Regulatory Affairs Consulting

Don’t risk losing quality and trust: choose the right regulatory guidance, training and support.

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Pharma and API Regulatory Affairs support​

Medical Device Regulatory Affairs support

EU MDR & IVDR Consulting​

Regulatory support to any Medical Device or IVD businesses looking to launch on the European market, needing guidance with CE Markings or wanting to ensure business continuity and renewal.

FDA 510(k) Consulting​

From establishment registration, 510(k) preparation and submission, quality system implementation, inspection support, design controls, and supplier evaluation, to process validation.

Regulatory Intelligence

To successfully comply with regulatory requirements and avoid penalties, rejection and delays, Life Science businesses need to be aware of the challenges posed by different laws operating in different market regions.​​

We can provide regular updates, to make you aware of regulatory requirements applicable to your portfolio, and insights on the expectations of the regulatory authorities.

All in your first language.

Get in touch.

To easily navigate the increasingly complex regulatory market and sell your products in EU, US and Canada, LATAM, MENA, CIS, Africa and APAC.