FOCUSED UNIT ASSEMBLED WITH LOCAL REGULATORY EXPERTS WITH A TRULY EUROPEAN REACH.

At Pivotal we understand that critical to any trial’s success will be the implementation of a comprehensive and integrated regulatory strategy within an increasingly regulated, complex and changing environment. To accomplish this we have established a focused and experienced Regulatory and Start-Up Unit that will develop a sound regulatory approval plan to accelerate all administrative and logistics processes. We serve as a central regulatory document and approval repository and as the liaison between all the regulatory bodies and Ethics Committees and our clients.

Our staff is local experts in the culture and expectations of the regions. They have broad therapeutic expertise and experience, while understanding the regulatory rigor required when running clinical studies. We offer our clients access to our established relationships with international clinical sites. The team is located in our main office in the EU (Madrid) and, in addition, Pivotal utilises a well established network of international employees and consultants throughout the region.

Services we provide:

• Compiling IMPDs
• Preparing and filing clinical trial applications
• Multi-country regulatory affairs knowledge, submissions and effective follow-up
• Strategic planning and oversight of all regulatory activities
• Manage clinical trial agreements with sites
• Translating and back-translating clinical trials applications into multiple languages
• Expedite local patient insurance
• Advise on correct labeling of IMPs
• Obtain import/export licences
• Legal representative services in the EU
• Voluntary Harmonisation Procedure (VHP) submission process

We manage our client’s trial submission through validation, assessment and approval and we support them through all negotiations allowing them to overcome administrative hurdles. We design an ad hoc package of services to meet our client’s particular requirements.