Regulatory Strategy

MakroCare helps companies define Regulatory strategies for their medical devices and diagnostics right from the product development to life cycle management to address different pathways & submission requirements utilizing our global scientific, regulatory and technical experts.

You can leverage our experience of 20+ years gained from successful regulatory projects spanning 80+ countries. Our proprietary regulatory requirements database combined with regulatory experts provide customized experience

Our Role

Our comprehensive regulatory advisory services ensure faster approvals and risk minimization.

Regulatory pathway and scenarios
Regulatory Strategies for global filing of your medical device or diagnostics to reduce time-lines for launching of products into market.
Agency pre-discussions (FDA Q-Sub and others)
Strategies for commercializing products approved in one region to another region (e.g USA to Europe or vice versa)
Opinions/advice on the impact of current, newly finalized or proposed regulations, guidelines and standards and make recommendations accordingly.
Provide operational direction in Product Life-cycle Planning, facilitating registration of products.
Legislation/regulations, processes and time-lines
National/regional differences
Regulatory precedence

Why MakroCare?

Your regulatory strategy should be different for each product, and should be developed with your business objectives in mind. As experts in Medical Device regulatory consulting for EU, US and global markets, MakroCare will work with you to develop an appropriate and effective strategy to get your product to market faster and staying compliant. Our experts will combine knowledge of your product with years of experience. The final regulatory strategy for your product will balance risk, speed to approval, and cost to provide you with the most appropriate regulatory path.