KBJ Pharma

Consulting Services offered:

KBJ Pharma assists pharmaceutical companies in all issues concerning Quality Assurance. We have a general expertise within QA, which we would be happy to offer for your projects. In particular we are dealing with:

Quality Assurance:

Assistance in implementing a quality system or elaboration of a Quality Manual or a Site Master File.
Assistance in conducting Audits at contract acceptors, assessment of new collaboration partners, whether manufacturers in accordance with good manufacturing practice, GMP, or distributors in accordance with good distribution practice, GDP.
Assessment of your own GMP level in relation to Inspection preparedness can be conducted during Mock Inspections.
Assistance in elaboration of Standard Operating Procedures, SOPs, and supporting manufacturing documents.

Legislative matters:

KBJ Pharma is updated in current legislation concerning control of medicinal products and is able to assist manufacturers and distributors in legislative questions to ensure the company is working in compliance.

In-house training in GMP:

KBJ Pharma offers in-house training in GMP for all employees. Individual training courses are elaborated in accordance with your own quality system in order to fulfil current requirements.

Postgraduate training in GMP:

KBJ Pharma offers postgraduate training in all aspects of GMP concerning medicinal products, investigational medicinal products or Active Pharmaceutical Ingredients, APIs. Training courses are prepared in co-operation with you in order to obtain the best results.