Regulatory Affairs

You are responsible for a Regulatory Affairs Department; as a qualified/responsible Pharmacist, you manage:

• The recording of activities
• Regulatory administrative activities: importation authorizations, Authorization of Temporary Use, requests for clinical trial authorization, etc.

The Responsibilities of the "Exploitant" Pharmaceutical Site

You are a qualified/responsible pharmacist for a "Exploitant" Pharmaceutical Site:

• Do you have the required regulatory system for an inspection?
• Do you have all the procedures that are relevant to the pharmaceutical responsibility, such as: the validation of promotional elements, drug samples, DMOS, scientific information, self-inspections, claim handling, pharmaceutical stand-by services?
• Are your processes monitored and optimized?
• Do you use a risk management approach and methodology to identify and minimize risks: risk analysis, risk review, batch recall exercises, contingency plans?
• Do you, or does someone else, conduct self-inspections or internal audits?
• Do you train concerned staff in a pertinent way and document it?
• Are all relevant activities documented in the correct way?

SUNNIKAN Consulting can help you to:

• Prepare yourself for an inspection of your "Exploitant" Pharmaceutical Site
• Write procedures that will fall within pharmaceutical responsibilities, the regulatory administrative activities, and recording activities
• Conduct internal audits in order to optimize your processes and answer to self-inspection regulatory duties
• Update the Public Health Code references in your documents
• Set up a document management database