The Pharmaceutical and Life Science industry requires strict adherence to a variety of layers of paperwork and review. Outsourcing some of this load to a business that specializes in OPDP regulations and other coordinator services can make your job much easier. It can also be instrumental in helping your organization remain in compliance.
When deciding to outsource your firm’s documentation needs you want a company that has a deep understanding of the process and is established and well-regarded in the industry. You want someone who can work on all major technology platforms and provide the kinds of solutions you need to save money and work more efficiently.
Services Provided
Coordinator services are a popular choice for outsourcing. A coordinator will act as a guide through the stages of review and approval required from your organization. An established coordinating service will partner with a range of resources, including project owners, agencies, and reviewers. This ensures that the project remains in compliance, helps identify potential bottlenecks, pinpoints process gaps and keeps the entire project moving forward on time.
Another service to consider is OPDP submission services. Outsourcing the OPDP regulations process ensures that your organization meets end goals by keeping a strict timeline of accurate submissions. This increases the odds of successful review and approval. Project managers in charge of OPDP submission services are experienced in all areas of metadata and comfortable working on various technology platforms. This experience makes it easier for them to put together an accurate Form 2253. Ideally, your consultant will partner with internal regulatory teams and other stakeholders to ensure the best presentation possible for your submission.
What to Look For
If you are ready to outsource some of your filings, consider an established firm such as Framework Solutions, Inc. We can handle everything from compiling the digital file, including any related materials and references, preparing bookmarked CD’s and compiling pre-clearance binders. We also handle Form 2253 preparation so that it is ready for regulatory signature, will package and ship the submission to the OPDP, and handle the archival work in the review platform.