Contract & Support Services

Pharmaceutical Product Development & Packaging

We offer a range of contract services for products from formulation of liquid products and tablets and sachets to complex mixtures to maintain the solubility, stability and bioavailability of drug molecules.
Pharmalab has a wide knowledge of packaging formats that may add value to products or make their manufacture, scale up and regulatory compliance easier.
We are able to conduct trial and prototype work and manufacturing/QA file preparation in our plant on liquid products and offer a similar service in associated plants for tablets and powder products.

Manufacturing

Pharmalab operates a newly licensed EU and Australian (TGA) compliant liquids plant at
EU Grade C.
This enables us to provide contract manufacture of non sterile and terminally sterilised liquid product.
We are associated with a similar plant that provides tablet products.
Pharmalab also has an identical veterinary production licence (Australian National Registration Authority).
Production capability includes bottles, vials, eye drop, tablets, and sterile sachets.

Clinical Trial Samples

We are able to offer low volume manufacturing runs for the smaller amounts of product needed for clinical trials. This manufacturing is fully cGMP compliant and CMC files can be prepared for each product to allow further scale up and transfer to other manufacturing sites.

Stability and Validation of Products

Pharmalab can prepare validation files for client’s production as well as conduct stability trials to ICH Guidelines. Analytical methods are always validated and conducted to USP or EU/BP standards. Our Regulatory Section can work with clients to assist their product dossier development.