Brandwood Biomedical provides technical, regulatory and commercial advisory services to support the whole product life cycle, from Investment Due Diligence/Investment Readiness to development and implementation of a global regulatory strategy. Like the industry which we serve, we operate in a global marketplace, with capabilities to manage regulatory submissions in multiple jurisdictions including Europe, the Americas and Asia.  We have strategic partnerships in the US and Europe and our own office in Hong Kong, with our Singapore office opening shortly.

Our Principal, Dr Arthur Brandwood has over 25 years experience in the medical technology field in commercial product development, and in government including as Director of Devices Registration and Assessment, and of the Biomaterials and Engineering Laboratories at the Therapeutic Goods Administration – the Australian national regulatory authority for medical devices and pharmaceuticals.

 

Regulatory and reimbursement approvals are essential for your market access.  Brandwood Biomedical provides an unrivalled combination of extensive product development technical expertise with detailed knowledge of current risk based regulatory requirements and procedures.  We will work with you to develop the strategy, implement compliance and get to market.

Strategy  A customised strategy and our global expertise and resources will help eliminate regulatory obstacles at all stages of your product’s life cycle. This allows you to focus on achieving what’s important-selling your product.

Compliance Effective management of your product or company-wide compliance program will maximise the time your product has to return revenue, and grow your company’s reputation.

Market Access Leveraging our strong working relationships with global regulators will facilitate a faster and easier route to market approvals and reimbursement and earlier revenue stream.

We can help with all aspects of regulatory compliance including risk assessments, design controls, preclinical and clinical evaluation, quality systems and reimbursement.  We can also assist in postmarket compliance including adverse event reporting and recalls management.  Click here for details of our services and capabilities.