From concept to commercialisation.

We offer individualised services at our 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 Drug Delivery Systems for oral and topical products – as NDAs, 505(b)(2) and generics – for the global market for over 40 years. Our specialties include:

  • Animal studies, pre-clinical and small batch manufacture
  • Phase I clinical –first time in man
  • Phase II and III support – outcome focussed formulation and scale-up dependent on trials
  • Registration and exhibit batches manufacture
  • Modified release capsules and tablets – pulsed, sustained, delayed and enteric
  • Fluid bed spray and rotor granulation
  • High shear granulation and mixing
  • Extrusion/spheronisation
  • Taste-masking
  • Spray drying – to enhance bioavailability and improve side-effect profile
  • Fluid bed polymer coating – top spray and bottom spray Wurster coating
  • Milling and sieving
  • Tablet compression and film coating
  • Encapsulation – powders and pellets
  • Formulation development, physical characterisation and packaging of topical products, including creams, lotions, ointments and gels at lab and pilot scale
  • Homogenisation for liquid suspensions and creams
  • Temperature-controlled stability storage facilities
  • IBC options

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Analytical
Development

Using best practice techniques and procedures, our agile and responsive analytical team offer chemistry support for formulation development, including:

  • Raw material testing, product characterisation and stability assessment
  • Analytical method development, validation and optimisation of complex test procedures
  • Bidirectional analytical method transfer
  • Testing of scale-up, exhibit and clinical trial manufacture up to commercial scale batches
  • Preparation of GMP documentation and reports
  • Compendial verification and qualification
  • Cleaning validation and development
  • Transfer of analytical procedures (receiving and sending)
  • Assisting with regulatory submission and clinical trial manufacture

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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 – solid, semi-solid, liquid and topical product
  • Packaging – solids, semi-solids and liquid products
  • Special handling – high potent compounds and controlled substances
  • Serialisation
  • Elemental impurities
  • Stability storage and testing:
    • 25°C /60% RH, 30°C /65% RH, 30°C /75% RH, 40°C/75% RH
    • 5°C storage facilities
    • 25°C and 30°C ambient storage facilities
    • Manage other required stability conditions through established service providers
  • Raw material testing and release
  • Microbiology services
  • Distribution and logistics services
  • Procurement – packaging and materials
  • Product enhancement – reformulation, process development
  • Validation – process, cleaning and equipment systems

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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 2666.