To provide a comprehensive and integrated service to pharmaceutical and biomedical companies, we partner with OP-Pharma,, a company specializing in outsourcing and regulatory consulting. With over 20 years of experience, OP-Pharma supports some of the leading Italian, European, and non-EU pharmaceutical companies, delivering high-level technical, administrative, and regulatory services.
REGULATORY AFFAIRS
Support, preparation, submission to the relevant authorities, and management through to completion.
E-REG: DIGITAL REGULATORY MANAGEMENT
Regulatory Desk: Online processes, documents, data, and information available at a single click.
TECHNICAL DOCUMENTATION
Due Diligence projects and solutions, from data conversion to baseline development.
OP PHARMA E-DOX
eCTD Management, Submission and Sharing for the secure handling and exchange of eCTD sequences eCTD.
CONSULTING
AIFA and Ministry of Health representation: liaison, mediation, and problem solving.
OUTSOURCING
OP Pharma is able to carry out, on behalf of third parties, all activities supporting the company’s core business.