Strategic consulting

Strategic consulting

Strategic pharmaceutical affairs consulting, interaction with Health Authorities with successful projet cases on OTC switching, tailored services of fully set up EU Marketing Authorisation Holder.

Strategic pharmaceutical affairs consulting

Strategic pharmaceutical affairs consulting

It is vital to build your house based on good structural plans and start from a solid foundation, so we believe it is essential to prepare a robust and comprehensive strategic plan for all your projects to ensure we can offer you a fast, cost effective and market competitive solution. Our Centre of Excellence combine all key disciplines to contribute to a complex market access strategy from regulatory affairs, pharmacovigilance to quality assurance with own EUBRS or certified GDP warehouses strategically located to ensure coverage of all countries.

All our strategic plans are prepared by leading pharma professionals where all of them have more than 15 years of experience within industry, so we will be well beyond 100 years for each project team.

Our aim is to provide you with comprehensive service – A to Z at one place.

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Scientific Advice - Health Authorities

Scientific Advice - Health Authorities

No matter how comprehensive your plan can be, to interact with Health Authorities is an essential step in your product development, we are an experts in interaction with Authorities in EU, US and Asia. We will help you to prepare Authorities briefing packs for your clinical development and also for your RA market strategy and plans, our experts have enormous experience preparing and attending meetings with Health Authorities on behalf of our client or as your supporting team, whatever will suits your needs.

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OTC Switches

OTC Switches

Our experts filed first OTC switch more than 15 years ago for one of the key OTC product within EU, success of such project rely on excellent knowledge of legislation, presentation and interpretation of clinical data, as well as safety data, and last but not least a confident presenter to the Health Authorities, again another project where A to Z in pharma is essential and we are able to offer these with reference of successfully finalised projects

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Marketing Authorisation Holder Services

Marketing Authorisation Holder Services

MAH services is a complex task where you can be absolutely sure that in case of Vizen a team of experts ensure that EU QP PV/Deputy of EU QP PV, medics, RA Specialist, QA Specialist, EU BRS and all other essential functions are in place to provide you with tailored made services to address exactly your business needs for as long as you require.

We are also preferred service provider in area of RA and PV by many leading distributors so support with marketing of your product if required can be also provided.

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