Pharmaceutical
In addition to the core professional services, we can enable opportunities for your pharmaceutical or biotech organisation. Based on your particular needs, we provide a bespoke service for every client, covering aspects such as:
Compliance with relevant regulatory standards: TGA, FDA, EMA or MHRA
Plant design & configuration for new build, expansions or retrofits
New product introduction coordination
Project management
Process control and automation
Operational Excellence
Preparatory or periodic GMP audits
Product or process validation – new equipment, revalidation & lifecycle management
Process deviation or out of specification investigations
Data integrity assessment with associated solution implementation
Balancing the growth and development of your business while maintaining strong everyday operation is difficult. With industry operational leadership experience across natural products, API, Secondary packaging, Biological and vaccine products, Castles Keep Consulting can support your venture or operation. Please get in touch to find out how.
Clinical Trials
Australia is a desirable location to undertake clinical trials, especially Phase I first in human studies. Consequently, many biotech companies from around the world preference Australia for Phase I trials. All biotech companies must invest significant effort to initiate a trial and establish a supply chain. This can be even more demanding if the business is offshore to Australia. Wherever your business is located, we can be part of your team helping you work towards ensuring a timely and effective trial.