From concept to plan

Zwiers Regulatory Consultancy integrates regulatory intelligence information and health authority requirements into a strategic plan, ensuring that requirements in the complex regulatory framework will be met.

Regulatory Intelligence

In the increasingly complex world of pharmaceutical regulations, it is crucial to filter, analyze and focus on the information relevant to your specific product. Our sources include regulatory agencies, scientific meetings, and literature and competitor data. We use our knowledge and experience to ensure you receive the correct information to suit your product needs.

Moreover, it presents the regulatory pathway to successfully bring your product to the market, taking health authority interactions and life cycle management into account.

Regulatory Strategy Plan

We combine our intelligence information and your company's goals to create a strategic plan for your product. The plan provides an overview of the characteristics of the compound and the development program. Moreover, it presents the regulatory pathway to successfully bring your product to the market, taking life cycle management into account.

We are experts in determining the key regulatory opportunities and challenges. We explore all possibilities in the acceleration of the project planning. Additionally, we help to define the regions for registration and the appropriate regulatory procedures in the plan.

Planning and timelines

Regulatory input is crucial in process and project management. We calculate and advise on the impact of regulatory procedures on your planning. Moreover, we take care of all onerous paperwork and administration that comes with every regulatory step you take.
Furthermore we take into account the specific product characteristics and the intended indication, for example, the required (pre)clinical studies to be performed and the size of the population database.  This helps to determine realistic deadlines.

Pediatric Investigation Plan

A pediatric investigation plan must be present in all new drug applications. Zwiers Regulatory Consultancy evaluates the potential need for pediatric development, develops a strategy and writes the accompanying PIP. We will support interactions with health authorities and pediatric committees.

If you need our help with any of the above, please contact us. We'll get back to you as soon as possible.