Regulatory Advice
The medical device industry is highly regulated which can mean that meeting regulatory criteria can be confusing, stressful and time consuming. That’s why your business needs KD&A.

We provide complete regulatory advice for complete regulatory solutions. We have competitive pricing and will ensure that your needs are met efficiently and effectively.

Regulatory Strategy
To increase your company’s understanding of regulatory requirements, KD&A can develop a regulatory strategy that ensures all requirements and implications are understood from the outset. A well researched and planned regulatory strategy is essential to ensure that your organisation works through applicable regulatory requirements in a focussed and effective manner. Also, a well planned regulatory strategy is extremely valuable for business planning.

Client Focused Services
KD&A will work directly with your company, offering a full range of services to find solutions to your needs. We can work with your company in an ongoing or as needed basis. Our services can be tailored to suit your resources and/or regulatory needs. We are committed to supporting organisations throughout the entire regulatory process, from gaining the necessary accreditations through to maintaining these accreditations. For example, we can attend external audits, negotiate with regulators, complete internal audits, complete staff training and/or any other related regulatory or quality system activity.

Domestic and International Markets
KD&A provides regulatory services that apply to the Australian and International Markets. For the Australian market we provide all advice regarding the Therapeutic Goods Administration. In International markets we provide highly specialised advice for the achievement of the CE Mark (European Union). Further experience will assist your company in gaining regulatory certifications in many countries including Canada (Health Canada) and the USA (Food & Drug Administration).

Other Services
Technical Documentation
Quality Systems
Export Development Assistance
Business Plans, Strategy and Development

Please contact us for a quotation or to discuss your needs. We look forward to hearing from you.

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