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Instem

SaaS platforms for pharmaceutical R&D and regulatory compliance

United Kingdom
Est. 1969
500+ employees
Verified
57+ Yrs
1 Cert

About Instem

Instem is a life sciences software provider established in 1969, specializing in SaaS platforms for drug and therapy development. The company serves over 700 clients worldwide across pharmaceutical, biotechnology, CRO, CDMO, academic research, industrial, and agrichemical sectors. Instem operates globally with presence across North America, EMEA, and APAC regions.

The company's portfolio spans four main solution areas: In Silico & Data Insights for predictive analytics and toxicology modeling, Study Management for preclinical research data collection and analysis, Regulatory Submission tools for FDA and global regulatory compliance, and Clinical Trial Analytics for accelerating clinical development timelines. Notable products include Provantis, Pristima, Climb for study management, and SEND Advantage Services for regulatory data conversion.

With over 50 years of experience supporting complex research projects, Instem positions itself as a comprehensive platform provider for the drug development lifecycle, from early discovery through regulatory approval. The company maintains localized support teams across its global footprint to serve its international client base.

Best For

Pharmaceutical companies, contract research organizations, and biotechnology firms requiring comprehensive software infrastructure for preclinical and clinical research operations. Organizations needing regulatory submission expertise, particularly for FDA SEND data requirements, and those seeking to integrate multiple research systems across the drug development lifecycle.

Key Strengths

  • 55+ years of specialized experience in life sciences research software with deep regulatory knowledge
  • Comprehensive platform coverage spanning discovery, preclinical, clinical, and regulatory submission phases
  • Global support infrastructure with localized presence in North America, EMEA, and APAC regions
  • Established client base of 700+ organizations including major pharmaceutical and CRO companies
  • Specialized SEND regulatory submission services addressing critical FDA compliance requirements
  • Extensive product portfolio with 20+ specialized applications for different research workflows

Why Choose Instem

Choose Instem when you need a long-established vendor with deep pharmaceutical research expertise and proven regulatory compliance capabilities. The company excels in supporting organizations requiring end-to-end platforms for preclinical studies, toxicology assessments, and regulatory submissions to global health authorities.

Expect a comprehensive but complex implementation process with access to specialized domain expertise in areas like SEND data standards, in silico toxicology, and GLP-compliant study management. Best suited for organizations prepared to invest in enterprise-level software infrastructure with long-term vendor relationships.

Healthcare Focus

Instem exclusively serves the life sciences sector, focusing on pharmaceutical companies, biotechnology firms, contract research organizations, and academic research institutions involved in drug discovery and development. The company's healthcare impact is indirect, providing the software infrastructure that enables safer, more effective pharmaceutical products to reach patients.

Key healthcare-related capabilities include toxicology prediction for drug safety assessment, preclinical study management for GLP compliance, clinical trial analytics for accelerating therapy development, and regulatory submission tools ensuring data meets FDA, EMA, and other global health authority requirements. The company supports research across multiple therapeutic areas including oncology, rare diseases, and medical devices.

Ideal Client Profile

Mid-to-large pharmaceutical companies, established biotechnology firms, and contract research organizations conducting preclinical and clinical studies requiring regulatory submission support. Organizations with complex research workflows needing integrated data management across multiple study types, particularly those facing FDA SEND requirements or seeking to modernize legacy research systems with cloud-based alternatives.

Specializations

Preclinical study management In silico toxicology modeling Regulatory submission preparation Clinical trial analytics SEND data conversion services Laboratory information management systems Predictive safety analytics

Client Types

Pharma Medical Devices Healthcare Startups Digital Health

Why Choose Instem?

  • 57+ years of industry experience
  • 500+ team members
  • 1 certification verified
  • Select Partner on Curatrix
  • Verified on Curatrix

Quick Facts

Headquarters
United Kingdom
Founded
1969
Company Size
500+ employees

Certifications

iso 9001

Profile last updated: Jan 26, 2026

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