Integrated Guidance to Help You Successfully Bring Your Product to Market
Integrated Guidance to Help You Successfully Bring Your Product to Market
Our Regulatory experts prepare you for interactions with regulators in the European Union and United States across all stages of drug or medical device/IVD development. We provide support on writing/drafting a regulatory strategy and gap analysis, review of clinical trial protocol for regulatory compliance, accelerated development programs such as the FDA’s Breakthrough Therapy Designation and Breakthrough Device Designation and EMA’s PRIME for priority medicines, company core data sheet, label design, investigational new drug application/clinical trial application, biologics license application/new drug application/marketing authorization application, and preparation for the regulatory submissions for FDA device clearance/European conformity CE marking.
Our Medical Strategy team brings deep expertise to provide guidance every step of the way to ensure that your plan is ready for every contingency and opportunity.
Our Biostatistics team contributes unmatched statistical expertise to optimize sample sizes, time to decision, and/or de-risk studies using innovative trial designs, such as Adaptive and Bayesian.
Our Clinical Operations team takes a cross-functional approach to meet global regulatory requirements and complex endpoints through traditional and innovative study designs.
Our Patient Engagement team partners with patients along the product development cycle thanks to patient advisory boards, patient support groups, and patient mobilization programs for clinical trials.
A global medtech company needed help to address FDA feedback on their implant design that included a comparator and clearly demonstrated the safety and performance of this new device.
Our pharma client sought support to evaluate and leverage the data generated from a US trial in other markets and develop a mitigation plan for gaps in evidence.
