For 30 years, OP Pharma has been carrying out its activity in the pharmaceutical regulatory consultancy sector and is based on electronic management through ad hoc IT tools developed internally. We operate with a strong spirit of corporate cooperation, relying on the long-standing collaboration of skilled local professionals.
Through its regulatory and PoA services, OP Pharma is able to carry out on behalf of third parties all the activities supporting the customer’s business.
Regulatory Affairs is a sector in which bureaucratic and archiving aspects have a certain relevance, from product management and relations with the authorities up to document preparation and text updating.
Regulatory strategy and legal basis
National and European
Variations, renewals, labeling and pricing dossiers
Online data and documents
eCTD Management
Due Diligence, printed materials management and document conversion from the baseline. Secure archiving and submission of eCTD sequences with e-Dox.
Complete management of MA procedures, variations and renewals through national and European procedures. Continuous digital support with the e-Reg platform.
AIFA and Italian Ministry of Health Power. Specialist intermediation, definition of the regulatory strategy and problem solving with the competent authorities.
OP Pharma has been operating in the pharmaceutical regulatory consulting sector for 30 years and is focused on electronic management through dedicated software tools developed internally.
We work with a strong spirit of corporate cooperation, relying on long-standing collaborations with local professional figures.