Establised
01/01/2021
Company Overview

Critical Compliance staff have worked in the therapeutic goods manufacturing industry for over 10 years, covering both medical devices and pharmaceuticals. Offering quality and regulatory consulting services to organisations of all sizes within manufacturing and distribution, Critical Compliance assists companies achieve compliance goals, with a focus on helping companies reach and maintain the highest standards of product quality and safety.

KEY CAPABILITIES

Capability areas: Consulting: quality and regulatory
Auditing: Internal, Supplier, General
Validation: radiation sterilisation, general, reusable medical device, ethylene oxide sterilisation
ISO13485 & PIC/S GMP, sterile and non-sterile Medical Devices and Medicines Listed/Registered

DIFFERENTIATORS

CORE PRODUCTS/SERVICES

Therapeutic Goods Consultant: Critical Compliance offers generalist therapeutic goods advice, with significant experience in quality systems, quality assurance, regulatory affairs, manufacturing and validation of medical devices and pharmaceuticals. It has helped set up and grow a number of organisations within the therapeutic goods space and can assist companies with initial product development and manufacturing facility design, through to conformity assessment, licensing and applications.

SIZE BY EMPLOYEES

1

MEDTECH INDUSTRY SELF-CLASSIFICATION

Support (consulting, quality assurance, regulatory etc)

CERTIFICATIONS/ACCREDITATIONS

Bachelor of Biotechnology, Master of WH&S, Master of Public Health, Diploma of Quality Auditing

MARKETS

Australia-wide

KEY CUSTOMERS

Manufacturers and suppliers of therapeutic goods

UNIVERSITY COLLABORATIONS

Over the years Critical Compliance staff has supervised numerous placement students from the UoN Biotechnology degree program, volunteered in industry advisory committees for Biotechnology and Medical Engineering, and mentored students through the iLEAD program.

MANUFACTURING CAPABILITY