Our team of consultants provides specialised expertise and guidance to companies, researchers, healthcare institutions, and regulatory bodies involved in the development, manufacturing, regulation, and commercialisation of advanced therapies. We can help you in navigating the complex landscape of scientific, clinical, regulatory, and commercial challenges.
We can assist with the integration of advanced digital technologies, data analytics, and automation to enhance various aspects of research, development, manufacturing, and patient care to optimize processes, improve patient outcomes, accelerate innovation, and ensure regulatory compliance.
Our services offerings include:
- Quality Assurance and QMS Development:
- Current Good Manufacturing Practice (cGMP) compliance: our consultants can help our clients establish phase appropriate cGMP-compliant manufacturing facilities and quality systems to ensure safe and consistent production of therapies.
- Working with our network partners, we can offer expertise in developing and optimizing manufacturing processes for advanced therapies. This includes cell expansion, gene editing, viral vector production, and quality control.
- Regulatory Guidance:
- Our Regulatory experts can help clients navigate the complex and evolving regulatory landscape for tissue, cell, and gene therapies. This includes interactions with regulatory agencies such as the Australian TGA, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
- Risk Management:
- Our consultants can help our clients establish risk management plans and quality assurance systems to ensure product safety, efficacy, and compliance throughout the therapy lifecycle.
- Education and Training:
- We can offer specialised training programs and workshops to educate clients about the fundamentals of tissue, cell, and gene therapies, as well as the latest developments and best practices.
- Clinical Trials:
- Our team are industry experts on cell and tissue collection. We work in collaboration with clinical trial Sponsors to ensure starting material collected for further processing is done in accordance with all local Regulatory requirements but also that the product collected is optimum for downstream manufacturing success.
- Scientific Expertise:
- Working with our partners, we can provide access to experts in the fields of molecular biology, genetics, immunology, and other relevant disciplines. We can provide insights into the latest scientific advancements and help clients design and optimize their therapy development strategies success.
Contact us and discover how we can play a pivotal role in accelerating the translation of your cutting-edge science into safe and effective treatments, ultimately benefiting patients and advancing medical innovation.
