EU MDR Compliant Templates for a Multinational Pharmaceutical Company
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence.
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Life sciences companies have to proactively monitor regulatory changes to ensure compliance, maintain market access, and optimize submission strategies. Celegence provides comprehensive regulatory intelligence consulting, helping pharmaceutical and biotech companies navigate geography-specific requirements, product lifecycle management, and global compliance trends.
Our global teams leverage a network of regional specialists to deliver real-time insights, impact analysis, and competitive intelligence, enabling organizations to anticipate regulatory shifts, standardize processes, and accelerate approvals.
| Regulatory Requirements Intelligence | Monitoring and reporting on clinical trial submissions, marketing authorizations, and post-marketing regulations across global markets. |
| Impact Analysis Reports | Evaluating the business impact of changing regulations on existing and future product portfolios. |
| Orphan Drug Designation (ODD) & Pediatric Investigation Plans (PIPs) | Preparation, submission, and maintenance of ODD and PIP applications, including transfers. |
| Global & Local Regulatory Submission Consulting | Supporting companies in defining, monitoring, and executing their regulatory submission plans across multiple jurisdictions. |
| Regulatory Trends & Operational Insights | Delivering trend reports on regulatory operations, interpretation of guidelines, and best practices to improve KPIs and compliance strategies. |
| Regulatory Submission Strategy | Providing strategic intelligence based on internal data, therapeutic areas, and evolving regulations to optimize submissions. |
| Competitive Gap Analysis & Benchmarking | Offering competitive regulatory insights to benchmark submission timelines, dossier requirements, and approval strategies. |
| Soft Intelligence & Centralized Storage | Maintaining a central repository of internal and external regulatory intelligence for easy access to evolving requirements and historical insights. |
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Principal SME, Pharmaceutical 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.
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Head of Regulatory Affairs
Marloes provides regulatory affairs consultancy and services to both big- and small-sized pharmaceutical companies, covering a wide variety of products.
Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Awarded DIA Leader of Tomorrow in 2016. Helped author the biosimilar guidelines across the globe.
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Regulatory Affairs SME
Diede is a Regulatory Affairs Subject Matter Expert. She specializes in clinical trial applications and scientific advice, with a primary focus on regulatory processes within Europe, including European Medicines Agency (EMA) and Clinical Trials Information System (CTIS). With experience in Regulatory Intelligence, eCTD template development, and Module 1 documentation support – including electronic Application Forms (eAF), Product Information, and Risk Management Plan (RMP) updates – Diede brings a thorough understanding of regulatory strategies to her role. She holds a PhD in Hemato-pathology and both a Bachelor’s and Master’s degree in Biomedical Sciences. Her academic expertise, combined with her industry experience, enables her to navigate regulatory landscapes and provide guidance to clients.
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Our proprietary cloud-based dossier management solution eliminates manual steps in the exchange of regulatory dossiers. It allows you to share, view, and review eCTD, NeeS, and other dossier formats from any region and access them in any location.
The hybrid solution offers you cloud-based software as a service whilst keeping your data privately stored on-site or in a virtual private cloud.
Dosscriber™ helps stand-alone regulatory documents for, amongst others, NDA/BLA, IND, NDS, MAA, CTA, PIP, scientific advice, and briefing packages.
With consistent document structure, naming, and eCTD-readiness, Dosscriber™ templates facilitate repurposing documents across countries, products, and dossier types – without rework.
Anticipate and adapt to regulatory changes before they impact your submissions and approvals.
Ensure a 50% reduction in regulatory assessment time, leading to quicker approvals.
Leverage competitive benchmarking, impact assessments, and submission tracking for informed regulatory actions.
Our regional regulatory specialists provide geo-specific intelligence to streamline compliance strategies.
From pre-market strategy to post-market compliance, we offer continuous regulatory monitoring and insights.
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From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence.
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