Lifecycle Management (Post-Approval)

Ensuring Long-Term Compliance and Product Sustainability

Overview

After a product is approved, the regulatory journey doesn’t end — it evolves.
At North Pharma Consulting, we provide comprehensive post-approval support to help companies maintain compliance, implement changes effectively, and ensure uninterrupted market availability.

Our team manages all variations, renewals, and extensions in accordance with international regulatory frameworks, including EU, UK, CIS, MENA, LATAM, and Asia.
By applying principles of ICH Q12 lifecycle management, we ensure a science- and risk-based approach to post-approval changes.

Key Challenges We Address

  • Complex coordination of variations across multiple authorities
  • Inconsistent documentation and tracking of post-approval changes
  • Insufficient resources for renewal and maintenance activities
  • Lack of clear change control mapping and regulatory risk assessment
  • Delays in product updates due to inefficient variation management

Our Approach

1. Variation & Change Management

We handle all types of post-approval variations — Type IA, IB, and II — including safety updates, manufacturing changes, and formulation modifications.
Our experts ensure correct classification, documentation, and timely submission to prevent compliance gaps.

2. Renewal Applications

We coordinate marketing authorisation renewals and ensure that your product continues to meet updated regulatory requirements.
This includes dossier review, updated Module 1–3 data, and submission of renewal applications within the required timelines.

3. Line Extensions & Grouping/Worksharing

North Pharma Consulting assists in managing line extensions, grouping, and worksharing procedures, ensuring harmonized implementation of changes across markets and minimizing duplication of effort.

4. ICH Q12 Change Control Implementation

We support the design and execution of change control strategies based on ICH Q12 guidelines, helping clients implement post-approval CMC changes efficiently and predictably.

5. Deficiency Response & Documentation Updates

Our team prepares deficiency response templates, manages authority queries, and updates technical documentation (CTD) accordingly to maintain full compliance and traceability.

Benefits

  • Ongoing product compliance across multiple jurisdictions
  • Reduced regulatory risk and approval delays
  • Harmonized lifecycle processes across affiliates
  • Efficient management of post-approval variations and renewals
  • Predictable, science-based change implementation (ICH Q12)

Why Choose North Pharma Consulting

With extensive experience in managing complex global variation portfolios, North Pharma Consulting ensures your product remains compliant, stable, and ready for continuous market supply.
Our experts combine regulatory knowledge with strategic foresight to simplify lifecycle management and reduce administrative burden.