Knowledge Center

Although getting regulatory information is not an issue today, obtaining proper up-to-date and comprehensive information is still not easy in regulatory area. On the top – the ability to synthesize and leverage on complex information, creates the significant added value in situations where the regulatory environment is challenging, the rules are missing or under development. The main force is knowledge – which is different from traditional support/technical functions. The potential to evaluate different alternatives, suggest the ways to reach the goal and creatively support the project to be successfully navigated through the regulatory “maze” – is the ultimate advantage in turbulent regulatory environment.

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Regulatory Translation Assessment

Regulatory assessment is key tool for set up of regulatory strategy and plan and effective management of regulatory challenges .we will navigate you through:

• Regulatory analysis

• Identification of end-product

• Identification of critical regulatory barriers

• Regulatory assessment of the project

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Regulatory strategy

Based on proper assessment we will help you to understand how to identify the optimal regulatory strategy for your project:

• Identifying the possible regulatory pathways (e.g. When and Where to do What, alternatives)

• Quantifying of alternative approaches

• Definition of suitable partners (consultants & experts, regulatory authorities (member states, centers)

 

Implementation of strategy

You always need to implement the regulatory strategies in practice. Do you need to train your staff or support the knowledge in this area?  REKNOS is here to support you. Not only is the internal role important, the interactions with regulatory stakeholders are important too….. Do you take into account all aspects of regulatory tools? We will do it for you.

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Regulatory plan and management

• Identification and setting of the milestones

• Regulatory risk factors and risk management

• Regulatory timetables – the timelines and the impacts

• Gathering all regulatory issues – coordination across the project

 

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Interactions with regulatory authorities

• Identification of the competent authorities

• Planning, preparing and organizing of the meetings with authorities

• Expert statements

• Scientific advices

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