services
REGULATORY AFFAIRS
Registering new medicines and medical devices is a lengthy process as high controls and specific regulations apply.
Whether you are a large pharmaceutical company that needs to outsource a single regulatory submission, a small or virtual biotech company with limited regulatory affairs resources, or a dietary supplements manufacturer with a request that does not seem to fit into a regulatory box, our comprehensive understanding of this procedure can bring your product to Australia and New Zealand.
Our Regulatory Affairs team can assist you within the following areas:
- GMP Clearances
- Medicines, Medical Devices and other Therapeutic goods registration and listing
- Cosmetic products regulations
- Food products regulations
- Importing and Exporting
- TGA and Medsafe liaison
- Appeals
- Label and artwork review
- Claims and permitted indications advise
- Advertising and websites complaints management
- Poison licences and scheduling
- Wholesalers evaluation and approvals
- Recalls
- General regulatory advise
COMPLIANCE
Our strength is taking the time to understand your project or product and your goals and then constantly demonstrating creativity and focus in the regulatory arena to overcome obstacles to growth.
We provide market leading knowledge and skills to manage compliance issues efficiently and cost effectively, giving confidence for regulatory inspection.
Our compliance team can assist you within the following areas:
- Compliance internal audits
- Risk Management
- Pre and Post authority inspection assistance
- Manufacturing and formulation advise
- Vendor Assurance implementation
- Quality and GMP agreements
- ISO 13485, QMS for medical devices
- ISO 14971, Risk management for medical devices
- General GMP compliance advise
QUALITY ASSURANCE
Our Quality Assurance expertise and knowledge ensuring adherence to GMP and GDP requirements will ensure that you can manufacture and distribute your products safe in the knowledge that your products are of the highest quality and are fully compliant with the regulations and legal standards.
Our Quality Assurance team can assist you within the following areas:
- Site Master Files
- Quality Manuals
- SOPs creation, revision and implementation
- Process validations and VMP
- QMS creation, revision and implementation
- Batch Release
- Analytical assistance, interpretation of Pharmacopeias and scientific literature.
- Quality internal audits
- Conducting recalls
- Complaint handling
- Manufacturing records
- Equipment maintenance and qualifications
- HVAC system and room qualification
- CAPA system
- Deviations and incidents system
- OOS management
- Annual Product Review
- General quality assurance advise
