Galenisys Pharmaceutical Consultants
Galenisys is a top-ranking pharmaceutical consultancy with extensive experience working with blue chip pharmaceutical manufacturers in North America and Europe. In order to be close to the market needs, Galenisys USA Inc. has been created beginning of 2017.
We have helped our clients in areas such as resolving regulatory compliance issues, establishing state-of-the-art quality systems, auditing GMP status, dealing with the FDA on CFR issues, obtaining BLA, NDA, IND and DMF approvals and equivalents in both the US and Europe and achieving WHO pre-qualifications.
Our areas of specialisation are:
- Quality Systems – their design and implementation
- Quality and Regulatory Management
- Auditing for Compliance with GMPs, GLPs, GCPs and other regulatory requirements
- Troubleshooting Quality Issues
- Establishing and improving Quality Organisations
- Capital Project Management of new production facilities and production lines
- Staff and Management Training in Quality and compliance
- Qualification and Validation of equipment and infrastructure
Click on any link above to learn more, or contact us directly to speak to one of our consultants.