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Regulatory affairs

Regulatory excellence and agility are a central theme of customized development of device-drug combination products. Successful projects depend on a smart and robust regulatory strategy.

Typically, each combination product requires a customized strategy to address all special requirements for the targeted medical indications, the intended purpose of the device, for each target market and regulatory environment. 

Hemoteq product development and regulatory specialists will team up with our customers´ organization to master the complexity of the approval process, to conceive and implement an optimized regulatory strategy. As a team, we permanently adapt and fine-tune our strategy during the course of every project and regulatory submission phase, leveraging expertise in working with regulatory and competent authorities and notified bodies around the globe.

After approval, we support our clients´ regulatory filings in additional geographies and obligatory post-market activities.