Site Master File & QMS

Whether completely outsourced or managed in house, each Manufacturer is required to maintain and constantly update their Site Master File. Preparing afresh or keeping it constantly updated, complying with EU GMP or PICs, our team constantly works on keeping this document updated at all times in line with your SOPs and various guidelines.

Our team excels in ensuring an effective assessment of Change Controls and ensuring you do not get any objections from FDA on your processes.

Finished Product Specifications

Specifications of the product are one of the most scrutinized document by FDA worldwide. Ensuring the specs are designed in a manner that ensure easy passage through regulatory scrutiny, are compliant with the relevant pharmacopoeia and also keeping manufacturing cost in checks ensuring you stay competitive.