Our knowledgeable staff produce high quality
safety documentation. We ensure that your documents are compliant
with quality assurance processes and meet required inspection
standards.
We offer:
•
Document production, including
periodic safety update reports (PSURs), annual safety reports,
risk management plans and product labelling
•
Process optimisation for in-house document
production.
Recent projects:
•
Label writing and revision
for mature products
•
Periodic Safety Update Report (PSUR)
review for a number of pharma companies
•
Completion of section 8.4 of a PSUR
as part of risk management implementation for a top
25 pharma company.
