We deliver tailored, data-driven strategies that turn complex challenges into measurable growth—so you can focus on what matters most: scaling your impact.
Unlock Your Next Level
Intelli Science Consulting Group delivers specialized consulting at the intersection of regulatory science, pharmacovigilance, advanced analytics, and data-driven innovation — empowering life sciences organizations to operate with confidence and precision.
Our Services
End-to-End Consulting Solutions
From regulatory strategy and safety operations to predictive analytics and technology implementation, Intelli Science provides integrated solutions across the full drug development and commercialization lifecycle.
Deep Expertise
Specialized Capabilities Across the Value Chain
Our multidisciplinary team brings domain-specific depth to every engagement, ensuring solutions are grounded in scientific rigor and operational realism.
Regulatory & Safety — Global Compliance & Risk Management
End-to-end regulatory intelligence and pharmacovigilance operations, from submission strategy through post-market surveillance and inspection response. Regulatory intelligence monitoring and impact assessment. Risk Management Plan development and evaluation. REMS design, implementation, and reporting. Inspection readiness across GCP, GLP, and pharmacovigilance.
Clinical Operations — Trials & Safety Monitoring
Operational support for clinical safety activities, from site-level oversight through individual case processing. Ethics submissions, audits, training, and PV quality systems.
Advanced Analytics — AI, ML & Statistical Modeling
Data-driven decision support leveraging artificial intelligence, machine learning, and advanced statistical methods across the product lifecycle. Predictive safety analytics, automated signal detection, NLP for regulatory documentation, and benefit-risk modeling.
Patient & Commercial — Services Optimization & Analytics
Strategic and analytical support for patient-facing programs and commercial operations, bridging regulatory requirements with real-world access and adherence.
Bioinformatics & Omics — Genomics, Proteomics & More
Computational biology and multi-omics integration to support translational research, precision medicine, and regulatory submissions involving complex biological data.
From first regulatory filing through post-market lifecycle management, we embed within your operations to execute with precision and accountability. This section tells the visitor: "Here is exactly what we deliver."
Regulatory Affairs & Compliance
Strategic regulatory intelligence, PSUR preparation, RMP development, REMS design, and full lifecycle management. Inspection readiness for FDA, EMA, and global health authorities. PBRER/PSUR/PADER/ASR. RMP/REMS. Inspection readiness GCP/GVP.
Pharmacovigilance & Drug Safety
Comprehensive ICSR assessment, signal detection, aggregate safety reporting, and quality systems development. CAPA programs, vendor oversight, and audit support for global PV operations.
Clinical Research & Trial Management
Safety monitoring across therapeutic areas, GCP compliance, trial master source management, and investigator site support. Study-level safety reporting and pharmacovigilance agreements.
Data Analytics & Business Intelligence
Advanced statistical modeling, machine learning, KPI development, and automated dashboards. Real-world data analysis, comparative effectiveness research, and AI-powered insights for strategic decisions.
Patient Services & Commercial Analytics
Patient journey mapping, flow forecasting, hub services analytics, and adherence program evaluation. AI-driven Next Best Action recommendations and launch readiness analytics for commercial teams.
Data Infrastructure & Governance
Patient data warehouse design, PII/PHI/OIG compliance frameworks, master data management, and CRM optimization. Automated data quality validation, multi-source data aggregation, and Snowflake deployments.
Let's Work Together
Ready to accelerate your growth? Schedule a complimentary consultation to explore how our solutions can fit your objectives and budget. We’ll outline next steps and ensure you have all the information needed to make an informed decision.
Who We Are
Our company was founded over thirty years ago in Spain, where a small team of professionals set out to solve a straightforward problem: the growing gap between what regulators required and what companies could operationally deliver.
Through the 1990s and into the 2000s, as European pharmaceutical regulation matured and international harmonization accelerated, the firm grew alongside its clients — building methodologies, refining processes, and earning a reputation for work that was both scientifically defensible and practically executable.
Expansion to Canada marked a pivotal chapter, adding North American regulatory depth and positioning the team to serve clients operating across multiple jurisdictions simultaneously. Working at the intersection of Health Canada, FDA, and EMA requirements sharpened a core competency that remains central to our identity: the ability to translate between regulatory systems rather than simply replicate compliance checklists.
In 2025, we established our headquarters in the United States as Intelli Science Consulting Group.
The new name carries forward three decades of institutional knowledge while signaling the next chapter — one defined by advanced analytics, AI-driven safety science, and an expanded global consulting practice. Our trajectory — from a European founding through North American expansion to a US-based firm serving clients worldwide — mirrors the increasingly borderless nature of the industry we serve.
Regulatory Updates:
2026-01-14: EMA: EMA and FDA set common principles for AI in medicine development
https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-development-0
2026-05-06: USA: News Release FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight
2026-04-24: Jordan: Guideline on Good Pharmacovigilance Practice (GVP) IN Jordan (for pharmaceutical products): public consultation
2026-04-15: EMA: EMA recommends authorisation of first veterinary vaccine using RNA technology
2026-04-01: Singapore: Guidance for industry post-marketing vigilance requirements for therapeutic products and cell, tissue and gene therapy products
2026-03-28: Brazil: Anvisa published normative instruction (IN 289/2024) and guidelines on Regulatory Reliance Rules optimize the approval of drug products, biological products, and vaccines