Solutions
Holistic drug development
Syntro Health works with clients to help streamline their drug discovery and development programs with our unique full-service Investigational Medicinal Product (IMP) solutions.
Quality & timely IMP management
From drug manufacture to patient delivery
World-class facilities & distribution capabilities
Dedicated project managers & expert pharmacy team
Contract finished product manufacture
We manufacture clinical trial supplies on behalf of CROs, research institutes and biotechs across the world at our purpose-built TGA and cGMP-accredited facilities.
- Phase I, II, III and IV trial supplies manufacture including;
- Tablets, capsules, oral solutions and suspensions, topicals, intranasal etc
- Coordination and management of the manufacture of injectable formulations
- Placebo manufacture to match commercial products
- Packaging and labelling services
Investigational product management
Our expert team brings significant experience in IMP management to assist clients with all stages of their trials.
- Study set up and project planning
- Importer of Record (IOR) services and obtaining permits for import and export of controlled drugs and biologicals
- Review and/or preparation of chemistry and manufacturing documents for regulatory submission
- Protocol and Investigator Brochure review
- Placebo, comparator, concomitant and rescue medications sourcing
- Local and international regulatory and import/export advice
- Pharmacy Manual and Pharmacy File review and drafting
- Prescription template drafting
- Return accountability and destruction services
- Packaging design, advice and procurement
- Blinded and unblinded pharmacy monitoring
Warehousing & distribution
Our storage facilities and shipping capabilities can support the distribution of clinical trials supplies across the globe.
- Cold chain and controlled ambient warehousing and shipping capabilities
- Syntro Connect – our purpose-built inventory tracking software
- Centralised patient dispensing solutions
- Established partnerships with CROs and central depots
Analytical & stability testing oversight
Syntro works closely with its TGA licenced GMP vendor-assured partners for the provision of analytical and stability testing services. Our partners are selected based on their technical capabilities and ability to meet our clients’ timelines. Our team will provide a summary of the analytical requirements commensurate with the clinical phase of your trial.
Activities will include:
- Review of phase I to IV analytical requirements
- Liaison with laboratories to prepare method transfer and validation protocols and reports
- Preparation of ICH stability programs
- Design of in-use stability programs to cover proposed clinical trial medicine use at the clinic
- Microbial testing including standard USP/EP/TGA micro testing and preservative efficacy testing
- Identity testing of incoming drug substances from your third party CDMO, prior to use in clinical studies
Syntro Pharmacy direct-to-patient services
We offer centralised pharmacy services via specialised community pharmacies to provide the dispensing and direct-to-patient requirements of clinical trials and Market Access Programs (MAP’s).
- Pharmacy Board licensed pharmacy
- Centralised pharmacy solution
- Direct-to-patient dispensing
- Patient counselling services
- Coordination and return of unused treatments
- Drug accountability and destruction services
- Preparation and maintenance of Pharmacy Manuals and Pharmacy Trial Files
- Third party monitoring of clinical trials pharmacies to ensure compliance with the study protocol and GCP
