Expert Guidance for Pharmaceutical Containment, Delivery Systems and Combination Products

Reduce Risk before it becomes Rework

Pharmaceutical containment and primary packaging decisions affect product manufacturing, quality, device performance, container-closure integrity, usability, and regulatory readiness. When those decisions are made in isolation—or testing is introduced too late—development teams can face method changes, repeat studies, submission questions, and delays.

DDL brings packaging, containment and delivery systems, analytical testing, and combination-product expertise together to help your team define development phase appropriate testing and to support the next development milestone. Programs are tailored to the product, phase, delivery platform, risk profile, and internal resources of each program.

Pharmaceutical Consulting Services include:

• Combination Product, Containment and Delivery System Strategy
• Analytical and Phase Appropriate Test Strategy
• Performance and Design Verification Strategy
• Stability, Shelf-Life and Distribution Strategy
• Program Review, Troubleshooting and Lifecycle Support with Gap Assessment and Remediation Support All Along the Way

Expert Pharmaceutical Consulting

DDL’s pharmaceutical consulting services are led by Jennifer Riter, an industry leader that brings three decades of experience across pharmaceutical primary containment, drug-delivery systems, analytical services, and combination-product development. Before joining DDL, she held senior global leadership roles where she built and led analytical and development organizations serving injectable, nasal and inhalation.

Her experience includes organizing a global team of more than 200 scientists, engineers, and support professionals across five geographies, leading multiple service-business P&L centers and developing global laboratories and analytical strategies.  Jen has also successfully launched new analytical and development service platforms by integrating packaging, device, testing and commercial into unified work streams.

Under Jennifer’s leadership, DDL’s pharmaceutical packaging consulting will focus on a practical objective: help teams make better technical decisions earlier, build evidence that fits regulatory expectations, and move programs forward with clarity.

FAQs

When should pharmaceutical packaging consulting begin?

Early engagement is ideal—before component, container, or delivery-system choices become difficult to change. DDL can also support programs already in development, approaching verification or validation, preparing for commercialization, or addressing post-market changes and investigations.

What product configurations can DDL support?

Consulting can support primary packaging and drug-delivery configurations such as prefilled syringes, cartridges and pens, on-body delivery systems, transfer systems, and other combination-product platforms. The scope is tailored to the product, delivery route, development phase, and specific technical questions.

Can DDL help us determine which studies are needed?

Yes. DDL can help map product requirements and risks to applicable standards, study types, methods, time points, and decision criteria. The objective is a defensible, phase-appropriate strategy—not a generic list of tests.

Can DDL perform the testing after developing the strategy?

Yes. Depending on the scope, DDL can support laboratory execution through its GMP, FDA registered and ISO/IEC 17025-accredited capabilities and can help coordinate specialized services when needed. This integrated model can reduce handoffs and preserve program context.

Does DDL offer project-based and ongoing consulting support?

Yes. Engagements can be structured around a defined deliverable, a program phase, a technical workshop, or ongoing advisory support based on the customer’s needs and available internal resources

Whether you are selecting a container system, defining an analytical strategy, preparing for design verification, establishing shelf life, or resolving a late-stage challenge, DDL can help you build a focused plan and connect it to the testing needed to move forward.

Contact us for more information or to talk to an engineer.