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)
Products
APVMA Registration Consulting
Regulatory consulting services for agricultural chemicals, herbicides, pesticides, and veterinary medicines to ensure compliance with the Australian Pesticides and Veterinary Medicines Authority (APVMA).
FSANZ Food Compliance Consulting
Regulatory consulting services to ensure food and beverage products conform to standards set by Food Standards Australia and New Zealand (FSANZ), including nutritional and labelling requirements.
ChemSkill Regulatory Affairs Consulting
Expert regulatory compliance assistance and consulting services.
Therapeutics and Supplements Formulation Consulting
Consulting services to assist with the formulation of therapeutic products and supplements, customized to meet manufacturing equipment specifications across various dosage forms.
Compliant Website
Regulatory consulting service ensuring website content aligns with relevant claims, registered indications, and intended purposes of products as required by Australian regulatory bodies.
Therapeutic Goods Regulatory Consulting
Specialised registration and listing services for therapeutic goods including pharmaceuticals, biologicals, topical products, and medical devices to ensure compliance with the Therapeutic Goods Administration (TGA) and the Australian Register of Therapeutic Goods (ARTG).
APVMA Registration Consulting
Regulatory consulting services for agricultural chemicals, herbicides, pesticides, and veterinary medicines to ensure compliance with the Australian Pesticides and Veterinary Medicines Authority (APVMA).
FSANZ Food Compliance Consulting
Regulatory consulting services to ensure food and beverage products conform to standards set by Food Standards Australia and New Zealand (FSANZ), including nutritional and labelling requirements.
ChemSkill Regulatory Affairs Consulting
Expert regulatory compliance assistance and consulting services.
Therapeutics and Supplements Formulation Consulting
Consulting services to assist with the formulation of therapeutic products and supplements, customized to meet manufacturing equipment specifications across various dosage forms.
Compliant Website
Regulatory consulting service ensuring website content aligns with relevant claims, registered indications, and intended purposes of products as required by Australian regulatory bodies.
Therapeutic Goods Regulatory Consulting
Specialised registration and listing services for therapeutic goods including pharmaceuticals, biologicals, topical products, and medical devices to ensure compliance with the Therapeutic Goods Administration (TGA) and the Australian Register of Therapeutic Goods (ARTG).
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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