Regulatory Affairs

We can support on your projects all along the lifecycle of the products to ensure compliance withe the regulatory requirements and timely approval in a worldwide range.

Regulatory affairs is the domain that monitors the way food, drugs, cosmetic products, and medical devices are developed, tested, manufactured, marketed and distributed in order to certify that they meet regulatory standards for human and animal use.

Regulatory Affairs plays a crucial role in the health products industry from the early development phases throughout the life cycle of the health products, where they are responsible for ensuring manufacturers’ compliance with applicable laws and regulations as well the safety and efficacy of health products.

We can support your projects all along the lifecycle of the products to ensure compliance with the regulatory requirements and timely approval in a worldwide range. Our team ensure a close partnership to provide a personalised offer in accordance with regulatory requirements and in compliance with your processes.

Our expert teams have over 25 years of regulatory knowledge and experience at a global level to viable strategies and efficient development pathways, thanks to 3 key advantages:

Full industry scope

We are specialised in all facets of pharmaceutical and medical device development and regulation.

FDA, EMA and International

We combine extensive scientific and regulatory experience to achieve successful outcomes with regulators across continents

Full life cycle support

From early-stage development through to approval and marketing, our regulatory affairs consultants support our clients to meet regulatory needs across the entire life cycle of products

Our sectors

Pharmaceutical

Food

Biotech & Vaccines

Medical devices

Veterinary

Cosmetic

We provide regulatory solutions and assistance throughout the life cycle of drug products, medical devices, cosmetic products and food supplements (pre-MA and post-MA activities). Our teams ensure a close partnership to offer a personalised response in accordance with regulatory requirements and in compliance with your processes.

Merita, regulatory affairs expert

Our delivery methods

Technical assistance
Technical support, advice and expertise

Platform
A range of services dedicated to your activities driven by our team

Projects
Perfomance with commitment to results

Aixial Group around the world

Aixial Group can help you around the world. We provide services onshore, nearshore, and offshore to ensure that your solution is customized to your specific needs.

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