Drug Development Regulatory Affairs

Navigating Drug Development with Expert Regulatory Guidance – Guiding You Through Every Stage from Clinical Trials to Market Approval

At PCI Portal, we provide expert regulatory guidance throughout the drug development process, ensuring that your products meet all regulatory requirements and achieve market approval.

a. Management of Clinical Trials
We oversee the clinical trial process from start to finish, ensuring compliance with regulatory standards and providing the necessary support to achieve successful outcomes.

b. Investigational Drug Application
Our team prepares and submits Investigational Drug Applications (IDAs), ensuring that your clinical trials are approved and conducted in accordance with regulatory requirements.

c. New Drug Application
We provide comprehensive support for New Drug Applications (NDAs), guiding you through the regulatory process to secure approval for your new drugs.

d. Discussions and Meetings with Regulatory Authorities
We facilitate discussions and meetings with regulatory authorities, including requesting Type A, B, and C meetings, to address any regulatory issues and ensure a smooth approval process.

e. Chemistry, Manufacturing, Controls (CMC) Regulatory Support
Our CMC regulatory support services cover all aspects of chemistry, manufacturing, and controls, ensuring that your drug products meet the highest quality standards and regulatory requirements.