Regulatory  Documentation

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)

FDA Briefing Documents

Target Product Profile

Special Protocol Assessments

Package Inserts

CTA’s in Canada and Europe

Preparation of Drug Master Files

Orphan drug designations

Pediatric Proposals and Waivers 

Interaction with Food and Drug Administration

Orchestrate meetings with FDA

pre-IND

End-of-Phase 2

pre-NDA

mid-NDA

Guidance meetings

Official spokesperson for all FDA interactions, communications and questions

Management of user fees and otherpayments to FDA

US Agent for Drug Master Files

Prepare responses to FDA questions and warning letters  

Other

Regulatory Due Diligence

Regulatory Training

Preparation of Regulatory Development Plans

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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 Development & Research

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

Safety Reporting

Monitoring and reporting of adverse events

Organize and manage Data and Safety Monitoring Boards (DSMBs) 

Quality

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