Missed our recent webinar for Emerging Pharma?
You can now access it on-demand. Our panel of experts will provide you with a roadmap for bridging the packaging gap between late stage 2 clinicals and commercial supply.
The Life Science supply chain and regulatory environment is complex.
When developing and launching a product, it's critical that you have access to an experienced, multidisciplinary team with deep sectoral knowledge who can deliver in line with your commercial expectations and more importantly who can mitigate the risk of project failure is critical. Building this team and bringing it in-house can be time-consuming and a serious drain on resources.
Outsourcing can remove the challenges of setting up and managing multiple internal departments
and help you get your product to market faster,more efficiently and more cost-effectively.
Late Stage Phase 2
The Journey Begins
This is where our expertise takes hold and where we can help you to “bridge the gap” and start to lead the journey to ultimate product commercialization.
Phase 3 Registration Stability Production
Registration and Submission
Do you know what it takes, for example…
- To ensure proper scale of packaging operation to meet commercial demand?
- To develop effective and compliant packaging branding?
- To successfully develop compliant labeling content and build artwork that is fit for regulatory submission?
- To submit your dossier to a regulatory authority in any market?
How we help:
- Strategic Outsourcing BPS
- E2E Technical Project management
- Artwork coordination
- Market coordination
- Consultancy
- Oversight of packaging process development
- Launch strategy development
- Risk packaging strategy development
- Label content development (IFU, SmPC, etc.)
- Translation
- Translation Management
- Regulatory support for market access, filing, content management
- Creative & Digital
- Packaging design and guidelines creation
- Packaging & Labeling
- Artwork creation and change implementation on RX and OTC packaging and marketing inserts, PL’s and IFUs.
- Change control management
- Proofreading/verification
- 3D product imagery Wireframe creation
- Dieline/keyline development
- GLAMS Enterprise, Small or Q
- Artwork management system
Things to be considered:
- Packaging process qualifications and validation
- Package testing
- Packaging distribution considerations (e.g., cold-chain..)
- Patient safety-focused, cost-effective design
- Market specific packaging and labeling regulatory requirements
- Fully compliant, submission ready master-artworks
- Ability and authority to act on behalf of your company to make a filing
- Launch strategy and risk mitigation strategy development
Pre-Commercial
Do you know what it takes, for example…
- To meet your patients’ needs and flawlessly execute your launch strategy to deliver “launch excellence”?
- To maintain ongoing regulatory compliance and packaging costs and efficiencies?
How we help:
- Strategic Outsourcing BPS
- E2E Technical Project management
- Artwork coordination
- Market coordination
- Consultancy
- Regulatory support – post-approval changes
- Label implementations strategy and process development
- Packaging efficiency measurement and re-specification
- Creative & Digital
- Ongoing marketing, Training and support for brand / corporate communication materials
- Packaging & Labeling
- Ongoing artwork support
- Change control management
- Proofreading/verification
- 3D product imagery Wireframe creation
- Dieline/keyline development
- GLAMS Enterprise, Small or Q
- Artwork management system
Things to be considered:
- Execution of product launch according to strategy
- Managing and tracking complex and multiple post-approval labeling changes
- Monitoring COGs through Life Cycle and up to peri-LOE
Meet the Leadership Team who can bring you on the journey and help you bring your products to market faster and more efficiently.
Gabriele Iannizzotto
Martina Forristal
Lenny Figorski
Michael Fleming
Sam Cole
