Case Studies and Testimonials

Partners.  Colleagues.  An extension of your project team.  These are just a handful of the things we strive to become with each of our clients, regardless of the size of the company or the complexity of the project.

But don’t just take it from us – have a look at some recent case studies to see the types of projects we get involved with and what our clients have to say about us.

Case Study #1: The Journey Leading to an Approved NDA

See the expert services we offered and the long-standing relationship we developed with one client as we provided medical writing, project management, and regulatory consulting services, beginning with CSR authoring all the way through 2 NDAs, 2 FDA Advisory Committee meetings, and an eventual NDA approval.

Case Study #2: From the Bench to the Clinic

Click to read more about how we have worked closely with a University-based team as we have managed all activities of their development program beginning with nonclinical testing and CMC activities through clearance of the IND and the successful completion of their first-time-in-human clinical trial.

Case Study #3: Establishment of a Long-Term Medical Writing Partnership

By consistently providing high-quality medical writing services for this mid-size global client, a relationship based on trust was developed, resulting in the establishment of a formal Strategic Alliance Partnership with the client, an opportunity that allows us to write a large number of their CSRs each year.

Case Study #4: Expert Regulatory Affairs Services for a European-Based Client

See how we have helped this UK-based client establish and manage a multi-disciplinary team that was responsible for a successful Pre-IND meeting and an IND that was ultimately cleared by FDA, thereby allowing for the initiation of a Phase 2 study in the US for a new chemical entity.

Case Study #5: Successful US/EU Marketing Applications for Big Pharma

Click to read about how we expertly authored numerous CSRs and various components of an NDA and MAA that we also adeptly managed under very tight timelines – both applications were ultimately approved.

Case Study #6: Regulatory Affairs Strategy and Project Team Lead

Click here to see how IMPACT has been providing high-level regulatory affairs support across multiple development programs for a mid-size pharmaceutical company since 2009.

Case Study #7: Regulatory Operations Department Developed and Flourishing

Click here to learn how/why IMPACT’s Regulatory Operations department was started and the immediate successes garnered by the department.