write from scratch Guidelines for Pre-Approval Activities in Pharmaceutical industry

Pre-Approval Activities Guidelines for Law Firm Organizations in the Pharmaceutical Industry

Introduction

Regulatory Framework

Definitions

Pre-Approval Activities

Internal Approval Process

Review and Approval of Pre-Approval Activities

Conflict of Interest Management

Compliance with Laws and Regulations

Record-Keeping and Documentation

Concluding Remarks

Appendices

Related Checklists