Post-Approval
Providing efficient, cost-effective solutions to meet your specific Lifecycle Maintenance requirements
Post-Approval
Providing efficient, cost-effective solutions to meet your specific Lifecycle Maintenance requirements
Cost-effective solutions to maintain your established product portfolios
G&L offers a suite of outsourcing solutions and models to ensure your post-approval portfolios are maintained in a manner that is optimized for operational and cost efficiencies. This enables you to focus your internal resource on key, revenue-generating activities.
License maintenance
From staff augmentation to full/part portfolio outsourcing, G&L manages all aspects of post-approval maintenance with quality, cost-effective solutions that ensure your approved products are compliant, maintained, or enhanced.
Services include:
- Variations, supplements and amendments
- CBE-0, CBE-30, PAS, renewals
- EU and global variations
- DSURs and PSURS
- Annual reports and renewals
- Post-approval commitments
- ROW submissions
- Labeling updates
- Marketing and advertising
- Review and submission
Portfolio growth
G&L helps you capitalize on your product’s success by opening it up to new markets, indications, and routes of administration. We provide the strategic and regulatory support needed to expand your product’s reach.
Services include:
- New formulations/redevelopment
- New indication applications
- New packaging configurations
- New market rollouts
- Line extensions
Experience you can trust
0k
30k
CTD sections authored
0k
10k
Variations, supplements and amendments
0+
250+
New market rollouts
Case study
CMC strategy authoring & eCTD publishing outsourcing
"By outsourcing critical eCTD publishing functions to G&L, this company achieved its goal of improving regulatory efficiency"
