Pharmobedient Information

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 a DMF or IND/NDA/ANDA or simply putting some SOPs — we are here to help in all aspects of your regulatory and product development needs. Services we offer: US Agent Services - Establishment Registration, Self Identification, NDC Listings, CARES Act Drug Reporting Controlled Correspondence Submission DMF, IND, NDA and ANDA preparation Pre-IND, pre-NDA and pre-ANDA meetings eCTD submission outsourcing eCTD life cycle management Electronically File (Pharmobedient maintains a Web Trader (ESG) Account) eSubmitter Service (author, review, publish, and package electronic CMC submissions) Animal Health - FDA CVM Services: Drug Development, CMC & Regulatory Strategy, Clinical & Safety Technical writing and reviewing Regulatory strategy Structured Product Labeling (SPL) services Suitability Petitions Citizens Petitions SOP Development Quality Agreements Vendor Audits Mock FDA Inspections Warning Letter & 483 Responses Finished Product Market Release (for virtual manufacturers) CMO qualification and oversight Drug product technical analysis Dossier review Due Diligence Assessments Technical Transfer Assessment Pharmacovigilance Services