Change Control and Regulatory Impact Assessments

Life Cycle Management

Change control and regulatory impact assessments

Our regulatory experts collaborate closely with cross-functional teams to ensure changes are implemented efficiently with no disruption to market authorization or supply continuity.

Change control and regulatory impact assessments

At Techsol, we offer strategic support for change control and regulatory impact assessments, helping pharmaceutical and biotech companies manage internal changes while ensuring global regulatory compliance.

Whether the change involves manufacturing, packaging, labeling, testing, or supply chain activities, we provide a risk-based evaluation of the regulatory impact and guide the appropriate submission strategy.

Our Services Include:

Our Expertise and Value Proposition

End-to-End Regulatory Insight: We understand the full lifecycle impact of changes and ensure your regulatory decisions are aligned with business needs and HA expectations
Global Experience: Our team handles change assessments and submissions across major markets, ensuring alignment with local and international regulatory frameworks
Risk-Based Approach: We apply ICH Q9 principles and agency guidelines to assess change impact, ensuring a defensible and efficient regulatory strategy
Lifecycle Compliance Management: Techsol helps you maintain product integrity and compliance from development through commercialization even as your operations evolve