Our goal is to improve the technical and regulatory aspects of your operations, so that both our businesses can enjoy growth together.

Specializing in negotiations with FDA for product development plans and product approval, regulatory strategy for complex issues in drug development and life-cycle management

Resources that are not only knowledgeable, but also willing and able to quickly implement the recommendations offered (i.e. “Hands-On Consulting”)

Virtual Company FDA Compliance

FDA’s May 2013 Guidance for Industry on Contract Manufacturing Arrangements for Drugs: FDA will hold a virtual company responsible for having caused the introduction of an adulterated drug into interstate commerce if it…

FDA Regulatory Specialties

Need help filing an application or meeting with FDA? We provide the following services…

eCTD Services

Just need help with electronic submissions? We are dedicated to providing the same outstanding quality of service across all electronic submissions, be it an IND, NDA or ANDA submission, conversion to eCTD format or simply the maintenance…

US Agent Services

The U.S. Agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. Agent cannot use a post office box as an address. The U.S. Agent cannot use just an answering service. They must be available to answer the phone or have

About Us

Pharmobedient Consultants are widely recognized within the pharmaceutical industry for the ability to help companies successfully resolve complex regulatory challenges. Whether it’s preparing for an FDA audit, responding to an FDA audit, filing an IND/NDA/ANDA, or simply putting some SOPs in place — we’re here to help in the most cost effective way possible.