Services

Australia/New Zealand

Regulatory Classification of your product (ANZ)	Regulatory Classification of your product – PRC can provide you with a unique service of evaluating the classification of your product and identifying the registration pathway. We will check the active ingredients for compliance with current legislation and guidelines, examples such as: SUSMP (Standard for Uniform Scheduling of Medicines and Poisons) Permissible Ingredients Determination 26BB RASML, Guidelines ARGOM, ARGCM and ARGMD Therapeutics goods orders (where relevant) Dangerous Goods Codes (where relevant) MEDSAFE and ERMA standards and FSANZ standards (where relevant) *We provide you with a report outlining the next steps toward developing a strategy Prices from $995 depending on the complexity of the project an initial 3-5 hours.**
OTC Medicine applications (Non-prescription Medicines)	PRC can assist you with your registration needs for Over-the-Counter Medicine applications – both for new product applications and variations to existing products. We can assist you by working alongside you and assisting you with the entire process, including registering sponsorship with the TGA or MEDSAFE and communicating with your manufacturer. We will guide you with all regulatory requirements including the latest ICH stability requirements, In vitro diagnostic Regulatory Guidelines for Over the Counter Medicines (ARGOM) and Therapeutic Goods Orders – as an example TGO 92 Labelling of non-prescription medicines. PRC is particularly experienced in labelling (over 20 years experience) and finding solutions to full-filling labelling regulatory requirements as well as satisfying commercial requirements.
*Medical Devices and IVD applications**	PRC can assist you with your registration needs for Medical Device applications or IVD applications – both for new product applications and variations to existing devices. We can assist you by working alongside you and helping with the entire process, including registering sponsorship with the TGA or MEDSAFE and communicating with your manufacturer. We can guide with all regulatory requirements including the latest TGA Guidelines such as the Australian Regulatory Guidelines for Medical Devices (ARGMD)
Complementary Medicines applications	PRC can assist you with your registration needs for Listed/ Complementary Medicine applications – both for new product applications and changes to existing products. We can assist you by working alongside you and helping with the entire process, including registering sponsorship with the TGA or MEDSAFE and communicating with your manufacturer. We can guide with all regulatory requirements including the latest TGA Guidelines such as the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) and TGO 92 Labelling of non-prescription medicines.
Product Labelling	PRC can assist you with current medicine labelling legislation and best practice We can ensure that your labels are compliant to medicine regulations such as TGO 91 and TGO 92 and demonstrate how to present your labels according to Industry best practice. PRC is also familiarised with CHP and Medicines Australia best practice for labelling and advertising.
Cosmetics	PRC has broad experience and background working with a number of household good companies and experience with well-known big brands. We can assist you with the review process of a proposed cosmetic to be marketed in Australia or New Zealand- starting with the review of your formulation and technical file and checking ‘every single ingredient’ to ensure they are compliant. There are multiple legislative instruments that need to be checked – such as ingredients listings on AICS with the National Industrial Chemical Notification Assessment Scheme (NICNAS). SUSMP and TGA legislation
Packaging and Specifications	PRC can assist you with the quality aspects of your medicine as our members come with a strong background in product development and quality so we understand the importance of getting it right the first time. The Quality dossier (Module 3) of a new medicine must be compliant to the relevant accepted standards such as TGA adopted ICH guidelines and other TGA guidelines (for example ARGOM). PRC can review your technical dossier and product specifications - this can be undertaken as an independent gap analysis or as part of the due diligence for a new product registration.
General advice	PRC can provide advice regarding Therapeutic Good registrations, product variations and market approval applications for Over the Counter (OTC) Medicines, Medical Devices and Complementary Medicines as well as assisting clients with other therapeutic goods areas. Our broad experience in a range of therapeutic areas presents a strength in regards to the classification of therapeutic goods and general products. PRC can assist you in classifying your product, therapy area and registration pathway early on in the project.
Due diligence/Feasibility Analysis	PRC can review your technical dossier and specifications and conduct a gap analysis to determine gaps in your dossier and identify the additional requirements in preparation for an application. We provide a report that will include a conclusion as to the feasibility of the project.