Client Overview
The client is a US based pharmaceutical company with 15 ANDAs/NDAs and pipeline products across multiple therapeutic areas. With no internal Regulatory department, the company required an experienced partner to manage its entire Regulatory operations landscape.
Client Background
As the client advanced more products toward registration, gaps in coordination with CMOs/CROs and a limited understanding of FDA submission requirements threatened the quality and timelines of submissions. The absence of a dedicated Regulatory function created risks for approvals and ongoing compliance.
Services in Scope
Complete Regulatory operations for 15 products, including initial registrations and lifecycle management.
Health authority interaction support with US FDA and other agencies.
Labeling and artwork review and support.
End to end publishing and submission preparation.
Regulatory strategy design for NDA/ANDA and LCM activities.
Challenges
Absence of an in house Regulatory team to own submissions, HA interactions, and lifecycle management.
Limited coordination with CMOs/CROs, causing delays and incomplete document flows.
Insufficient awareness of US FDA expectations and requirements for NDA/ANDA submissions.
Solution
Freyr became the client’s virtual Regulatory department, combining strategic submission planning with hands on dossier preparation, publishing, and agency liaison. A structured coordination framework with CMOs/CROs was established to ensure timely, complete documentation and compliant submissions.
1
Designed Regulatory submission strategies for each product and aligned them with the client’s commercial and development priorities.
2
Established robust coordination mechanisms with CMOs/CROs to ensure the timely flow of high quality documents for submissions.
3
Conducted gap analyses and prepared NDA, ANDA, LCM, and pre submission packages, including labeling and artwork components.
4
Managed end to end publishing, submissions, and HA interactions while supporting expansion into other markets where needed.
Impact
- Achieved zero Regulatory rejections across the supported submissions.
- Ensured continuity of business operations by removing Regulatory burdens from the client’s internal teams.
- Embedded Regulatory best practices into submission and lifecycle processes for all in scope products.
By outsourcing Regulatory operations to Freyr, the client filled capability gaps without building an internal team. The engagement achieved rejection-free submissions and freed resources for R&D and commercial priorities. This model now guides future product launches and market growth.
