SERVICES

Pharma Action's core competence is the management of active pharmaceutical
ingredients.

We offer customized solutions from optimizing procurement processes and results to reengineering of the entire value creation alongside your supply chain.

Once your procurement strategy is defined, Pharma Action will carry out the
implementation on your behalf.



API PROCUREMENT

• Allocation and selection of APIs / manufacturers

• Price negotiations and Total Cost of Ownership optimization

• Operational procurement management and logistics

• Preshipment inspections and sampling

• Realization of a lean supply chain: supplier consolidation, just-in-time concepts, vendor-managed inventory

• Taking over full or part procurement processes: by category, by purchasing volumes and / or supply markets

• Redesigning existing procurement processes

BUSINESS DEVELOPMENT

• Market research

• Market entry and marketing strategies

• Identification of marketing partners

• Business intelligence and market surveillance

• Competence networks in the major API procurement markets: India and China

VIRAL SAFETY STUDIES FOR APIs

Our experts carry out virus (process) validation studies in compliance with the latest EMEA and FDA requirements.

The cGLP-laboratories operate on biosafety level 2 & 3.

Our services include:

• validation of the manufacturing process (process validation)

• virological testing of cell lines (Master and Working Cell Banks)

• testing pharmaceuticals intended for use in gene-therapy trials to ensure they are free from replication competent viruses (RCA and RCR)

DRUG MASTER FILES IN CTD FORMAT !

From May 1st 2005 the new CTD-format for both open and closed part of your DMFs became compulsory !

We offer through our experts for regulatory affairs to revise and update your DMFs for any pharmaceutical substance.

Please check with us for details and prices.


CONTRACT MANUFACTURING

Due to our excellent contacts through out the pharmaceutical world, we are pleased to offer the finishing of our API`s through first class and state-of-the-art contract manufacturers. Please check for more details.


SOURCING OF API`s

Apart from the offered specialities we are able to identify and source active ingredients for your production. Promptness and product reliability characterize our service best.