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Regulatory: Pharma

eCTD Software Platform for eCTD Submissions

Our services: software support

As part of our regulatory services in pharma, the Alira Health team can publish documents, validate, and compile submissions and submit them via electronic submissions gateway to the FDA.

Why choose Alira Health?

As your partner, Alira Health supports your innovation, optimizing product development success every step of the way. Our integrated, collaborative teams provide a lifecycle approach to delivering our services, including:

Regulatory strategy
Regulatory intelligence
Regulatory operations
Clinical
Market access

Explore Regulatory Pharma Services:

Regulatory Strategy and Due Diligence

FDA Meeting Preparation and Representation

FDA Applications Preparation, Management, and Submissions

CMC, Non-clinical, Clinical, and PK Program Support

Assistance with Accelerated Review Programs

CMC Quality and Regulatory Affairs

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