From concept to commercialisation.
Watch how we do it
We offer individualised services at our South Australian GMP-accredited manufacturing facility, with the proven ability to successfully assist you at every stage – from small-scale formulation development and analysis, through to technology transfer and commercial manufacture.
Comprehensive services and capabilities.
Pharmaceutical Development
We have been successfully developing oral and topical products for the global market for over 40 years.
Our specialties include:
- Formulation development and scale up from concept to commercialisation including:
- Modified release capsules and tablets
- Bioavailability enhancement using spray drying technology
- Fluid bed coating and granulation
- Extrusion and spheronisation
- Taste-masking
- Tablet compression and film coating
- Liquid and semi-solid
- Small scale batch manufacture suitable for animal or pre-clinical studies
- Clinical trial manufacture for phase I, II and III studies
- Bidirectional technology transfer of products and processes
- Pivotal clinical and stability batch manufacture
- Licenced to handle and manufacture controlled drug products
- Potent compound handling capabilities
Analytical Development
Using best practice techniques, our agile and responsive team has extensive analytical expertise, offering support for all stages of pharmaceutical development.
Our specialties include:
- Raw material testing and verification of compendial methods
- Product characterisation (physical and chemical) and stability assessment
- Analytical method development and optimisation of complex test procedures
- Analytical method qualification and validation
- Cleaning method development and validation
- Bidirectional analytical method transfer
- Testing of development formulations, scale-up, exhibit and clinical trial batches
- ICH stability storage and testing
- Preparation of submission ready GMP documentation and reports
Commercial Manufacturing & Technical Services
We offer extensive contract services for upscaling new formulations into commercial scale production, as well as managing the technology transfer of existing products and line extensions.
Our capabilities include:
- Manufacturing and packaging of solid, semi-solid and liquid products
- Licenced to handle and manufacture controlled drug products
- ICH Stability storage and testing
- Full QC services including raw material, intermediate and finished product testing and release
- QA release for distribution or release for sale
- QA services such as vendor assurance/audits and annual product quality reviews
- Microbiological services
- Procurement services – packaging and raw materials
- Product enhancement – reformulation and process development
- Validation services– process, cleaning and equipment
Experience and
service
you can trust
Individualised services
Agile and highly-skilled team
Dedicated project manager
Specialist facilities and world-class expertise
How may we help you?
Fill out the form below or call us on +61 8 8209 2453 to discuss your pharmaceutical project needs.
Please note no enquiries for job applications are accepted via this form. Please see here for the current job opportunities available at Mayne Pharma.
