Interdos Pharma is an independent pharma consulting company, providing services in regulatory affairs, pharmacovigilance, quality affairs and clinical study management for pharmaceutical companies in the field of human medicinal products, nutritionals, herbal products and medical devices.
The services we provide range from specific single tasks to full service arranging all GMP, regulatory and/or pharmacovigilance tasks that need to be performed by a pharmaceutical company, including acting as the Qualified Person (QP and/or QPPV).
Interdos Pharma was established in 1997 and gained a broad experience in all aspects of GMP/GDP/ISO 13485, regulatory affairs and pharmacovigilance.
Our main regulatory services:
- provide European regulatory strategy, in order to obtain marketing authorizations;
- prepare European marketing authorization applications, including publishing in eCTD;
- perform due diligence on marketing authorization applications and advise how to improve the applications in order to obtain a marketing authorization;
- submit DCP, MRP and national applications;
- maintain marketing authorizations / submit variations.
Our main pharmacovigilance services:
- act as Qualified Person or Drug Safety Officer (DSO);
- set up and maintain PSMF (pharmacovigilance system master file) of clients;
- handle adverse events according to current legislation and report the events;
- compile and maintain your XEVMPD (extended EudraVigilance Medicinal Product Dictionary);
- write and submit PSURs (Periodic Safety Update Reports) and RMPs (Risk Management Plans);
- handle inspections from authorities and audits from your customers.
Our main quality services:
- develop a quality assurance system/quality manual in accordance with current GMP and ISO 13485 demands;
- provide services of a Responsible Person (GDP) and Qualified Person (GMP) including batch certification of medicinal products and medical devices;
- handle inspections from authorities and audits from your customers ( GMP, GDP, ISO 13485).