In fast-moving markets where execution is crucial, there is no substitute for experience, and our organization brings a range that’s broad and deep.
LEADERSHIP TEAM
Our leadership team has worked together for more than 20 years and draws on extensive backgrounds with senior management experience in medical and drug information, medical communications, product lifecycle management, regulatory affairs, and pharmaceutical marketing – with both branded and generic products – so we bring extraordinary insight and astute perspective to our role in the success of your products
Carole DeRoche, MA, MT(ASCP)
PresidentPharmaceutical experience
- 20+ years
- Branded and generic products
Donna Multhauf, BS, MBA
Director, Regulatory AffairsPharmaceutical experience
- 25+ years
- Branded and generic products
MEDICAL AFFAIRS STAFF
Medical advisors with more than 10 years of post-marketing safety experience form the backbone of the group. Our healthcare professionals include individuals with BSN and PharmD degrees in addition to retail pharmacy, clinical nursing, and drug information backgrounds. We offer extensive experience in providing consumers, patients, and healthcare providers with product usage directions, as well as in responding to complex questions involving product information.
REGULATORY AFFAIRS STAFF
We provide more than 30 years of collective experience in post-approval issues including preparation and submission of annual reports and submission of periodic and expedited AE reports. Our experience also includes labeling content revision, manufacturing changes and related submissions for NDAs and ANDAs.
