Regulatory Services

Services we offer:
AUST L product compliance
Use of permitted ingredients
Dossier collation and preparation
Pharmacovigilance review
Product specification development
Analytical method development and validation
Stability studies and shelf-life determination
Label Compliance
Allergen Statements
TGA Compliant
Complementary medicine in Australia is regulated by the Therapeutic Goods Administration (TGA), which has the strictest guidelines for the manufacturing and packaging of supplements anywhere in the world.
Regulatory Services
All manufacturing of Therapeutic Goods must be conducted in accordance with the Therapeutic Goods Act and under the GMP Licence with the TGA. Our Product Development and Regulatory teams work closely with the TGA to ensure our services and operations comply with the latest regulations under Australian law, as well as any changes that may occur. Once a product is launched on the market, it must continue to comply with regulations and may be selected for post-market reviews.
Formulation Appraisal
Our friendly and highly-experienced team conducts free market and formulation appraisals, tailoring solutions to meet your needs.