Pharmacy > Pharma API > Pharma Business Development

Within the framework of an API Project, BIOTECHNICA-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

Tructure 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

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