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Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the first of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
At West, we’re committed to helping our customers navigate the dynamic and ever-changing regulatory landscape. For customers developing combination products, this landscape can be especially complex and challenging.We heard this recurring theme recently when we invited customers to attend workshops — focused on defining strategies for combination products — at a West-sponsored PDA event in Exton, PA, and West’s Combination Product Seminar in Scottsdale, AZ. As part of these conferences, we conducted “voice of customer” surveys to learn more about the key challenges pharmaceutical and device developers face every day.
Regulatory Challenges Top the List
Not surprisingly, the evolving regulatory landscape topped the list of challenges in the survey. Since the final rule on current good manufacturing practice (cGMP) requirements for combination products (21 CFR Part 4) was issued in January 2013, there have been many draft guidances and other regulations introduced. Staying abreast of these changes and managing how to respond to them is a significant hurdle for many of our customers. In addition, the three regulatory challenges described below were noted consistently in our survey results:
Simplify the Journey™
Luckily, West can help drug manufacturers navigate the entire journey as they research, design and deliver a combination product. Our Integrated Solutions program brings together West’s primary packaging, device, analytical testing, regulatory guidance and contract manufacturing expertise in a single-source solution.
If you are interested in some background, the current guidance’s and many draft documents that convey the latest thinking related to combination products, you can find links to many of these documents on the West Knowledge Center.
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.