A pharmaceutical consultancy offering a range of services
Assistance in the preparation and application for a new site license (MIA).
Support when preparing for a regulatory inspection.
Help in attaining and maintaining an audit ready state to eliminate the last minute confusion prior to inspection.
Advice on issues such as good manufacturing practice, regulatory compliance, contract manufacture, cold chain, import, active pharmaceutical ingredients and sub-contracting.
Supplier auditing; API, excipient, contractors and suppliers.
Qualified Person batch release of manufactured and imported products.
Assistance in reviewing the requirements which need to be taken into account in order to consolidate product licenses across multiple countries.
Creation, maintenance and update of your pharmaceutical quality system for your manufacturing, supply and distribution of medicinal products.