DEVELOPMENT COMPLIANCE

FOR R&D TEAMS

Helping R&D Teams Transition to Towards Commercialization with Confidence

Emerging R&D companies often struggle to balance innovation with increasing compliance rigor. Laboratory methods, lab-scale batches and informal practices that worked for early development often do not transition well through to clinical and GMP/ ISO13485.


Without a phase-appropriate Quality Management System (QMS) – GLP, GCP, GMP - the risk is high—overbuilding systems too early or underpreparing for manufacturing, validation, and licensing requirements.

 

At Quality Systems Now (QSN), we help you bridge that gap — turning scientific success into regulatory success.


We guide you to establish strong compliance practices and rigor appropriate for each stage of product development using our proven QSN R&D Framework and the Six Pillars of Implementation for R&D.

The Challenges We Solve

  • Inadequate phase-appropriate compliance – Early-stage systems don’t scale for GxP expectations.

  • Limited understanding of GxP and sponsor responsibilities – Even when testing or manufacture is outsourced, the sponsor remains accountable.

  • Unverified processes and data integrity risks – Informal methods and incomplete validation threaten product quality and submission timelines.

  • Disconnected operations – Data, documentation, and process control systems evolve separately, creating inefficiencies and compliance gaps.

Our Framework: From Idea to Inspection-Ready

QSN applies a structured, end-to-end approach to every engagement.
Our R&D Framework ensures your quality, compliance, and operational systems work together to achieve your commercialization goals.

The Six Pillars of Implementation

Our Six Pillars Framework ensures all parts of your compliance ecosystem work together to deliver robust, scalable, and auditable systems.

Ready to Commercialize with Confidence?

Whether you’re scaling for clinical manufacture, preparing for GMP licensing, or transitioning to ISO 13485 accreditation — QSN helps you connect the dots between R&D, quality, and business performance. Book a Discovery Call to assess your readiness and receive a tailored commercialization roadmap.