Your Trusted Partner For Success In Regulatory and Quality Operations, and Supporting Systems

Submission Timeline Dragging You Down?

We help you meet critical deadlines with
precision and speed:

  • Decades of regulatory expertise across
    diverse therapeutic areas
  • Full IND submissions delivered in 2 weeks
  • Over 25 successful marketing applications
    submitted

Struggling to Implement Systems and Processes?

Let us take the lead on your digital
transformation:

  • Strategic guidance across 40+ system
    implementation projects
  • Certified Veeva partner with deep
    platform expertise
  • Proven experience with 10+ regulatory and
    quality systems

Compliance Keeping You Up at Night?

Stay inspection-ready and industry-aligned
with our support:

  • Hands-on assistance during regulatory
    inspections
  • Actively engaged in industry
    communities and forums

Our Services

Our Expertise. Your Advantage.

Document Formatting & Publishing

We provide expert document formatting and publishing services to ensure regulatory compliance, clarity, and submission readiness for health authority approvals.

Submission Publishing & Management

We specialize in submission publishing and management, ensuring accurate compilation, formatting, and dispatch to health authorities with ongoing support for a seamless approval process.

Regulatory Archive Management

We provide secure and compliant archiving support for regulatory documents, submissions, and correspondence, ensuring easy retrieval, data protection, and streamlined future submissions.

RIM System Implementation, Support & Management

We specialize in Regulatory Information Management (RIM) and Quality systems, particularly Veeva, helping clients implement tailored solutions that enhance compliance, data integrity, and regulatory efficiency.

Quality System Implementation, Support & Management

We provide continuous RIM and Quality system 
support, ensuring compliance, optimal performance, 
and proactive issue resolution through regular audits, maintenance, and process improvements.

Business Process Improvements

We create and evaluate SOPs and work instructions to ensure clarity, compliance, and best practices, with regular updates to align with regulatory changes and operational needs.

Contact Us

Interested in working together? Fill out some info and we will be in touch shortly. We can’t wait to hear from you!

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