Regulatory submission support

As competition and increased regulation drive innovation, collaboration between partnerships in a global environment becomes critical to the success of medical device commercialization.

We provide

pharmaceutical and biopharma leaders with insights to reduce regulatory risk and remain compliant. We also evaluate strategic tasks that can help align customers’ regulatory and operational strategies.

We help

customers operate within the new and existing regulations in ways that protect, enhance, and create value, whether its emerging regulations or latest industry best practices.

We work

as a trusted business advisor in partnership with our customers to deliver customized, practical solutions aimed at mitigating current and potential risks to the combination product development process.

Combination product development

ZebraSci has experience in primary container engineering, human factors, medical device commercialization for auto-injectors, needle safety devices and novel drug-device systems. ZebraSci assists organizations in developing combination products – from early concept through commercial launch and post-market monitoring.

Effective product development and commercialization is a central driver of a successful combination product development. Followed by the design control process which is necessary step in developing a combination product. This process confirms that the user needs are met.

ZebraSci aims to show how all these requirements need to be translated into the development activities across the range of drug – device combination products, including prefilled syringes (PFS), auto-injectors, and needle safety devices.

Risk assessment

Innovation involves taking risks. There are several techniques and practices that are designed to reduce these risks. ZebraSci aids organizations in choosing the appropriate tools to help them with their risk management activities. We will support the organization in developing the analytical framework for measuring, managing, and monitoring risks. ZebraSci has experience implementing effective risk management programs for medical device commercialization within small and large organizations, across functions, sites and therapeutic areas, to make risk management a central part of product development.

Risk management is the backbone of effective design control and supports the organizations’ regulatory strategy as well as helps direct the company’s quality planning activities. Risk management is an integral part of producing robust designs within device development and is performed throughout the product life cycle. We aim to institute a risk management process that meets device and drug regulations and helping organizations understand, evaluate, and take action on the appropriate risks with the view to increase the probability of their success.

Human factors engineering

Project management

We transfer the strategies developed for regulatory submission and device technology into operational plans. These plans are developed once we perform an assessment of the organization’s landscape, identify and prioritize gaps, and determine the methods that we will use to execute the strategies.

If you need more information, contact us