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Service Details

Clinical Trial Material UK / EU Importation Consultancy

            What information you need and when you need it

            Building and maintaining a Product Specification File (PSF)

            Supporting audits

           

GMP Training

            Review of training / auidt of training,

            Induction GMP training,

            Annual GMP refresher training including assessments and certificates

 

Validation Documentation

            Review / audit of existing documentation

           

Temperature Mapping and Monitoring Consultancy and Service

            Review of current status

            Documentation to support mapping and validation

             Mapping service (for warehouse or cold store)

            Advice on monitoring equipment or working with your existing suppliers

 

Pharmaceutical Product Development Consultancy

            All pharmaceutical forms including sterile product development considerations, analytical    method development

 

Pharmaceutical Manufacturing Consultancy  

            Covering scale-up, technical transfer, planning, supplier interface

 

Pre and Post Licensing Consultancy  

             Unlicensed medicines development, packaging and labelling

             Clinical Trials Supply packaging labelling and logistics

             Prouct supply chain considerations

 

 

if you have a specific requirement please contact us for further discussion