Consultation and expert services for pharmaceutical, medical device and cosmetic companies. The company contributes to your success from innovation to market in Europe, Asia and the USA.
- Over 25 years experience in working for international pharmaceutical and life science companies.
- Several products developed from laboratory to the market in Europe, the USA and Asia the including innovative products, generic products and CE-marked products.
- Experience and key competencies:
- R&D
- R&D strategies
- preclinical-, pharmaceutical-, analytical- and clinical development and documentation
- preclinical- and clinical supplies
- regulatory strategies and documentation
- Business Development
- product planning
- feasibility studies
- partner identification
- in licensing and out licensing
- partneships and KOL networks
- Commercialization phase
- scale ups and process validations
- technology transfers
- commercial manufacturing
- market access and marketing
- product strategy
- Quality systems incl. GLP, GCP, GMP, COSMOS
- Project management
Examples of available services
- Strategic planning
- Business development
- Partnering
- Product planning
- Feasibility assessments
- R&D strategies
- Regulatory strategies
- Project management
- Support to pharmaceutical companies to enter markets in Europe and the USA
- Formulation development
- Regulatory documentation
- Technology transfers
- Process validations
- Clinical supplies
- Laboratory analysis for various
purpose
- REACH consultation
- REACH authorizations
- GMP/GLP/GCP (EU, US, JP) incl.
- Mock audits
- Documentation
- Validations
- SOPs
Lay out planning
- QC and QA
- Other GxP compliance
We build a service package to meet the needs of our customers.
