RELY ON OUR TEAM

Regulatory Consulting

Put Calyx's experience to work for you.

With nearly 100 collective years’ experience in regulatory operations and compliance, Calyx’s Regulatory Consultants are experts in maneuvering the nuances of the worldwide regulatory landscape.

Rely on our team to help you optimize regulatory processes, meet constantly evolving requirements critical to maintaining product registrations, and keep your products on the market for patients around the world.

READY FOR IDMP?

IDMP: How ready are you?

IDMP will make it easier to mine product data to safeguard patients, ultimately saving patients’ lives. But adopting these standards is a significant undertaking requiring careful planning and coordination across many internal functions and external partners.

Beginning in 2022, life science companies can begin IDMP Iteration 1 submission, with this becoming mandatory in 2023.

Calyx regulatory consulting is here to help. And to give you confidence in your IDMP preparation and compliance strategy.

MEET OUR EXPERTS

Meet the Experts

Extend the deep and diverse experience of Calyx’s highly tenured regulatory experts to your own regulatory team.

Arrange a meeting with a Calyx Regulatory Consultant today.

SCHEDULE TODAY
CALYX-20-Headshots-KarenHarry-FINAL

Director, RIM

Karen Harry

Karen has over 30 years of industry experience in regulatory operations, information management, and compliance, and is currently a member of the EMA SPOR Taskforce supporting the implementation of IDMP iteration 1. As head of Calyx RIM Consulting, she leads a team of regulatory experts who provide strategic regulatory input into the software development lifecycle of Calyx RIM and advise clients on how to effectively manage complex regulatory processes in alignment with the changing regulatory landscape.

 

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CALYX-20-Headshots-AmyWilliams-FINAL

Director, RIM Product Marketing

Amy Williams

Amy has nearly 15 years of experience across various Regulatory Affairs roles, for both global biopharmaceutical companies and their solution providers. As a RIM Director, she leverages her expertise in understanding Calyx customers’ needs and her ability to drive the development and delivery of RIM solutions to enable successful regulatory submissions.

 

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CALYX-20-Headshots-DarrenOaks-FINAL

Manager, Regulatory Implementation

Darren Oakes, PhD

Darren has 25 years in the pharmaceutical industry with experience, knowledge and expertise gained within Regulatory Information Management, Regulatory Affairs, Compliance and Quality Assurance. He currently provides regulatory and consulting services for the implementation and operational use of the Calyx Regulatory Information Management (RIM) system, specializing in EU procedures, XEVMPD, IDMP and Combination Products. Customer focused, Darren supports clients to optimise their use of the RIM system and provides “fit for purpose” solutions to the client’s constantly evolving requirements.

 

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CALYX-20-Headshots-PicardS-FINAL

Senior Project Manager & Data Migration Lead

Stephan Picard, PhD

For more than 15 years, Stephan has managed numerous Regulatory Information Management (RIM) projects and complex data migrations. With both technical and business expertise, he has assisted numerous clients with XEVMPD and IDMP implementations, also working with Calyx RIM Product Management as a subject matter expert.
CALYX-20-Headshots-JuliaMufel-FINAL

Business Analyst, RIM Product Management

Julia Mufel

As a RIM Product Owner, Julia works closely with Calyx’s Engineering and Regulatory Consultants teams to implement IDMP features within Calyx RIM, leveraging her extensive Article 57 experience capturing data and managing XEVMPD submissions. Her expertise includes Registration Planning & Tracking and Product Detail Management, with a focus on XEVMPD and IDMP.

 

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Arrange a meeting with a Calyx Regulatory Consultant today.

SCHEDULE TODAY
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