OUR CREDO

Building Excellence in Life Sciences Documentation & Training

OUR VISION

We envision a world with robust end-to-end solutions that remove the constraints of inefficient business practices, uncertain procedures, outdated technologies and disorganized systems that impede life sciences innovation and regulatory compliance.

OUR MISSION

Our mission is to enable great scientific minds in life sciences, allowing them to focus on driving breakthrough discoveries forward, with methodical solutions that incorporate meaningful automation and enable enhanced teamwork across the entire regulatory, quality, and research ecosystem.

OUR PHILOSOPHY

Since 1973, JANA's philosophy has remained constant: addressing our customers' immediate needs while fostering their long-term growth through highly customizable and flexible services. As JANA Life Sciences, we carry forward this heritage with laser focus on the unique complexities of life sciences documentation and regulatory requirements.

"The JANA Way" - Always looking beyond quick fixes has cultivated enduring partnerships with some of the world's largest life sciences companies. Our methodical approach to excellence distinguishes us in an industry where compliance failures can halt operations and documentation errors can trigger regulatory action.

We believe that building and ensuring excellence in life sciences documentation accelerates time-to-market while ensuring regulatory compliance - enabling innovation that ultimately serves healthcare providers and patients worldwide.

OUR FOUNDATION: FOUR PILLARS OF EXCELLENCE

OPERATIONAL EXCELLENCE

Optimize your business by embracing methodical process management

  • Quality Management System (QMS) development and ISO 13485:2016 compliance

  • CAPA planning, root cause analysis, and FDA 483 response protocols

  • Training programs and Training Within Industry (TWI) methodology implementation

  • Systematic approaches that ensure audit readiness and regulatory integrity

DATA & DOCUMENTATION

Transform highly complex life sciences information into clear, compliant content

  • Technical documentation for FDA submissions and regulatory pathways

  • 3D modeling and visualization for medical device development

  • LIMS validation protocols (IQ, OQ, PQ) and 21 CFR Part 11 compliance

  • Structured content development using XML, S1000D, and DITA standards

IT SYSTEMS

Organize your IT systems to maximize productivity and ensure compliance

  • Software validation and electronic records management

  • Cloud-based solutions for regulated environments

  • Database design and system integration for life sciences workflows

  • Full-stack development supporting regulatory documentation systems

PROJECT & PROGRAM MANAGEMENT

Move your program into action with confidence around regulatory objectives

  • End-to-end project lifecycle management for FDA submissions

  • Cross-functional team leadership across regulatory, quality, and R&D

  • Risk assessment and mitigation planning for compliance-critical projects

  • Vendor coordination ensuring seamless integration with existing systems

OUR TEAM

The heart of JANA Life Sciences is our people - technical experts who understand both engineering precision and regulatory requirements. We foster a culture where 50+ years of proven technical excellence meets cutting-edge life sciences innovation.

Our family-owned heritage provides stability and long-term thinking in an industry that demands both rapid innovation and methodical compliance. Every team member contributes to our ISO 9001:2015 and ISO 13485:2016 certified quality management system, ensuring that methodical excellence guides every project delivery.

We invest in continuous learning because life sciences regulations evolve constantly. Our team's deep understanding of FDA requirements, GxP protocols, and international compliance standards enables us to serve as trusted advisors, not just service providers.

OUR PARTNERS

In life sciences, no organization succeeds alone. We cultivate strategic partnerships that extend our capabilities while maintaining our methodical standards:

Technology Partners like Data Conversion Laboratory and Court Square Group enhance our data management and cloud solutions capabilities.

Regulatory Specialists who complement our technical documentation with deep compliance expertise.

Industry Alliances through professional associations (RSNA, ASTRO, ISPE) that keep us current with evolving standards and emerging technologies.

We view partnerships as extensions of our family, supporting mutual success while never compromising the methodical excellence that defines "The JANA Way." Together, we accelerate life sciences innovation through superior documentation and validation services.

OUR VALUES & COMMITMENT

To Life Sciences Innovation

We recognize our responsibility to support breakthrough discoveries that improve human health. Every documentation project, every validation protocol, every training program we deliver contributes to bringing life-saving innovations to market faster and safer.

To Building Excellence

We embody honesty, integrity, transparency, and accountability in every interaction. Our ISO-certified processes ensure consistent quality delivery, while our 50+ years of experience provides the wisdom to adapt methodically to new challenges.

To Regulatory Integrity

In an industry where documentation errors can delay FDA approvals or trigger compliance actions, we maintain unwavering commitment to accuracy, traceability, and audit readiness. Our methodical approach protects our clients' regulatory standing while accelerating their innovation timelines.

To Sustainable Growth

We balance immediate project needs with long-term strategic value, helping life sciences companies build scalable documentation infrastructures that grow with their innovation pipeline. Our family-owned perspective enables patient capital allocation and relationship-focused decision making.

OUR PROMISE

Beyond Software - Expert Human Partnership

While others focus on technology platforms, we provide the human expertise that understands your science, your regulatory challenges, and your business objectives. Our focus on building excellence in life sciences documentation and training ensures that innovation proceeds with confidence, compliance, and speed.

This is The JANA Life Sciences Way - methodical solutions that enable great scientific minds to change the world.