Comprehensive Regulatory Operations for 70+ ANDAs/NDAs Enabled Business Continuity for a US based Pharma Company.

A US pharmaceutical company, with a lean Regulatory CMC team and high attrition, struggled to manage over 70 ANDAs/NDAs. Freyr became an end-to-end Regulatory partner, stabilizing operations, filling critical roles, and maintaining compliance.

Client Overview
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Client Overview

The client is a US based pharmaceutical company with a diverse portfolio of over 70 products across multiple therapeutic areas and dosage forms. After four (4) years of association with Freyr, the client sought deeper, long term support to sustain Regulatory workload across its ANDAs/NDAs.

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Client Background

The company had grown its portfolio rapidly but lacked sufficient in house Regulatory CMC capacity to manage ongoing submissions and lifecycle events. High attrition further weakened internal expertise, putting the continuity of filings, responses, and maintenance activities at risk.

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Services in Scope

End to end Regulatory operations for 70+ ANDAs/NDAs, including submissions and lifecycle management.

Registration support for US submissions and related products.

Resourcing and staffing for key Regulatory roles across on site and offshore teams.

Strategic Regulatory guidance and planning for ongoing portfolio management.

Challenge
Challenge

Challenges

Challenge

Limited in house Regulatory CMC resources due to high attrition.

Challenge

Lack of internal expertise to manage complex, end to end Regulatory services across a large portfolio.

Challenge

Inability to effectively handle lifecycle management (LCM) for 70+ ANDAs/NDAs with existing staffing levels.

Challenge

Solution

Freyr implemented a blended on site/offshore Regulatory operations model that combined strategic oversight with hands on document and submission management. Dedicated experts and buffer resources were aligned with the client’s time zones to absorb routine work, ad hoc requests, and strategic activities without disrupting timelines.

 

1
Challenge

Deployed dedicated on site Regulatory experts working alongside client teams, supported by offshore Regulatory specialists aligned to US time zones.

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Challenge

Added buffer resources to manage peaks in workload, ad hoc activities, and urgent requests without compromising quality.

3
Challenge

Assigned Regulatory associates for ANDA/NDA/BLA submissions and lifecycle management, including registration and maintenance requirements.

4
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Took ownership of strategic Regulatory guidance and operational execution, standardizing processes and documentation across 70+ products.

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Impact

Challenge
  • Ensured seamless business continuity for a complex portfolio of 70+ ANDAs/NDAs.
Challenge
  • Reduced overhead for the client by adopting a flexible, expert driven staffing model.
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  • Maintained registration requirements for all in scope products with consistent, compliant Regulatory operations.

 

Freyr became an integrated Regulatory partner, turning a resource-strained team into a scalable, stable operation. The client gained predictable support, improved submission control, and agility for new portfolio additions. This positioned the company to grow without risking compliance or timelines.