Thrive with total compliance
Formulation of Therapeutics including Supplements
Finding a consultant to assist with the formulation of therapeutic products and supplements, customized to meet the specifications of your manufacturing equipment is very difficult. Our Consultants can assist you in this area and formulate various dosage forms including tablets, hard and soft gel capsules, powders, liquids, and creams.
Safety Data Sheets (SDS) and Product Labeling.
Safety Data Sheets are vital for assessing potential hazards in the workplace. All manufacturers and importers of chemicals must also ensure that they are using compliant Safety Data Sheets.
Product Labeling can be confusing and difficult for those without experience with this aspect of regulatory affairs. Our consultants regularly deal with preparing compliant labeling across a wide variety of products such as therapeutic goods (medicines and devices), foods and beverages, cosmetics, agricultural items, poisons and other hazardous substances.
Our consultants are well-versed in compliant SDSs, so contact us today for assistance with understanding the requirements and processes around their use.
Everything you need to know about work (in some states known as occupational) health and safety. Our consultants in this area are well-versed in the requirements of having, storing, using, transporting and disposing of dangerous goods and hazardous substances. We prepare and review safety data sheets (SDS), guide you through product labelling, conduct site safety assessments and advise on laboratory environments.Or, get in contact with use so we can assist your enquiry directly.
Goods Manufacturing Practice, Compliance & Licencing
Do you manufacture therapeutic or veterinary goods? As you’re aware, you need to comply with the quality systems regulated by the Therapeutic Goods Administration, the APVMA and/or the Pharmaceutical Inspection Co-operation Scheme (PIC/S). We can develop your procedures and manuals that ensure you comply with the regulations, as well as conduct deficiency response audits and train your staff.
Assistance in establishing compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). Other associated services include:
- Facility design and licensing
- Pilot batch manufacture
- Facility upgrades and improvements
- Validation Master Plan (VMP) and execution
- Quality Assurance (QA) and Quality Management Systems (QMS)
- Audits and inspections
- Equipment qualification
- Process validation
- Analytical method validation
- Contamination control
- Product Quality Reviews
- Release for supply
A Compliant Website
It is essential that your website’s content is consistent with the relevant claims, registered indications and/or intended purposes of your products as required by the relevant regulatory body in Australia.In all cases, the Australian Competition and Consumer Commission (ACCC) requires that products are “fit for purpose” and that advertising and web content make accurate and fair representations for the product when used according to instructions.
Our consultants are well-versed in the requirements for advertising products on websites. We can assist you in ensuring your website is compliant when advertising:
- Therapeutic Goods, both medicines and medical devices (regulated by TGA)
- Cosmetics (regulated by AICIS and ACCC)
- Agricultural and Veterinary Products (regulated by APVMA)