To offer a full service to pharmaceutical companies, we work in partnership with OP-Pharma – Regulatory Affairs Outsourcing and Consulting which since 1996 works with important pharmaceutical Italian, European and extra UE Companies by providing them with technical-administrative and regulatory services.
REGULATORY PRACTICES
Customer Support, including preparation, sending to the competent authorities and management until the conclusion.
E-REG: DIGITAL REGULATORY MANAGEMENT
Regulatory Desk: Online procedures, documents, products data and information in one click.
TECHNICAL DOCUMENTATION
Due Diligence Project and Solution, from digitalization to Base-Line e-CTD.
OP PHARMA E-DOX SOLUTIONS
eCTD Management, Submission and safe Sharing of eCTD sequences.
CONSULTING
AIFA and Italian Ministry of Health Power Of Attorney: intermediation and problem solving.
OUTSOURCING
OP Pharma is able to carry out all the Regulatory Affairs activities in support of the customer company business.