Regulatory Affairs and Pharmacovigilance

Advanced predictive modelling to help you optimise cost efficiency, value-based care, and personalised medicine.

Our Services

Pharmaceutical regulatory affairs

Providing strategic and operational regulatory support to help ensure compliant product registration, maintenance, and lifecycle management across the Baltic region.

Regulatory submissions – National applications, Classification, Variations, Parallel Import, MA transfers, Compassionate use, notifications for medical devices and food supplements.
Regulatory Strategy & Authority Support – Providing strategic regulatory consultancy, compliance review of regulatory documentation, and consultations with National Authorities to support efficient market access.
Product Compliance & Baltic Regulatory Coordination – Supporting the review and approval of product information and promotional materials, harmonisation of regulatory documentation and submissions across Estonia, Latvia, and Lithuania, alongside regular updates on national regulatory legislation changes.
Clinical Trial Applications – Preparation and review of submission documentation, coordination with National Authorities, and guidance on local regulatory requirements to support compliant clinical trial initiation and maintenance.

MRP/DCP Assistance & Local Liaison

We specialise in supporting Mutual Recognition (MRP) and Decentralised Procedures (DCP) where the Baltic states act as Concerned Member States (CMS).

Marketing Authorisation Application (MAA) – End-to-end management for successful validation and maintenance.
Local Liaison – Acting as the point of liaison with the relevant Regulatory Authorities throughout the entire procedure.

Labelling & Product Information

Supporting compliant and market-ready product information, translations, and packaging maintenance.

Baltic language services – local language translations and native speaker checks
Packaging – Preparation of packaging including Baltic package and applications for special permissions
Labelling Management – Review and update of labelling and product information

Pharmacovigilance

We offer a robust Pharmacovigilance infrastructure, providing a Local Responsible Person for Pharmacovigilance (LPPV) to oversee safety data collection and management.

Collection and management of safety data in defined territory
Consultancy on applicable laws and legislation changes relating to Pharmacovigilance
Reporting to EU Qualified Person for Pharmacovigilance (QPPV) nominated by MAH
Weekly local medical and scientific literature screening not covered by international databases
Representing MAH in case of local HA audits

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