Hanakam-Consulting
Our Services
We are happy to offer you our competent and reliable services in the following areas, i.e. you receive support with:
- Development and establishment of biopharmaceutical production processes
- Process optimisation, qualification and validation
- Development and establishment of analytical methods for quality control
- Method qualification and validation (according to ICH Q2(R1))
- Provision of pre-clinical and clinical trial material
- Technology and method transfer; outsourcing
- Selection and auditing of contract manufacturers (CMOs) and analytical laboratories (CROs)
- Outsourcing management – contract drafting and negotiations
- Project management – portfolio management
- Creation, review and/or updating of technical documentation for IND, IMPD, MAA, BLA ("eCTD Module 3")
- Presentation and discussion of documents with authorities (international)
Should you not find your specific need listed here, please do not hesitate to contact us by phone or e-mail.