AI-Empowered Regulatory Services

Based in the Netherlands, Maurice has over 27 years’ experience in the pharmaceutical and biotech industry, mainly supporting pre-approval drugs and biologics for oncology, pulmonary and cardiovascular indications, with extensive experience in developing regulatory strategies, leading cross-functional teams in health authority interactions (Scientific Advice, both on national and EU level) regulatory intelligence and applications including document development to support applications such as MAAs, CTAs, EU & US Orphan Drug Applications, PIPs, iPSPs, IND Annual Reports and DSURs.  He holds a Master’s degree in Medical Biology from the University of Utrecht and a Doctorate in Medicines from the University of Leiden, Netherlands.  Fastest EU MAA approval for a monoclonal antibody in an ultra-orphan (at the time). Successfully guided a client through the PIP application process in 9 months (average is 18). 

He holds a Master’s degree in Medical Biology from the University of Utrecht and a Doctorate in Medicines from the University of Leiden, Netherlands.

Fastest EU MAA approval for a monoclonal antibody in an ultra-orphan (at the time). Successfully guided a client through the PIP application process in 9 months (average is 18).

With 20+ years of Pharmaceutical industry experience across Drug Discovery, Regulatory Affairs, and Compliance, Pradeep is a system and business process owner leading our Pharma division delivery teams. Pradeep holds a Master's degree in Biotechnology from Bangalore University.

• Established a Regulatory Operations team for Consumer Health business unit
• Spearheaded several RIM/eDMS and publishing system migrations
• Successfully managed xEVMPD integration into P&G Healthcare business unit
• Led business process harmonization and digitization activities for raw materials documentation and its compliance
• Co-chaired IDMP office

Maikel Bouman is our Associate Director of Regulatory Operations and Publishing, with 8 years of industry experience.

He has broad subject matter expertise on the quality control of data, document publishing, planning/coordination, management, preparation/creation, and dispatch of different types of electronic submission formats to various regulatory authorities across the Americas, Europe and Australia.

As a manager within Regulatory Data Management at Celegence, John has extensive experience in xEVMPD, IDMP, RIMS, and Regulatory Affairs.

John has supported numerous pharmaceutical companies in their digital transformations by selecting the right regulatory information management system, extracting & remediating regulatory data, reviewing and updating underlying processes, and fostering a culture of collaboration and innovation among teams to drive successful change.