We’re here to support your technical and regulatory needs.

About

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.

Services

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.

Contact

7 + 8 =

COMPANY

Strategy for complex issues in drug development and life-cycle management.

CONTACT

642 NE 3rd Avenue
Fort Lauderdale FL 33304

TEL. #

(954) 348-9455