Your gateway to Swiss technology
Within the framework of an API Project, Dolder Pharma Business Development offers comprehensive services. Among them regulatory support, patent investigations and independent GMP audit reports.
- Regulatory Support
Elaboration and evaluation of Active Substance and US-Drug Master Files (ASMF & DMF), Quality Overall Summary (QOS) and Certificates of Suitability (CEP)
Escort of registration procedures (MRP, DCP)
- Patent Investigations
Evaluation of possible patent infringements supported by patent lawyers registered with the European Patent Office (EPO)
- Neutral GMP Audit Reports
Reliable inspection by means of 3rd party audits conducted by auditors of the APIC audit team.
- Analytical Support
Structure elucidation
Method development and transfer
- Reference Substances
Substances listed in leading pharmacopoeas, though not available through EDQM and USP
- Polymorphy (in cooperation with external partners)
Identification of polymorphic forms
Evaluation towards patented polymorphs
Your contact
Dr. Christian Schulz
Business Team Leader
Pharma Business Development
Tel: +41 (0)61 326 62 31
Fax: +41 (0)61 326 62 04
eMail
Information Brochure (PDF)
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