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Special services for
pharmaceutical companies
and related industries
 



 
PHARMACEUTICAL PROJECTS


Take advantage of our experience in the following areas:


Engineering and economics

Facility design and layout utilising 3D CAD
Tendering and acquisition of facilities
Assessment of demands
Computer validation
Compilation of requirement specifications
Preparation of presentations
Development of extension strategies
Modernisation and reconstruction
Optimisation of manufacturing pocesses
Product development
Product transfer
Project management
Qualification of facilities
Validation of manufacturing processes
Validation of cleaning processes
Calculation of profitability
21CFR11-compliance implementation

Reorganisation

Analysis and strategy development
Due delegence testing
Calculation of profitability

Quality assurance

Installation, adaptation and updating of quality assurance systems
Compilation of qualification documentation
GMP-analysis and GMP-consultation
In-house training
Change management
Worldwide audit of suppliers

Regulatory affairs


Compilation of documents according to CTD-format
Support in preparing the IMPD documentation (chem.-pharm.part)


 
 
 
   
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