Successful Filing of ANDA-General Correspondence, Annual Report, and PADER Submissions

A global pharmaceutical company was looking for Regulatory support in the filing of ANDA General Correspondence, Annual Reports, and PADER submissions. The project presented several challenges, such as:

Tracking versions of frequently changed documents
Maintaining the lifecycles for all the products
Stringent timelines

By providing dedicated support to the client, Freyr was able to accomplish the task with two (02) days left in the deadline and took care of the LCM activities for all the products.

For a detailed understanding of how Freyr's team extended its support to the client in meeting their business requirements and ensuring the successful filing of ANDA General Correspondence, Annual Reports, and PADER submissions with zero errors, download the proven case.

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Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.

Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.

The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.

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