- MA
maintenance
procedures
- Regulatory
submissions
(National applications, Classification,
Variations, Parallel Import,
MA transfers, Compassionate use)
- Notifications
for
Medical
Devices
and Food
Supplements
- Local
Support
in MRP and DCP
- Review
and updates/approvals
of product
information
- Approval
and review
of promotional
materials
- Acting
as
MA Applicant
in National
Procedure
- Harmonization
of regulatory
documents/submissions
on Baltic level
- Clinical
Trial
Applications
- Regulatory
review and consulting - regulatory
documentation compliance review
- Negotiations
and consultations
with
National
Authorities
- Strategic
analysis and consultancy for selection of the optimal regulatory strategy
- Regular
updates on national regulatory legislation changes