The Dutch life sciences ecosystem is experiencing rapid growth across R&D, commercialization, and industrialization, bringing new challenges in regulatory affairs, quality management, clinical operations, pharmacovigilance, and manufacturing excellence. From EMA submissions and MDR transitions to GMP validation and ISO 13485 frameworks, the volume and complexity of workstreams demand specialized expertise and robust project leadership. SIRE Life Sciences Netherlands provides an integrated consultancy and interim management model designed for this reality—deploying seasoned consultants and project managers who combine hands-on operational experience with deep knowledge of EMA, GMP, ISO, MDR, and pharmacovigilance best practices.
Headquartered in Haarlem, SIRE Life Sciences serves clients across Amsterdam, Leiden, Utrecht, Rotterdam, and Eindhoven with a flexible, outcomes-based approach. Organizations can engage interim consultants for targeted interventions or deploy complete project teams to lead cross-functional initiatives from planning through execution and inspection readiness. The model is built to deliver immediate impact, whether the need is to clear a CAPA backlog, prepare for an authority inspection, scale a new production line, or stand up a clinical operations program.
SIRE Life Sciences’ consultancy and project management portfolio covers the full spectrum of the needs of the Dutch life sciences. In regulatory affairs, interim experts support EMA submissions, CMC strategy and documentation, and end-to-end regulatory pathway planning. In quality and GMP, project managers lead audits, validation, equipment qualification, cleaning and process validation, data integrity initiatives, CAPA remediation, and inspection readiness activities. Clinical operations specialists provide trial management, CRO/vendor oversight, monitoring strategies, site activation and training, and TMF quality programs.
Pharmacovigilance professionals support safety system implementations, risk management plans, PSURs, and signal detection governance. Engineering and manufacturing project managers drive scale-up, tech transfer, lean implementation, OEE improvements, serialization and traceability initiatives, and supply chain optimization. In medical devices, consultants guide ISO 13485 QMS maturation, CE marking, technical documentation, clinical evaluation, and PMS/PMCF requirements under MDR. For the food & nutrition sector, interim experts help with labeling compliance, HACCP, quality by design, innovation governance, and risk management.
SIRE Life Sciences assembles project managers, PMO specialists, and subject-matter experts who can run stage-gate, agile, or hybrid delivery models adapted to GxP environments. The teams prioritize risk-based planning, issue escalation, stakeholder alignment, and transparent reporting to keep complex programs moving. With a deep bench of consultants validated for Dutch and EU regulatory contexts, companies gain a single partner that can advise and execute—reducing handoffs, compressing timelines, and improving right-first-time outcomes.
Recognizing the transformative role of data and automation, SIRE Life Sciences also integrates AI-enabled project management practices where appropriate, focusing on validated, compliant use cases. Teams can augment workflows with generative AI capabilities, such as ChatGPT-style copilots, to assist with drafting SOPs, summarizing evolving regulatory guidance, accelerating document QC, or supporting pharmacovigilance literature screening and signal triage.
These tools are applied under strict governance for confidentiality, data integrity, and compliance, and are paired with human oversight. For organizations preparing for the EU AI Act and related guidance, SIRE Life Sciences provides readiness assessments and practical controls to ensure the responsible adoption of AI in regulated environments.
SIRE Life Sciences’ Dutch market presence is backed by one of Europe’s largest and most engaged life sciences talent networks, connecting clients to 375,000+ professionals and a proven track record of 4,000+ successful placements. This scale translates into rapidly deploying interim specialists and project teams ready to contribute from day one. The company’s results-driven model and collaborative style have earned recognition across the industry, including FD Gazellen honors, multiple GHP International Life Sciences and Private Healthcare awards, Supplier Excellence Awards (including 2024), and inclusion in the FT 1000 ranking of Europe’s Fastest Growing Companies.
Clients engage SIRE Life Sciences for programs that matter: regulatory submissions that unlock market access, quality remediation that strengthens license security, clinical operations that maintain trial integrity and speed, device MDR transitions that sustain EU distribution, and manufacturing scale-ups that support supply reliability and cost efficiency. The consultancy’s client portfolio includes collaborations with leading organizations such as Janssen, Teva Pharmaceuticals, Pfizer, Amgen, Sanofi, and Philips Healthcare, among others, across pharma, biotech, medtech, chemicals, and food sectors.
For companies seeking flexible engagement models, SIRE Life Sciences offers secondment, direct hire, temporary-to-hire, temporary staffing, brokering, and Statement of Work structures. This versatility ensures that strategy, execution, and resourcing align with business needs and budget realities.
SIRE Life Sciences’ mission in the Netherlands is clear: empower life sciences innovators to move faster, remain compliant, and scale sustainably. The consultancy’s work bridges advisory and delivery, translating regulatory and quality requirements into executable project plans with measurable outcomes. In a market where the cost of delay is high and the regulatory bar continues to rise, this end-to-end capability provides a decisive advantage.