Following the acquisition of GEA Pharmaceuticals A/S in June 2007, PharmaZell can now offer the development of finished dosage forms as well. Under the new company structure PharmaZell provides a fully integrated approach in drug product development - from API to marketing authorisation - covering:

• Drug Product Development
• Analytical Development
• Bioequivalence Studies
• API R&D Laboratory
• API Multipurpose Production
• Regulatory Affairs
• Intellectual Property
• Project Management
• QA/QC

Drug product development work at PharmaZell focuses on solid dosage forms - with particular expertise in the field of functional coatings and pellets - and comprises:

• Formulation and Process Development
• Manufacture of Clinical Trial Batches
• Scale up/Tech. Transfer to Costumer Sites
• Development and Production Support

The analytical development department is equipped with the following instruments and technologies:

• Chromatography (HPLC, GC, IC)
• Dissolution
• Titration
• Spectrometry (UV, IR)
• All Pharmacopoeia Instrumentation in order to enable and establish
• Specifications (APIs and Drug Products)
• Method Development/Validation/Transfer
• Stability Studies

While clinical studies as such are typically performed by contract research organisations, PharmaZell offers the following services - utilizing HPLC-MS - to support following Phase I related tasks:

• Bioequivalence Studies
• Bioanalytics, Method Development/Validation
• Biometry

Regulatory affairs is represented in the development teams to ensure competent and timely input about latest regulatory requirements and authority practices.
Regulatory affairs provides services within:

• Preparation and Assessment of Regulatory Documentation
   including Drug Master Files
• Adjustment of Regulatory Documentation from Non-EU to
   EU Requirements or vice versa
• Regulatory Procedures
• Regulatory Strategies

 
Pharmaceutical Development
PharmaZell brochure Pharmaceutical Development
Please see also
www.gea-pharma.com
for further information