Do you need help with compliance services or copy approvals? You may be a start-up, have a bottleneck due to a new product launch or an unexpected staff shortage, and require timely assistance.
Over the years, we have provided services in this area to a wide range of companies across most therapeutic areas. Kim’s experience and expertise is backed up by sound judgement developed over many years.
We can contribute in a number of areas, including:
- Provision of pharmacovigilance and medical information services
- Copy approvals according to Medicines Australia Code of Conduct requirements
- Standard Operating Procedures for medical and compliance functions
- Compassionate use and named patient access programs
- Patient support programs
- Implementation of Risk Management Plans
- Writing or updating Minimum Product Information