Services

Services

Offered Services

Regulatory Affairs

Correspondence, change management, technical writing and more.

Clinical Writing

Development of CEPs and CERs in accordance with MDR requirements.

Clinical Trials

Clinical trial operations, regulatory approvals and administration.

Strategic Advice

Development of labelling, regulatory and clinical strategy in alignment with commercial goals.

Labelling and Promotional Material

Quality reviews, strategic planning and improvements.

Project Management

Overarching project management in regulatory and clinical development environment.

Want to Know More? Get in Touch

Understanding that your needs in the regulatory and clinical area are highly specific to your organisation’s R&D environment, many projects benefit from a tailored approach. Contact me to find out how I can best accommodate for the services you require and to discuss pricing possibilities.

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How I Work

Identifying What’s Right for Your Project

Understanding Your Needs

Distilling to the fundamental requirements of your current project.

Transparent Communication

Alignment of the skills and breadth of support you require with experience and availability. Identify overlap and gaps to set smart and strategic partnership goals.

Value in Expanding Experience

It’s not all about what I can offer to you – your project always has something to offer to me, too. Let’s find the win/win scenario.

Positive Collaboration

By communicating authentically and bringing enthusiasm, the goal is to experience positivity from the collaboration on both ends.

Referrals

What Others Think

FAQ

Some Common Questions

In case of any questions do not hesitate to e-mail or leave your contact details so I can follow-up at the earliest possibility.

When Can I Expect a Reply?

I aim to get back to your request via e-mail or phone within a business day.

Where Are You Located?

I work remotely from the EU but am flexible to travel worldwide to client sites for in person meetings, extended stays or the entire duration of the project.

What Are Your Terms and Conditions?

The General Terms and Conditions can be found via this link.