ChemSkill
ChemSkill Regulatory Affairs Consulting specializes in helping clients meet Australian regulatory requirements across various sectors including Therapeutic Goods, Industrial Chemicals, Cosmetics, Food & Beverage, and Pesticides & Veterinary Medicines. They offer services such as compliance consulting, formulation of therapeutics and supplements, SDS and product labeling, website compliance, and more, with a focus on current legislation and confidentiality.
Industries
Nr. of Employees
small (1-50)
ChemSkill
Services
Regulatory assessment and preparation of submissions for national regulators covering medicines, devices, industrial chemicals and cosmetics; interpretation of legislative reforms and requirements.
Formulation of various dosage forms tailored to client manufacturing equipment and specifications.
Preparation and review of compliant SDS documents and product labels for a range of regulated product categories.
Advice on safe storage, handling, transport and disposal of hazardous substances, site safety assessments and laboratory environment guidance.
Development of GMP/GLP procedures and manuals, validation planning and execution, facility design support, audits and staff training to meet manufacturing and laboratory regulatory standards.
Review of website content and advertising for consistency with permitted claims, registered indications and national consumer protection rules for regulated products.
Regulatory assessment and preparation of submissions for national regulators covering medicines, devices, industrial chemicals and cosmetics; interpretation of legislative reforms and requirements.
Formulation of various dosage forms tailored to client manufacturing equipment and specifications.
Preparation and review of compliant SDS documents and product labels for a range of regulated product categories.
Advice on safe storage, handling, transport and disposal of hazardous substances, site safety assessments and laboratory environment guidance.
Development of GMP/GLP procedures and manuals, validation planning and execution, facility design support, audits and staff training to meet manufacturing and laboratory regulatory standards.
Review of website content and advertising for consistency with permitted claims, registered indications and national consumer protection rules for regulated products.
Expertise Areas
- Regulatory compliance for therapeutic goods (TGA and ARTG processes)
- Industrial chemicals regulation and AICIS notifications
- Cosmetic product regulatory compliance
- Agricultural and veterinary chemical registration (APVMA)
Key Technologies
- Formulation development (tablets, capsules, powders, liquids, creams)
- Analytical method validation
- Process validation
- Quality management systems (GMP/QMS)
News & Updates
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