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Regulatory Strategy
As regulatory affairs consultants, one of prime areas of expertise is in regulatory submission strategy planning.
To market in more than one territory in the EU, a pharmaceutical company must use either the centralised or the decentralised procedures (either MRP or DCP ) to register a product.
Part of the process is harmonising the generic product Summary of Product Characteristics (SmPC) across all territories, even though the originator SmPC may not be harmonised.
- SmPC Comparisons
- It is a vital part of any company's market planning to highlight all potential areas of contention between Concerned Member States (CMSs). This is typically on issues such as indications, contraindications, dose and posology – all of which are in the SmPC.
- Ivowen Limited can liaise with Health Authorities prior to submission on SmPCs, quality issues, biostudy strategy, etc.
- Ivowen Limited can help your company to devise the best route for product approval in all markets in time for patent expiry.
- Ivowen Limited can advise your company on whether an application for a Paediatric Investigation Plan (PIP) is required or not. Ivowen Limited can also prepare PIPs, waivers to PIPs and PIP deferrals for you company in conjunction with clinical experts with expertise in various therapeutic areas.
- We can also advise on individual countries national requirements, such as EFG status in Spain , the MHRA SmPC fragmentation, samples for The Netherlands, etc.
- Ivowen Limited have been working closely with generic pharmaceutical companies in the new Member States and with current accession countries to bring their documentation and systems up to standard for entry into the EU.
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