Company
About us
Based in Victoria, Australia, we help clients from across the world deliver their clinical trial, by supporting their cGMP manufacture and distribution programs through holistic and agile contract Investigational Medicinal Product (IMP) management services.
The contract IMP specialists
Our dedicated and expert team brings a wealth of experience in IMP management – from phase I right through to phase IV. We will work with you to develop the best solution for your project according to your specific needs and timeframes.
- Contract drug manufacture
- Clinical trial management
- Warehousing & distribution
- Analytical & technical development
- Syntro Pharmacy
World-class capabilities and facilities
Our state-of-the-art TGA licensed cGMP facilities have been purpose built to the highest standards to manage our contract manufacturing, warehousing and distribution services on behalf of CROs, research institutes and biotechs.
- Drugs, poisons & controls licences
- Temperature-controlled storage & shipping
- Bespoke tracking software
- Pharmacy dispensing services
- Global partnerships distributed chains
FAQs
As Syntro is a TGA GMP licenced facility we can receive investigational product irrespective of CTN Status. Investigational Product cannot be shipped to site without the CTN acknowledgment, Syntro storge and distribution staff will confirm this prior to shipping.
Yes, in Australia you are required to place the retest date/expiry date on the investigational product.
Yes we would normally prepare a single label to cover Australia and New Zealand. Our project management team can work with you to coordinate this.
The CUSTOMS (PROHIBITED IMPORTS) Act and Regulations define certain products that require an import permit. Syntro can provide specific advice on whether your product requires a permit. Examples of products that currently require import permits are antibiotics, products of biological origin, anabolic steroids, certain hormones (e.g. Growth Hormone), THC/CBD and drugs of addiction. SYNTRO has import licences for these drugs and can apply for individual import permits on behalf of the Sponsor/Client.
Yes, Syntro regularly acts as the Importer of Record (IOR) for products coming into Australia on behalf of our Clients/Sponsors. We will also assist in drafting, reviewing and provide feedback on import documents. This includes Manufacturer’s Declarations, Commercial Invoices and Packing Slips.
Yes, Syntro routinely ships interstate using a range of vendor-assured couriers. We will recommend appropriate couriers based on the stability and time criticality of your shipments. We also routinely ship internationally to all destinations including South-East Asia, New Zealand and Europe.
Syntro undertakes just in time (JIT) manufacture of finished products for Phase I clinical units across Australia on a regular basis. This includes finished product manufacture, primary packaging and labelling on a per cohort basis. We can supply the stock fully blinded to the clinical site. Manufacture and release normally occurs after the Safety Review Committee (SRC) meeting that recommends the dose escalation. We work closely with the Sponsor, CRO and Phase I clinical unit to make sure the treatments are received in line with the dosing schedule.
