What are Lifecycle Management Services?
Our services include managing post-approval variations, labeling updates, change control, and license renewals, ensuring global regulatory compliance and market maintenance for pharmaceutical products.
Pharmaceutical Lifecycle Management for Global Compliance
Sustain Market Readiness with Expert Support
At Indivirtus Healthcare Services Pvt. Ltd., our Pharmaceutical Lifecycle Management services provide end-to-end support for post-approval variations, labeling updates, change control, and license renewals. We ensure continuous compliance with EMA, FDA, CDSCO, and other global regulatory bodies, keeping your product market-ready.
Why is it Critical?
Effective lifecycle management ensures continuous compliance, minimizes regulatory risks, and maintains market authorization, supporting product longevity and patient safety.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led lifecycle solutions, providing tailored support to navigate global regulatory requirements and sustain market presence.
Our Expert Lifecycle Approach
At Indivirtus Healthcare Services, our Pharmaceutical Lifecycle Management services are led by certified regulatory experts with global compliance expertise. We handle post-approval variations, labeling updates, change control assessments, and license renewals, tailored to meet region-specific requirements.
Our structured approach ensures seamless regulatory compliance, aligning with ICH Q12, EU Regulation (EC) No 1234/2008, US FDA Post-Approval Changes, and CDSCO guidelines to support market maintenance and product lifecycle.
Lifecycle Management Deliverables
Variation Application Dossier: Comprehensive documentation for post-approval changes.
Updated Product Labels and SmPC: Region-specific, compliant labeling updates.
Change Control Impact Assessment: Detailed evaluations for regulatory alignment.
License Renewal Filing Documents: Submission-ready documents for market authorization.
Regulatory Compliance & Global Standards
Our Pharmaceutical Lifecycle Management services align with stringent global standards, ensuring your products are market-ready and compliant with international regulatory expectations. By adhering to industry-leading guidelines, we deliver solutions that enhance regulatory confidence and product longevity.
- ICH Q12: Guidelines for pharmaceutical lifecycle management.
- EU Regulation (EC) No 1234/2008: European standards for post-approval variations.
- US FDA Post-Approval Changes: U.S. regulations for post-market modifications.
- CDSCO Guidelines: Indian standards for pharmaceutical regulatory compliance.
Applications & Use Cases
Our Pharmaceutical Lifecycle Management services are essential for pharmaceutical companies maintaining global market authorization. Ideal for post-approval variations, labeling updates, and license renewals, our solutions support compliance and market presence. Key use cases include managing post-market changes, updating SmPCs for EMA compliance, and renewing licenses with CDSCO.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for pharmaceutical companies, delivering expert-led lifecycle management solutions backed by certified regulatory professionals with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your organization with compliant, efficient lifecycle management, driving regulatory success and sustained market presence.
Frequently Asked Questions
Frequently Asked Questions
What are variation filings in pharmaceutical lifecycle management?
Variation filings are submitted to regulatory authorities to update a marketing authorization following changes in manufacturing, packaging, labeling, or clinical data.
When should labeling updates be filed?
Labeling updates should be filed whenever there are changes in product safety, dosage, indications, or regulatory guidance. These must be reflected in the SmPC and PIL.
How is regulatory change control managed?
We assess the regulatory impact of each internal change and determine whether a variation filing is needed, ensuring proper documentation and compliance.
What is the timeline for license renewals?
Timelines vary by region but license renewals generally need to be initiated 6–12 months before expiry to ensure uninterrupted market authorization.
Can you manage lifecycle filings globally?
Yes, we provide full lifecycle management support across global regulatory jurisdictions including EMA, FDA, CDSCO, MHRA, and more.
What do Pharmaceutical Lifecycle Management services include?
Our services include post-approval variations, labeling updates, change control assessments, and license renewals, tailored for global regulatory compliance.
Who benefits from Pharmaceutical Lifecycle Management services?
Pharmaceutical companies maintaining market authorization or managing post-approval changes benefit from our tailored solutions.
How do these services ensure regulatory compliance?
Our services align with ICH Q12, EU Regulation (EC) No 1234/2008, US FDA Post-Approval Changes, and CDSCO guidelines, ensuring global compliance.
What deliverables are provided with the service?
Clients receive variation application dossiers, updated labels/SmPCs, change control assessments, and license renewal documents.
Can the lifecycle management services be customized for our needs?
Yes, our services are tailored to your specific product, market, and regulatory requirements, ensuring compliant and effective solutions.
How do the services support market maintenance?
We manage variations, labeling updates, and renewals to ensure continuous compliance and sustained market authorization across global regions.