Regulatory Intelligence

Role of Regulatory Intelligence

Regulatory Intelligence relates to the gathering, analyzing, and application of knowledge about regulatory updates to the ever-evolving requirements and guidelines relating to drug safety. Maintaining up- to- date knowledge of Regulatory Intelligence ensures that CROs and Pharmaceutical companies remain compliant with current reporting responsibilities, as well as surveillance requirements and risk management.

Regulatory Intelligence has many practical applications, including:

• Regulatory Compliance
• Drug Safety Monitoring
• Market expansion
• Crisis and/or Risk Management
• Regulatory Audits and Inspections
• Facilitating Market Access

Regulatory Intelligence at ProPharma

Regulatory Intelligence is a key pillar at ProPharma, and aims to simplify compliance, reduce risks, and ensure both ProPharma and our clients stay ahead of any regulatory changes. We achieve this by utilising various Regulatory Intelligence tools, Artificial Intelligence, completing monthly manual reviews of authority websites, as well as having a vast network of local knowledge to collect and evaluate local and global regulations.

The thorough analysis of any findings from each of these sources allows for an up-to-date Regulatory Intelligence Repository that colleagues can access to easily answer queries either internally or from clients. Where the answer isn’t already available, ProPharma has the ability to provide fast turnaround responses to ad-hoc requests for Regulatory Intelligence, going as far as offering one- to- one Regulatory Intelligence consultations.

Having access to the most up-to-date global regulation requirements, and the knowledge to interpret these regulations accurately, makes ProPharma completely qualified to perform submissions all over the world. This applies to periodic and expedited submissions, as well as Post-Marketing and Clinical Aggregate Report submissions, and EU product registration and updates in XEVMPD.

Our top priority at ProPharma is regulatory compliance, ensuring that all submissions are performed in accordance with applicable regulations. Due to our Regulatory Intelligence repository and expert interpretations of requirements, ProPharma is proud to consistently post a greater than 99% compliance rate for regulatory submissions, successfully submitting over 2,000 ICSRs per month to health authorities and ethics committees, and distributing reports on-time to investigators and business partners on behalf of our clients.

For clients utilizing our PV submission services, we offer access to the relevant RI for no additional cost, and for clients not utilizing our submissions services, we offer subscriptions to our PV RI information and updates. This information is provided in three different options that build upon each other, allowing the use of a single format or combination of formats. When you have needs, we have answers. Let us know how we can support you today.