• Protocol design

• CRF design

• CRO selection and management

• Complete project management of NDA, from IND thru product

    launch and Phase IV

• Fiscal management across projects, including budget projections

      and impact assessments

• Informed consent: creation and reviews

• IND, NDA, MAA, 505b2 submissions

• Safety reporting and assessments for both SAEs and ongoing AEs

    from clinical trials

• Data Management

• Design of clinical packaging

• Review of manufacturing procedures and transfer of technology

• Auditing of facilities for regulatory approval

• Communications and face-to-face interaction with FDA and

    European regulators

• Preparation for regulatory audits of sites, and onsite assistance

    during audit

• Management of large groups of professionals, both in-house and

    worldwide

• Due Diligence

• Clinical and regulatory assistance, worldwide