Regulatory Affairs departments need to be efficient, have stable business processes and support systems in place. The regulatory space is complex and challenged in many ways, just think of complying to different regional regulatory requirements, handling of submissions depending on product type and procedure type, managing stakeholders, and tracking of registration data while struggling to ensure the right resources are aboard to facilitate on time submission.
Our regulatory consultants understand both change oriented and operational challenges in RA. Whether it relates to regulatory process optimization, implementation of regulatory systems, understanding Health Authority requirements or lending a hand during submission peak periods - we are ready to help.
We understand the requirements for data & document submission and strive to ensure that systems support the regulatory processes. From defining regulatory roadmaps for system implementation to regulatory operations, our experts can fill knowledge gaps, enhance your regulatory department's competences as well as perform operational tasks as needed.
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Our team has profound experience in assessing AS-IS and outlining TO-BE processes in connection with business process optimization, regulatory system implementation and other changes to the organization.
Process services may include:
Digital transformation in Regulatory Affairs depends heavily on successful implementation and usability of regulatory systems. Our team has in-depth experience ensuring dedicated business SME input for your implementation project.
Our IT System Implementation services expertise:
The topic of ensuring reliable exchange of regulatory data between Health Authorities and their stakeholders has been an important topic for decades. As IT systems become more mature it is still expected that providing and maintaining product data following the regulators' requirements fall under Marketing Authorization Holder responsibility. Getting in control and building trust in data is an important step on the way. Our regulatory consultants provide data standard services including
Data Standard services include:
At the end of the day, it is the day-to-day business operation that ensures your company’s productscomply with regulations. In a changing world there will be times where additional expertise is needed and our regulatory consultants can provide thistype of support.
Operations services can include:
We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.
