GLEN BURNIE, Md., April 9, 2015 /PRNewswire/ — CSSi LifeSciences™ (www.CSSiLifeSciences.com), a partner company of CSSi (www.CSSiEnroll.com), is the trusted go-to company to provide innovative, fully integrated solutions that span the entire lifecycle of a new drug or device. Jim Sergi, President of CSSi LifeSciences™, is pleased to announce the newest product offering in their portfolio of services – Creation of the Ideal Package Insert.
Creating the Ideal Package Insert (PI) is a highly labor-intensive and collaborative process that requires a thoughtful approach and expertise from industry stakeholders. Companies often view the PI and label as an after-thought with generic nomenclature, and with little consideration of the commercial market, including the pricing and reimbursement authorities.
Our process analyzes the future competitive landscape, and then reverse engineers the PI to optimize the clinical and supportive bridging studies and achieve the target market claims in alignment with the regulatory strategic options. We combine a deep understanding of health authority requirements and help our clients develop a clinical strategy to achieve a PI and label that differentiates the product and drives value through the product lifecycle.
Our experience to help develop the Ideal Package Insert and Label includes:
- Labeling analysis and structures comparisons
- FDS and Notified Body collaboration, negotiation and appeal
- Patient information leaflets
- Readability testing
- Medication guides
- Instructions for use
- Bridging the post market surveillance studies to support claims
About CSSi LifeSciences™
CSSi LifeSciences™ has successfully enabled the development of drugs, biologics, devices and in-vitro diagnostics for its clients. Their unique service positions us to engage with our clients to provide a comprehensive suite of scalable services to develop therapeutic candidates with cost efficient predictability. They have the expertise to support lifecycle strategies to drive product value, extend market share, and maximize the ROI.
About CSSi
CSSi delivers global patient recruitment solutions that ensure successful enrollment, on time, every time. Through its innovative enrollment planning and full-service patient recruitment solutions, CSSi is able to reduce the costs and timelines associated with recruitment of subjects for clinical studies.
For more information on CSSi LifeSciences™, visit www.CSSiLifeSciences.com, and for more information on CSSi, visit www.CSSiEnroll.com or contact Shannon Powell through Email or call 443-308-5809.
Contact:
Shannon Powell
CSSi LifeSciences™
P: 443-308-5809
F: 410-553-0087
Email
www.CSSiLifeSciences.com