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STRATEGIC PLANS

There is an increasing need to perform clinical studies to support device safety and performance claims. Donawa Lifescience Consulting (DLC) understands that careful strategic planning and awareness of local regulations are critical to ensure timely study approval and successful completion of European studies.

Whether a study involves a CE-marked product, a new product or new indication of an existing product, DLC develops strategic plans, which address the key regulatory issues related to your medical device and the steps needed to successfully complete clinical testing while minimizing time and costs. 

In addition, DLC can assist you in developing clinical study dossiers in compliance with EN ISO 14155, and which meet European and local regulatory requirements, as needed to obtain rapid study approval from Ethics Committees (ECs) and Competent Authorities.

For example, variations exist among sites and member states regarding the submission procedure and type of documentation required. We will help you to optimize the presentation of your dossier to clearly outline compliance with applicable scientific criteria, international standards and regulatory requirements.

To minimize the time to first patient enrollment, our philosophy is to establish and maintain optimal contact and communication with the Ethics Committees, clinical sites and Competent Authorities. This allows us to address any issue in a timely manner and facilitate a rapid and successful study review.