Customer Requirement
An India-based pharmaceutical company specializing in generic products required Structured Product Labeling (SPL) to support its US FDA generic drug submission. SPL is a mandatory requirement enforced by the US FDA to ensure standardized labelling, regulatory compliance, and patient safety, applicable during both initial submission and post-approval lifecycle management.
Given the critical role of SPL in ANDA acceptance, any deficiencies in structure, validation, or compliance could lead to submission delays or regulatory objections. The client required an experienced regulatory partner to ensure the SPL met FDA expectations and supported timely approval.
Problem Statement
The client faced several challenges commonly associated with SPL readiness for US FDA submissions:
- Lack of prior experience with US FDA SPL regulatory expectations
- Limited understanding of validation and lifecycle requirements associated with SPL
- Risk of delays impacting overall ANDA timelines due to non-compliant labelling
- Absence of internal expertise to manage SPL obligations post-submission
Without expert regulatory oversight, the client risked regulatory non-compliance, delayed approvals, and disruption to market entry plans.
Key Objective
To develop a US FDA compliant Structured Product Labeling (SPL) file (.xml) that meets regulatory and safety requirements and supports timely submission and lifecycle compliance for a generic drug application.
DDReg Solutions & Processes Adopted
DDReg provided specialized regulatory support and oversight focused on SPL compliance and submission readiness. The engagement emphasized:
- Alignment with current US FDA SPL standards and labelling expectations
- Ensuring regulatory acceptability and lifecycle preparedness
- Supporting submission timelines while maintaining compliance integrity
The approach ensured the SPL was fit for regulatory submission without exposing proprietary processes or internal methodologies.
Business Impact
By partnering with DDReg:
- The client successfully met US FDA SPL compliance requirements
- SPL acceptance supported a smooth ANDA submission process
- Regulatory risks associated with labelling deficiencies were minimized
- The client gained confidence in managing SPL obligations for future submissions
The successful engagement led to continued collaboration on subsequent SPL requirements, establishing a long-term regulatory partnership.
Key Learning
Early engagement with SPL expertise and a strong understanding of regulatory expectations are critical to avoiding submission delays. Strategic oversight and compliance-focused execution enable efficient approvals and sustainable labelling lifecycle management for US FDA submissions.
DDReg delivers US FDA-compliant Structured Product Labeling (SPL) services for generic drug submissions, ensuring accuracy, validation, and regulatory acceptance.
Our expertise supports both ANDA submission readiness and post-approval SPL lifecycle management without compliance risk
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