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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
Company Details
- Employees
- 2
- Founded
- -
- Address
- 642 Ne 3rd Ave, Fort Lauderdale,florida 33304,united States
- Industry
- Business Consulting And Services
- Website
- http://www.pharmobedient.com
- Keywords
- Fort Lauderdale.
- HQ
- Fort Lauderdale, Florida
Pharmobedient Questions
Pharmobedient's website is http://www.pharmobedient.com
Pharmobedient's LinkedIn profile is https://www.linkedin.com/company/pharmobedient
Pharmobedient has
2 employees.
View email and phone details for 2
employees at Pharmobedient.
Pharmobedient's industry is
Business Consulting and Services
Pharmobedient's top competitors are
Centessa Pharmaceuticals,
Cencora | Pharma Solutions,
Labq Asia & Europe,
Ast,
Abraxeolus Consulting,
Trio Medicines Ltd,
Pangea Pharmaceuticals,
Octavius Pharma Pvt. Ltd..
Pharmobedient's categories are Business Consulting and Services
Pharmobedient's founding year is 2009
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Top Pharmobedient Employees
-
Katie Dougherty
Consulting And Compliance
St Petersburg, Florida, United States, United States4abraxeolus.com, yahoo.com, pharmobedient.com, unimarkremedies.com2 .585.51XXXXXX
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