Regulatory Practices

Customer Support, including preparation, sending to the competent authorities and management until the conclusion.

e-Reg: digital regulatory management

Regulatory Desk: on-line procedures, documents, product data and information in one click.

Technical Documentation

Due Diligence Project and Solution, from digitalization to Base-Line e-CTD.

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 RA activities in support of the customer company business.