Highly Regulated Industries

pharmaceutical industry


The pharmaceutical industry is one of the most highly regulated industries in the world, where compliance is of the utmost importance not only to the companies who manufacture the products but the customers who depend on them for their life, health, and wellbeing. Clients in the pharmaceutical, biotech, and nutraceutical sectors require expert advice in the design, construction, and operation of their facilities. 

Synertec has its foundations in the pharmaceutical industry and for more than 20 years have been serving clients with detailed design, implementation, fabrication, validation, compliance, training, ongoing support, and concept & feasibility studies in Good Manufacturing Practice (GMP).

Our experience with GMP regulations, end-to-end design, construction, and validation provides our clients with premium value and complete solutions. We provide specialist expertise in:

  • Process & mechanical engineering
  • Construction management
  • Production modelling
  • Compliance & validation

Certification and compliance is a must in the sector, and we are proud of our record in this regard. Synertec is accredited to ISO9001 for work in the pharmaceutical and biotech industries. Our systems are also routinely subjected to audits by some of the world’s most respected pharmaceutical companies for compliance against regulatory agencies such as the Office of the Gene Technology Regulator (OGTR), Australian Quarantine and Inspection Service (AQIS), United States Food and Drug Administration (USFDA), Australian Therapeutic Goods Administration (TGA) and Malaysian authorities. Moreover, our work has passed many real-world audits by those same regulatory agencies.

One of our longest served industry sectors, Synertec is recognised as an industry leader within the Life Sciences for engineering as well as compliance and validation services. Our Quality & Validation team comes with extensive consulting experience within GMP-regulated departments of pharmaceutical companies.

Partnering with Synertec brings efficiencies and improved outcomes because we provide all GMP critical systems in-house under the one system of management, quality, and validation.

Core Capabilities

  • Pharmaceutical manufacturing facilities
  • Clean room environments
  • Research laboratories
  • Storage facilities
  • Computer system validation
  • Utilities design, commissioning, and validation
  • United States Food and Drug Administration (USFDA), European Medicines Evaluation Agency (EMEA), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and Pharmaceutical Inspection Co-operation Scheme (PIC/S) 
  • Good Manufacturing Practices (GMP) with their regional interpretation by Therapeutic Goods Administration (TGA), Medsafe, and the National Pharmaceutical Council (NPC)

Relevant Experience 

Synertec’s engineering team has been involved in major projects around the world delivering state of the art pharmaceutical manufacturing facilities.

Recent clients include:

  • CSL
  • Merck Sharp & Dohme
  • Pfizer
  • ANSTO (nuclear medicine facility)
  • Ego Pharmaceuticals
Woomera, South Australia - May 15 2019:Woomera Missile Park.Woomera town was home to personnel who worked between 1947-1980 in experimental station to test rockets, weapons and missiles in South Australia

Fuel Installations - Defence

Already a highly regulated industry, adding the stringent requirements of the Defence sector brings another layer of complexity to fuel installations. Synertec is a proud member of the Defence Infrastructure Panel (DIP) for Fuel Installations, in recognition of our design and project capability managing the complexities and risks of fuel farm installations.

Our engagement with the Department of Defence and its prime contractors is to deliver engineering design and construction management to a range of bulk fuel and process installations around Australia.

We support our partners by providing services in fire, civil, and structural design. Our personnel have a wide range of skills and expertise encompassing engineering, quality assurance, construction, and manufacturing, offering clients the broadest possible perspective on any industrial or defence challenge.

Core Capabilities

  • Bulk fuel & liquid installation design
  • Hazardous area classification & design
  • Automation & control systems
  • Functional safety systems
  • Project management
  • Construction management
  • Process & mechanical engineering
  • Process optimisation & scale-up
  • Compliance to Australian and International safety & environmental regulations
  • Project planning studies

Relevant Experience 

Synertec offers a wealth of experience in the Defence sector. Notable projects include the Defence Fuel Installation (DFI) upgrade at Woomera, which is used for the testing of war material under the control of the Royal Australian Air Force. Covering nearly 124,000 square kilometres in north-west South Australia, Woomera is the largest testing range in the world. 

The project team were hand-picked based on the diverse skill set required on site, including project management, engineering, site supervision, and hazardous areas.

The team resolved various challenges that emerged throughout the course of the project, delivering the project on-time and on-budget.

beer bottles on the conveyor belt

Food, Beverage and Dairy

The food, beverage, and dairy industry is high risk and highly regulated, and it exposes clients to extreme reputational risk. Synertec’s engineering team works closely with major food, beverage, and dairy facilities around Australia to provide process engineering and control system solutions for the specialist processes required in these industries.

Synertec’s services for food, beverage and dairy applications include:

  • Process & mechanical engineering
  • Automation, instrumentation & control
  • Construction management
  • Production modelling

Core Capabilities

  • Programmable Logic Controller (PLC) systems
  • Supervisory Control And Data Acquisition (SCADA) systems
  • Safety control systems
  • Bulk liquid storage & handling
  • Research laboratory design & construction
  • Clean room environments
  • 2D & 3D drafting / modelling
  • Tank & piping design
  • Project management
  • Construction management

Relevant Experience 

Clients within the food, beverage, and dairy industry include Snow Brand Australia who engaged Synertec to complete a site based hazardous area inspection at the company’s premises in Tatura.

The project demonstrated Synertec’s detailed knowledge and understanding of Australian Standards (e.g. AS60079: Electrical equipment for explosive atmospheres and AS3000: Wiring rules) for the application of explosive dusts such as milk powder.