Our services

We offer you our competent and reliable services and support in the following areas:

• Development and establishment of biopharmaceutical production
• Process optimisation, qualification and validation
• Development and establishment of analytical methods for quality control
• Method qualification and validation (according to ICH Q2(R1))
• Providing expertise in supply of pre-clinical and clinical material
• Transfer of methods and technology; outsourcing
• Selection and auditing of contract manufacturer (CMOs) & analytical service labs (CROs)
• Outsourcing Management - drafting of contracts and negotiations
• Project management - portfolio management - interims management
• Creation, reviewing and/or updating technical documentation for IND, IMPD ( "eCTD Module 3”)
• Interaction with regulatory agencies, presentations and discussions  (international)

If your personal concern is not listed here, please do not hesitate to contact us by phone or e-mail [+49 8153 93 84 04 or: info@hanakam-consulting.com - contact].