products, devices and nutritional products. We have grown into a drug development consulting company with an international client portfolio.
We provide a wide range of consultancy, strategic and operational services within all areas of clinical research, pharmacovigilance, clinical trial supply, regulatory affairs, the development of pharmaceutical and biotech products and the development of medical devices. Our solutions meet each client’s specific needs. [1]
Areas of expertise
- Product development strategies and plans (overall, clinical, preclinical, CMC, regulatory)
- Documents for regulatory purposes (efficacy, safety, quality)
- Documents for planning and decision-making (project plans, TPPs, risk assessments, gap analyses, second opinions)
- Scientific advice/pre-IND (LoQ, briefing documents, facilitate meetings with authorities)
- Due diligence of projects and portfolios
- Interim experts (medical, clinical, preclinical, CMC, QA, biostatistics and regulatory)
- Interim project management, alliance management and R&D management.
Pharmacovigilance Services Offered
- QPPV for clients
- Strategic advice and Liaison with authorities
- Preparation and review of pharmacovigilance document
-CCSIs
-PSURs, DSURs and RMPs
-Data entry and medical assessment of individual case safety reports from various sources, including: -Writing of safety narratives and company comments -Coding of adverse events, medical history and concomitant medication -Assessment of seriousness, listedness and causality -Pharmacovigilance system master files -PV agreement negotiations with partners and subcontractors
Pharmacovigilance procedures management
Reference
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