Research & Development

Baxter Laboratories is regarded as having outstanding skills and knowledge in relation to formulation research and development. The product development team understand that innovation is about designing products that connect with the consumer.  It is about creating ideas which ensures that end-user maintains interest in the brand.

The development team is well-educated, experienced, and have excellent expertise in topical formulations and emulsion technologies.  Our rapid, uncomplicated approach allows our clients to access the market quickly.

 

Services

  • development of formulations
  • development of manufacturing procedures and specifications
  • development of analytical methods (including method validation)
  • clinical trial samples and efficacy testing
  • packaging componentry design and in-house graphic design
  • stability and efficacy testing
  • product registration
  • pilot batches and technology transfer
  • batch optimisation and scale up
Research & Development

Regulatory Compliance

Baxter Laboratories offers its clients complete in-house regulatory compliance support.  We provide our clients with periodic updates of the changing regulatory environment, and work with you to ensure that your products are compliant.  We can act as a regulatory agent on your behalf when dealing with government agencies and provide export assistance.

We work with you to ensure that all product indications and marketing claims are scientifically substantiated and to ensure that all packaging text and advertising accords with the legislature requirements of your intended markets.

 

Services

  • TGA listing and registration support
  • acting as agent on behalf of the sponsor
  • manufacturing, packaging and release testing of registration batches
  • stability study design and monitoring using ICH guidelines
  • compilation and maintenance of product dossiers
    provided in the appropriate format
  • validation. validation master plan, protocols and reports
  • complete technical support
  • export assistance
Regulatory Compliance

Production

Baxter Laboratories continues to invest in state-of-the-art equipment for the Production Departments.  We have exceptional mixing capabilities for liquid and emulsion products which are all manufactured and filled within controlled environments.  Additionally, we run a lean manufacturing program, including value stream mapping, to enhance efficiencies.

The manufacturing plant has the capability of producing 5000L batches.  The mixing processes are controlled by a validated Allen-Bradley computer system ensuring accurate recording of critical data including weights, temperatures, mixer speeds and time profiles.

 

Services

  • OTC & prescription medicines
  • complementary medicines
  • sunscreen and skin care products
  • tubes (plastic, metal & laminate)
  • bottles, jars, airless, sachets
  • trays, cartons, shelf-ready packaging
  • shrink-wrapping, blister packs
  • tamper-evident seals
Production

Quality

Our quality management system is interwoven into each and every process at Baxter Laboratories.  The quality assurance department entrusts the responsibility of quality onto all personnel within the organisation and uses planning, auditing and quantitative KPI’s to exceed all statutory and regulatory requirements.

Our commitment to quality is recognised throughout the industry as an approved manufacturer of many key brands for our customers.  Additionally, our Quality Control Laboratory, which runs independently to QA, is exceptionally well resourced, ensuring that most test methods are developed, validated and conducted in-house.

 

Services

  • testing and release of raw materials
  • testing and release of bulk and finished product
  • final release to market including marketing authorisation
  • CAPA and deviation management
  • document control and batch control
  • training and vendor assurance
  • validation and maintenance calibration
  • product quality reviews and risk assessments
  • change control
Quality

Logistics

Supply chain management is handled through our internal MRP system. The Purchasing and Planning Department closely monitors production forecasts and communicates regularly with our customers with regard to inventory holdings and delivery dates.  Finished goods are stored in an air-conditioned warehouse and dangerous goods are stored in a segregated dangerous goods store.

We directly import many materials ourselves and work hard to retain strong relationships with our suppliers.

 

Services

  • purchase of raw materials and packaging components
  • direct international procurement
  • vendor qualification program
  • inspection and QC approval of all inward goods
  • temperature controlled GMP finished goods warehousing
  • segregated dangerous goods warehousing
  • global freight logistics and distribution
Logistics
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