Welcome to Metabio

Specialists in Biopharmaceutical Development and Manufacturing

Services

Metabio offers expertise at the strategic, process and technical levels of bioanalytical, biostatistics, CMC, quality and biomarkers.

Working in isolation or collaboratively as part of your cross functional team of experts, metabio specialises in understanding each project's unique objectives and ensures that an appropriate balance of risk, cost, evidence and compliance is applied across the entirety of the project.

Biostatistics

Metabio provides comprehensive analytical solutions from method development and validation to sample analysis and data interpretation, ensuring the safety, efficacy, and quality of your products throughout the development pipeline.

Services include:

  • Data mining for biomarker identification
  • Early PK/PD studies
  • Clinical trial design and analysis
  • Design of Experiments for process improvement
  • Product stability analysis
  • Statistical process control
  • Specification setting

Bioanalytical

Metabio provides comprehensive analytical solutions from method development and validation to sample analysis and data interpretation, ensuring the safety, efficacy, and quality of your products throughout the development pipeline.

Services include:

  • Method development and validation
  • Sample analysis
  • Data interpretation
  • General and pharmacopeial laboratory tests
  • Advanced screening and targeted assays using chromatography, spectroscopy, immunology, and mass spectrometry

CMC

Metabio supports your development journey by applying current industry standards to ensure a compliant and consistent approach to product and process development strategies, leading to successful regulatory submissions.

Services include:

  • Process and manufacturing strategy/development
  • Analytical development
  • Troubleshooting
  • Quality CTD content for health authority submissions
  • Management of third-party processing/labs

Quality

Metabio provides quality assurance and control services to ensure the safety, efficacy, and consistency of your pharmaceutical products from early development to commercialisation.

Services include:

  • Quality assurance
  • Quality control
  • Risk management
  • Balancing quality assurance, control, and risk to meet objectives efficiently

Biomarkers

Metabio provides customised proteomic and metabolic biomarker services for the pharmaceutical industry, covering the entire pipeline from marker discovery to commercialisation.

Services include:

  • Marker discovery
  • Analytical development and validation
  • Clinical validation
  • Statistical data analysis
  • CMC/regulatory compliance

About Metabio

A specialist consultancy group bringing global pharmaceutical expertise to biotech start ups, academic institutions and small to medium pharmaceutical companies.

Our team of pharmaceutical industry experts, provide tailored solutions to assist our clients in navigating the complex landscape of biomarker and therapeutic development.

With over 50 years of combined experience in satisfying the regulatory requirements of authorities such as the FDA, TGA and EMEA, we empower our clients to accelerate their research, optimise their preclinical strategies, and maximise the potential of their therapeutic and biomarker candidates.

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Contact

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