IGAVIA SCIENCE is a full-service FDA consulting firm that provides an all-inclusive medical device regulatory service offering. Our consulting capabilities include all regulatory and compliance aspects of device and combination product development. We have experience with medical devices across all classes spanning a diverse range of indications, and IVD, OTC & Cosmetics products.

Our goal is to provide clients with unsurpassed scientific knowledge in the areas of FDA regulatory affairs, global regulatory affairs and FDA compliance, to help them achieve their business goals. Our strong corporate values ​​and principles have guided our consultants and clients towards achieving the highest levels of success.

We are highly qualified to assist you during all phases of product development, through the approval process, and with post-marketing requirements. 

Igavia Science consultants are experienced in the use of multiple systems. This speeds up the onboarding process, so our consultants can hit the ground running.

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– Regulatory support and lifecycle management
– Complete up-dated Dossier
– Follow up of registration/notification process

We pay particular attention to personality and core values, to guarantee a good cultural fit with your existing team. Throughout the project, our consultants are continually overseen to ensure we are exceeding your expectations. A Project Lead will maintain contact with you, to make sure you are completely happy with performance, and address any issues that may arise. An Account Manager is also allocated to each Client to ensure ease and consistency of contact, hold regular meetings, and preempt any resource requirements you might have.

Our highly-experienced, multidisciplinary background allows us to react responsively—even at short notice—to quickly match staff to Client needs in both niche and mainstream sectors.

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BACKGROUND

iGavia Science has its beginnings in the Science Sector in cooperation with the industry knowledge and the strategic vision.

Since then, iG. Science has experienced rapid growth, expanding into every major geography to become an admired scientific & regulatory consulting organization.

– Regulatory support and lifecycle management
– Complete up-dated Dossier
– Follow up of registration/notification process

We pay particular attention to personality and core values, to guarantee a good cultural fit with your existing team. Throughout the project, our consultants are continually overseen to ensure we are exceeding your expectations. A Project Lead will maintain contact with you, to make sure you are completely happy with performance, and address any issues that may arise. An Account Manager is also allocated to each Client to ensure ease and consistency of contact, hold regular meetings, and preempt any resource requirements you might have.

Our highly-experienced, multidisciplinary background allows us to react responsively—even at short notice—to quickly match staff to Client needs in both niche and mainstream sectors.

---

BACKGROUND

iGavia Science has its beginnings in the Science Sector in cooperation with the industry knowledge and the strategic vision.

Since then, iG. Science has experienced rapid growth, expanding into every major geography to become an admired scientific & regulatory consulting organization.