We are GMP & regulatory compliance specialists helping therapeutic goods manufacturers, testing laboratories

and biotechnology companies

IF A REGULATOR WALKED IN TODAY,

ARE YOU PREPARED FOR AN AUDIT?

At Quality Systems Now, we understand the pressure of being audit-ready. That’s why our Compliance Readiness Assessment is designed to help you quickly identify any gaps in your GMP and ISO 13485 compliance.

WHAT WE DO

We are GMP consultants, specializing in helping pharmaceutical and medical device manufacturers, testing laboratories and associated supporting companies gain or maintain their GMP manufacturing license or ISO accreditation, and everything in-between!

Check out out services - we can help you with:

  • General GMP

  • Quality Management Systems (QMS) / Pharmaceutical Quality Systems (PQS)

  • Validation

  • Laboratory systems, equipment, methods, specifications etc.

  • Product development guidance

  • Quality Assurance

  • Training

  • Audit readiness

  • Third party or internal audits

  • Electronic system implementation

  • Regulatory compliance

  • Production & facilities

  • Compliance to Good Distribution Practices (GDP) and supply chain.

WHY WORK WITH US

We often have clients who return to QSN multiple times because of the great experience they have working with us.

QSN consultants are knowledgeable in their niche areas of expertise. They have been in the industry for many years, working with clients, so they have authority and know what works in practice.

We also pride ourselves on being flexible and agile, able to quickly engage and assist clients, wherever they are on their compliance journey.

And we won't over-complicate things, we keep it simple!

Why Work with Quality Systems Now

We support clients across four core service areas:

Site Licensing and Accreditation
QMS
Auditing and Regulatory Compliance
Biz Transformation and Regulatory Compliance
Training

OUR FRAMEWORK

We work with all clients using our QSN framework. Whether you need help with all stages or just one or two to meet your goals, this is our roadmap for delivering your project.

Check out our QSN framework below.

QSN Framework

SIX PILLARS OF IMPLEMENTATION

As part of the framework Stage 3 - Begin the Transformation, QSN uses the following compliance pillars to help you implement your project.

So, whether you have a new greenfield site, or a documentation project, we understand the wider view and can help you deliver a simple, compliance solution.

Six Pillars of Implementation for Quality Systems Now

SOME OF THE INDUSTRIES WE SUPPORT

PHARMACEUTICAL

MEDICAL DEVICES

BIOTECH

TRANSFORM YOUR PROCEDURES INTO

USER-FRIENDLY DOCUMENTS USING PLAIN LANGUAGE

Learn how to eliminate:

  • Mix-ups, mistakes, high error rates or impacts from unclear, incomplete or incorrect documents

  • Inefficiency and decreased productivity

  • Negative impacts during development or manufacturing

  • Inspection deficiencies that impact time, cost and company reputation.