Pre-launch services help prepare your product for FDA approval through clinical trial transition assistance, market research, patient registry development, launch planning, sales force support and education and expanded access programs.
Lash Group’s URAC-accredited clinical services provide solutions for pharmacovigilance and regulatory compliance, including FDA requirements, such as REMS.
Our call center services eliminate the need to tie up in-house resources, providing information and updates to patients, pharmacists and prescribers alike to help you meet FDA requirements around pharmacovigilance, regulatory compliance and medical information services. Our scalable services allow you to take advantage of all we have to offer throughout your product’s lifecycle, from introducing new delivery systems to a change in packaging or any other program enhancements required. Additionally, our pharmacovigilance service meticulously compiles adverse event information in an FDA-ready report.
Lash Group has experience planning, designing and implementing REMS programs. Our validated software delivers on a wide range of features such as training, registry and tracking, to support the needs of your product.
Partnering with Xcenda, part of AmerisourceBergen, we help you develop your REMS strategy and then assign an implementation team to work closely with you throughout the design and implementation phases. We build and administer the tools and systems necessary to ensure full compliance with FDA regulations.
Our marketing support includes communications deliverables such as collateral, sales force training, web-based seminars, trade show support and marketing fulfillment.