Service

A pharmaceutical consultancy offering a range of services

Site license support

Assistance in the preparation and application for a new site license (MIA).

Inspection support

Support when preparing for a regulatory inspection.

Audit ready support

Help in attaining and maintaining an audit ready state to eliminate the last minute confusion prior to inspection.

General advice

Advice on issues such as good manufacturing practice, regulatory compliance, contract manufacture, cold chain, import, active pharmaceutical ingredients and sub-contracting.

Supplier auditing support

Supplier auditing; API, excipient, contractors and suppliers.

Supplier auditing support

Qualified Person batch release of manufactured and imported products.

Product license support

Assistance in reviewing the requirements which need to be taken into account in order to consolidate product licenses across multiple countries.

Pharmaceutical Quality System support

Creation, maintenance and update of your pharmaceutical quality system for your manufacturing, supply and distribution of medicinal products.