The Client was an IP licensing firm with no prior FDA experience that had just licensed an agro-chemical product that they believed had the potential for use as a human drug.

What was Anson’s solution?

The Anson team developed and implemented a milestone-paced development plan for advancing the compound through Phase 1 clinical trials.  The Anson team guided the compound’s drug development project from planning through the IND filing, needed to begin human clinical trials, in just 22 months.  Anson consultants provided the Client with a wide range of drug development services including project management, clinical study design and planning (including protocol development), case report form (CRF) review, investigational site management and monitoring, and data summary and presentation.  In addition to serving as the liaison with FDA for regulatory issues management and representing the Client at multiple meetings with the Agency, Anson prepared and submitted the NDA for the Client, leading to a successful drug approval.

Using Anson as a trusted regulatory resource can help create new value realization opportunities.

The Client, a large medical device manufacturer that had developed a multi-tiered remote monitoring system, questioned whether the stringent regulatory requirements that applied to its primary, implantable, medical device also applied the remote monitoring system.  Other remote monitoring systems of similar function had been cleared under the 510(k) process, which resulted in much lower regulatory costs and time-to-market.

What was Anson’s solution?

Anson consultants conducted a thorough analysis of the Client’s entire system and developed strategies to isolate and segment portions of the system according to risk and to match appropriate regulatory requirements for each level of risk.  This Anson analysis has served as the Client’s basis for strategies to eliminate unnecessary costs and time that could put the company at a competitive disadvantage in designing future releases of its system.

The Client had developed an innovative new product for detection of a dangerous airborne contaminant affecting emergency first responders.  The Client sought to bundle this diagnostic product with a time-critical treatment from a pharmaceutical manufacturer.  While the Client had no previous experience working with FDA or familiarity with the scope of effort and time necessary to satisfy FDA requirements, the company’s ability to secure public and private funding for further product development made time and costs vitally important to it.

What was Anson’s solution?

Anson conducted a full regulatory assessment of the product, including design, manufacturing, and quality systems requirements.  This regulatory assessment included specific analysis and recommendations on steps the Client should take for regulatory clearance of the new device, such as the device’s likely product classification and predicate devices to which it was most likely comparable.  Anson also identified gaps in design and quality processes that required further development before the Client could complete the necessary regulatory submission and fulfill its obligations as a supplier to its drug company partner.