Prepare and submit the following regulatory documents:

• Complete Investigational New Drug Application (IND)

• IND Amendments and Annual Reports

• New Drug Application (CTD and eCTD format)

• Supplements to an NDAs/ANDAs

• Annual Reports

• Prior Approval Supplements

• Changes Being Effected (0 and 30 days)

• Medical device registration

Orchestrate meetings

• pre-IND

• End-of-Phase 2

• pre-NDA

• mid-NDA

• Guidance meetings

Official spokesperson for all regulatory interactions, communications and questions

Management of user fees and other payments

Prepare responses to questions and warning letters  

Preclinical Development

• Design and implement preclinical programs to support clinical safety and regulatory requirements.

• IND enabling studies

• Studies to support Phase I, II and II clinical studies

• Preclinical Development Plan

Clinical Activities

• Clinical protocol preparation

• Case report forms

• Informed consent forms

• Perform qualification, initiation, monitoring and closeout visits

• Arrange for drug supply packaging, labeling and distribution

• Identify study sites and manage investigator payments

• Preparation of Trial Master Files (investigator site files)

• Prepare clinical sites for FDA inspection

• Organize and manage Scientific Advisory Boards (SABs)

• Safety Reporting

• Monitoring and reporting of adverse events

• Organize and manage Data and Safety Monitoring Boards (DSMBs) 

• Perform GMP and GLP site audits

• Perform pre-approval inspection audits

• Preparation of Standard Operating Procedures

• Perform Quality Assurance audits

• Perform pre-inspection GMP audits

• Prepare companies for regulatory audits

Regulatory Due Diligence

Regulatory Training

Preparation of Regulatory Development Plans