INITS expands internationally and joins the CCRM Australia Partner Network to Advance Global Biotech Innovation

• A strategic gateway between Europe and Australia: INITS will support Australian biotech companies in navigating European clinical and regulatory pathways.

• Expanded global network and collaboration: By joining over 50 partners in the CCRM Australia network, INITS connects with global leaders in regenerative medicine.

• A shared mission to accelerate advanced therapies: INITS and CCRM Australia aim to bridge innovation in cell and gene therapy (C&GT) across continents.

A strategic collaboration bridging CMC and regulatory expertise between Europe and Australia

INITS, a Montpellier-based consulting and bioproduction services company specializing in biological drug development, is proud to announce its official partnership with CCRM Australia, a leading organization dedicated to accelerating the commercialization of regenerative medicine and cell and gene therapies.

As a new member of the CCRM Australia Partner Network, INITS brings deep expertise in pharmaceutical development, clinical trial setup, and regulatory compliance across Europe. This partnership aims to support Australian biotech companies seeking to access the European market while also enabling INITS to strengthen its international presence through CCRM Australia’s dynamic ecosystem of academic and industrial collaborators.

“Joining the CCRM Australia Partner Network is a strategic milestone for INITS,” said Amel Hadri, CEO of INITS. “We are thrilled to work alongside such a dynamic organization and to support Australian biotech companies on their clinical, regulatory, and CMC journeys in Europe. This partnership reinforces our shared commitment to accelerating access to life-changing therapies worldwide”.

CCRM Australia is part of the Global CCRM Network, inspired by the successful CCRM model, which has been extended to several international hubs, including Sweden (CCRM Nordics), with additional hubs planned for the future. The network focuses on fostering collaboration among research institutions, industry, and government to bring advanced therapies from the bench to the bedside.

“We are delighted to welcome INITS into the CCRM Australia Partner Network,” said Silvio Tiziani, CEO of CCRM Australia. “Their expertise in European clinical development and regulatory affairs is a valuable asset to our network. Together, we can build stronger bridges between continents to accelerate the global regenerative medicine sector.”

As part of the partnership, INITS will engage in collaborative R&D opportunities, contribute to customized educational programs, and participate in industry events and initiatives designed to enhance the visibility and impact of emerging biotech innovations.

About INITS

Founded in 2013 and headquartered in Montpellier, France, INITS is a dynamic consulting firm supporting biotech companies throughout their pharmaceutical development journey.

INITS has over 12 years of experience and has supported more than 250 clients in France and internationally.

With a strong expertise in biologics (C&GT, EVs, mAbs, proteins) and a team of more than 30 passionate experts, INITS covers all pharmaceutical development challenges, including services in CMC, Regulatory, Clinical Supply, Quality Assurance, and Audits.

For several years, INITS has been developing an innovative project: INITS SMO, a shared bioproduction unit that is expected to be operational in Q2 2026. This unit will allow biotech companies to maintain control over their process while benefiting from INITS’ support (Regulatory, QA, QC, analytical, supply, etc.).

About CCRM Australia

CCRM Australia is the Australian Hub of the highly successful Centre for Commercialization of Regenerative Medicine (CCRM) Global Network. Established as a not-for-profit with a national focus, CCRM Australia’s mission is to address bottlenecks in the translation and commercialisation of regenerative medicine discoveries in Australia, many of which have the potential to cure some of the most devastating and costly diseases in the world today.

CCRM Australia’s commercially focused solutions enable businesses and research partners to achieve their commercialisation objectives by providing customised country, market and industry-specific support. To date, CCRM Australia has collaborated with researchers to advance their regenerative medicine technologies, evaluated and supported promising technologies to secure investment funding, facilitated commercialisation training, and worked with international biotechnology companies to establish their clinical trials in Australia. CCRM Australia continues to do so, providing access to resources and expertise from other CCRM Hubs worldwide. 

Learn more at: https://ccrmaustralia.com.au

Press Contacts

Tanguy URENA
Business Development Officer, INITS
t.urena@inits.fr

Dr. Chih Wei Teng
Vice President, Corporate Development, CCRM Australia
chihwei.teng@ccrmaustralia.com.au