BioGreen supports pharmaceutical manufacturers across Australia, New Zealand, and the broader Asia Pacific region in adhering to regulatory requirements set by TGA, MedSafe, PIC/S, EU, and US FDA GMP standards. Our multidisciplinary team of consultants, architects, engineers, and scientists boasts diverse skills and experiences, ensuring tailored expertise for your project at any stage.

For resource-constrained organizations seeking seasoned GMP contractors to execute projects efficiently, BioGreen provides a pool of professionals equipped with a wide array of GMP skills and knowledge.

We offer project management services to facilitate seamless production startups and ensure compliance with industry regulations.

We guide you in identifying the relevant regulations and achieving compliance without compromising business success.

Boasting consultants with years of TGA and PIC/S auditing experience, BioGreen conducts audits grounded in profound understanding of international pharmaceutical manufacturing regulations.

Pre-lease and pre-construction, we conduct independent GMP reviews of your facility design to ensure no detail is overlooked.

Receiving an audit deficiency notice can be daunting. BioGreen assists in preparing effective audit responses, whether it entails major remediation or addressing minor issues.

Our comprehensive validation services cover cleaning, process, and computer system validations.

Complying with PIC/S GMP and FDA requirements, we conduct product quality reviews through our GMP vendor management audit program.

We facilitate the identification and qualification of overseas manufacturers and suppliers.

We devise registration strategies and submissions for companies aiming to enter the Australian drug market.

BioGreen offers a suite of services and products tailored to ensure QMS compliance for pharmaceutical manufacturers.

We educate on implementing Lean Manufacturing and Six Sigma methodologies within the pharmaceutical industry’s regulatory framework.

We assist in recruiting permanent or temporary staff with specific GMP technical skills and experience.

BioGreen offers a diverse range of online and in-person training courses covering Validation, GLP, GDP, and GMP.

To learn more, request a quote, or ask questions, please complete our enquiry form here.