Quality and Regulatory Expertise: A Clearer Path for Regulated Products
Technical, quality, and regulatory expertise that helps pharmaceutical and biomedical clients plan for packaging success.For pharmaceutical, biomedical, and other life sciences companies, packaging decisions reach into nearly every part of a product’s journey to market. Product stability, testing, manufacturing, filling, documentation, and delivery all influence the outcome. We help our clients understand those connections early so they can make informed decisions about scope, cost, and timing.
That understanding begins with the Sonic Session, the first step in Sonic's broader six-step Sonic Approach.
This detailed, no-obligation discussion focuses on your goals, requirements, ideas and desired outcomes. It gives us a shared foundation for deciding what your project needs and who should be involved.
As projects move forward, Sonic's quality and regulatory specialists help evaluate the technical requirements that can influence development and commercialization.
As an industry-leading contract packaging and product-filling solutions provider, we specialize in single- and multi-use delivery systems. Our clients span diagnostic, pharmaceutical, medical device, nutrition, CBD, beauty, cosmetic and animal health markets. The Sonic Approach consolidates the supply chain into a single point of contact, supporting clients from concept through commercialization and post-project support.
For projects involving FDA requirements, follow-up discussions connect your goals with the technical expertise needed to evaluate the path ahead. Our quality and regulatory specialists help make those considerations part of planning and decision-making early in the process.
Understanding the Product Before Mapping the Work
Our Vice President of Technical Sales, Quality and Regulatory, Susan (Sue) Spillane, brings 23 years of experience with Sonic, including work in packaging technology, operations, R&D, and product development. Her background in biochemistry and biological sciences informs our discussions about regulated products.
Our sales and business development team typically involves quality and regulatory specialists after collecting initial information, often during a second meeting. That follow-up builds on the Sonic Session by exploring questions such as:
- What is your product’s regulatory classification and intended use?
- What development and regulatory work have you already completed?
- Are you developing a new product or planning a technology transfer?
- Where do you need our assistance, and what is your target timeline?
Your answers clarify the starting point. An existing product moving to another facility requires a different plan from one progressing through early development. That distinction shapes the work, responsibilities and expectations for the project.
For pharmaceutical development, the discussion also addresses where your product stands in the FDA process and what manufacturing and testing work has been completed. Those details reveal where our expertise can support your next stage.
Making the Timeline More Realistic
A target launch date needs a plan that accounts for the work required to reach it. In our experience, clients sometimes underestimate the time and cost associated with development, testing and commercialization.
Depending on your project, the path may include lab batches, engineering batches, pilot batches, stability work and submission batches. We map those requirements into a project plan that explains the sequence, time allocated to each step and associated costs.
Analytical testing deserves particular attention. A key decision is whether existing testing methods can be transferred or whether method development is needed. Developing a method can require additional time and expense, making it an important consideration in the schedule.
Earlier engagement gives us more opportunity to identify gaps and coordinate packaging development with testing needs. That can help you reduce avoidable delays and progress toward commercialization with a fuller understanding of quality and regulatory requirements.
Selecting Packaging That Supports Product Performance
Your product's intended performance guides packaging selection. Throughout the evaluation process, desired shelf life, stability, delivery, and customer use help shape our recommendations for the appropriate structure.
A critical part of that evaluation is understanding the barrier properties your package must provide. The technical review considers moisture vapor and oxygen transmission rates against stability and shelf-life requirements. We also look at how your end customer will receive and use the product.
The evaluation continues through shipment. If your product requires refrigeration during transport, for example, those requirements become part of the overall plan. Looking from the initial lab batch through delivery helps us identify critical attributes and the work needed to support them.
For you, this creates a clearer connection between packaging choices, product requirements, and the experience of the person ultimately using your product.
Finding Opportunity in a Technology Transfer
When taking on a technology transfer, we start by understanding how your product has been made and packaged previously. Existing documentation provides the foundation for evaluating the process at the receiving facility.
That assessment covers manufacturing and filling equipment, including blending vessels, pumps, hoses, clamps, and packaging systems. Missing documentation can affect cost and lead time, making early access to your records and subject matter experts essential.
A detailed review can also uncover opportunities for improvement.
Sue recalls one transfer in which our team identified changes to the client’s previous processes and filling systems. Improvements became part of the engineering, pilot, and stability work. The result was approximately 10% better yield than at the previous plant.
Our client gained more product for the marketplace somewhat faster and eventually received a slight price rebate. That experience demonstrates how a detailed technical review can create commercial value alongside the work of transferring production.
Keeping You Informed and Involved
Quality and regulatory oversight continues throughout project execution. Regular client calls, shared documentation platforms, an overall timeline, and a project action plan keep participants aligned.
Documentation checklists cover requirements such as packaging specifications and client approvals. These records help us track required information and sign-offs as your project progresses, keeping important details visible throughout the work.
When new information or an unexpected issue emerges, you hear from us promptly. Together, we review the information, consider a course of action, and discuss how your project plan may be affected.
Direct communication between both organizations’ subject matter experts supports that process. Our specialists, your team, and the plant can work through technical questions, document revisions, and requirements together. Your team stays involved in decisions that influence the product and schedule.
A Partnership Built Around Your Needs
Our approach places quality and regulatory expertise at the center of development from the start.
"Quality and regulatory is not a supporting role. It’s a key function that’s required to launch a commercially successful product,” Sue explains.
That principle shapes our partnership with you. A close working relationship depends on understanding your quality systems, approval processes, artwork requirements, project management, and commercial needs, along with the product itself.
Clients have described us as an extension of their company. Close collaboration and a clear understanding of their needs help earn that relationship throughout the project. The goal is an experience that feels straightforward and well coordinated.
Quality and regulatory expertise strengthens that relationship by helping bring the right people, questions, and requirements into focus as the project moves forward. Together, we create the understanding that guides your Sonic Path to Packaging Success.