Dossier Preparation and Submission

Back office support in regulatory affairs for regulated markets including product development dossiers and Intellectual Property Rights to pharmaceutical companies.
Expertise in dossier compilation and submission for global Pharma Clients.
Meticulous review of the dossier ready-for-submission and support in regulatory due diligence.
Team of qualified, lead auditors certified with experience from several multinational companies (MNCs) with technical expertise to ensure vendor compliance to ICH, ISO. UK-MHRA, MCC, TGA etc., in-house or other standards as required.
Adept in e-communications and e-submissions and adherence to 21CFR11.

Expertise