Business Areas

Regulatory​ Affairs

Ensure compliance success by leveraging the expertise of regulatory professionals

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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Anne Pouzet

Regulatory Processes

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:

  • Business processgap & impact assessment
  • Business process re-modelingand establishment
  • Advice on best practice on quality level, governance, and scope
  • And more

IT System Implementation

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:

  • Project preparation (e.g., data model design, document type scoping & master data requirement)
  • Advise and testing during configuration phase
  • Test script review
  • Data and document preparation for migration
  • End user training
  • Business administration support during hyper care
  • And more

Data Standards

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:

  • Capability building around requirements for XEVMPD (Extended Eudravigilance Medicinal ProductDictionary) and IDMP (Identification of Medicinal Products)
  • IDMP readiness analysis
  • Identification of activities needed to meet future requirements for IDMP
  • Establishment of productmaster data governance
  • Build productdata knowledge in the organization
  • And more

Regulatory Operations

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:

  • Document Management
  • Submission Management
  • Publishing andtroubleshooting eCTD validation criteria
  • Data preparationand Submission (XEVMPD)
  • RA systems managedoperation
  • Business SME assessment of system periodic updates
  • And more

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We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.