We’re here to support your technical and regulatory needs.
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 are here to help in all aspects of your regulatory and product development needs.
Specializing in negotiations with FDA for product development plans and product approval, regulatory strategy for complex issues in drug development and life-cycle management.
FDA Regulatory Compliance
Reliable expert guidance throughout the Molecule to Market process.
FDA-CDER Regulatory Development Specialties
Deep knowledge of product development & FDA approval process.
Animal Health Services (FDA-CVM)
Maximize support & reduce the time to market with our experienced professionals.
Electronic Submission Services (eCTD & eSubmitter)
Submission, conversions or simple maintenance.
From Formulation to FDA Filing
We take a “hands-on” approach to consult with resources that are not only knowledgeable but also willing and able to quickly execute and implement the strategic recommendations suggested.