We proudly represent a committed team of Regulatory Affairs and Quality Assurance experts. Our organization thrives at the intersection of regulatory strategy, CMC (Chemistry, Manufacturing, and Control), and Quality Assurance, with a distinct specialization in Generic Drugs, Complex Biologics, Aseptic Manufacturing & Sterile Fill Finish.
Product Development
Regulatory Project Management
Technical Manufacturing Support and
Oversight
Supply Chain Support
Process Optimization
Data Analysis
Aseptic Manufacturing/Sterile Fill
Regulatory Status
Global Health Authority and FDA Interaction & Meetings
Product Submission and Marketing Application Support(NDA, BLA, ANDA, and 510(k))
Special Regulatory Pathway Petitions
Mergers & Acquisitions
Litigation
Pharmacovigilance
Regulatory Project Management
Product Development
Technical Manufacturing Support and Oversight
Supply Chain Support
Process Optimization
Data Analysis
Aseptic Manufacturing/Sterile Fill
Onsite And Virtual Compliance Auditing Services (cGMP, ISO 9001:2015, ISO 13485, USP-NF, AATB, GLP)
Gap Analyses
Document and eDMS Compliance
QMS Implementation, Administration, and Oversight
CAPA & Deviation Management
Equipment, Process, Software, Cleaning/Disinfectant, and Facility Validation
Successful Audit Response
888 Pharmaceutical is a Global Regulatory Affairs Consulting firm with over 30 years experience in providing regulatory submission support for new and complex post-approval generic applications (ANDAs). We have successfully filed and supported new drug applications for small generic pharmaceutical manufacturers as well as fortune 100 pharmaceutical manufacturers.
Interested in a proposal? Connect with us Today.
Contact Details
US Tel: +1.909.576.6424
888 Pharmaceutical, LLC.
222 N. 13th St. Suite 200
Boise, Idaho 83702
