The majority of the healthcare products need to be registered with regulatory authorities before they can be marketed in a local market, these include medicines and medical devices.
Other healthcare products such as health supplements and cosmetics may or may not need to be registered with regulatory authorities depending on the local regulation requirements in that particular country. Although in some countries these types of products are not required to obtain a formal registration approval, the products are always required to meet the local regulatory requirements to ensure compliance.
At APPharma, we act as a regulatory consultant, we are utilising our scientific minded approach and extensive regulatory and compliance experience to best serve your business. We are focused to help you achieve maximum business goals in a cost-effective way.
- Development of registration strategies
- Preparation of regulatory submissions
- Registration submissions with regulatory authorities and follow-ups
- Local representatives
- Acting as an agent for registration submissions and liaising with the regulatory authorities
- Acting as a sponsor (marketing authorisation holder) to hold your product registrations if you do not have a local legal entity in Australia
- Feasibility studies
- Dossier evaluation & gap analysis
- Data requirements
- Registration pathways
Daily Regulatory Activities
- Addressing questions from regulatory authorities
- Solutions for regulatory issues
- Review of labelling, promotion materials, etc.
- Compiling & reformatting dossiers
- Compliance review
- Regulatory operations such as regulatory processes, records management, etc.
- New product registration applications
- Product registration maintenance, and variation applications
- New substance (new ingredient) applications
- Reclassification (rescheduling) applications
- GMP licence and clearance applications
- Wholesale licence applications
- Promotional material approvals
- Other regulatory or technical submissions with government organisations or industry bodies (e.g. industry consultation, industry issues, etc.)