888 Pharmaceutical – FDA Regulatory Compliance

Your Regulatory Affairs and Quality Experts

Pioneering Strategies in Generic Drugs, Complex Biologics, and Sterile Manufacturing

Trusted Globally for 25+ Years

What We Do Best

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, Tissue, Aseptic Manufacturing and Sterile Fill Finish.

Product Lifecycle

Our team excels in managing the intricate phases of the product lifecycle. We ensure seamless progression from product development to market success, providing comprehensive support at every step. Our expertise extends to enhancing manufacturing processes, optimizing supply chains, and conducting thorough data analysis to ensure quality and efficiency in aseptic manufacturing and sterile fill operations.

Product Development
Regulatory Project Management
Regulatory Operations
Technical Manufacturing Support and Oversight
Supply Chain Support
Process Optimization
Data Analysis
Aseptic Manufacturing/Sterile Fill

Regulatory Strategy

Our regulatory strategy specialists offer insightful guidance throughout your product’s journey. From determining regulatory status to facilitating global health authority interactions, we provide robust support for product submissions, marketing applications, and navigating special regulatory pathways. Our team brings a unique perspective, ensuring your regulatory strategy aligns with global standards.

Regulatory Perspectives

In the dynamic landscape of mergers and acquisitions, our expertise in pharmacovigilance, quality assurance, and regulatory compliance is pivotal. We provide specialized support in litigation, ensuring seamless integration of regulatory and quality aspects in CMC, thereby safeguarding your interests and facilitating successful transactions.

Regulatory Project Management

Our regulatory project management services ensure that your product development and manufacturing processes meet the highest standards. We focus on optimizing your supply chain, enhancing process efficiency, and ensuring data accuracy. Our approach includes stringent quality assurance measures in aseptic manufacturing and sterile fill processes, aligning with industry best practices.

Product Development
Technical Manufacturing Support and Oversight
Supply Chain Support
Process Optimization
Data Analysis
Aseptic Manufacturing/Sterile Fill
Quality Assurance

Onsite and Virtual Compliance Auditing Services

Our compliance auditing services encompass a wide range of standards, including cGMP, ISO, USP-NF, and more. We specialize in gap analyses, document compliance, QMS implementation, and CAPA management. Our team ensures comprehensive equipment and facility validation, leading to successful audit responses.

Compliance with 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

Authoring and eCTD Publishing

888 Pharmaceutical can assist your teaming the development of a filing by employing their eCTD authoring, reviewing, and publishing capabilities. eCTD publishing services provide comprehensive support, from SPL creation and submission to ESG transmissions and account generation. Our team of experts ensures seamless electronic submissions, maintaining the highest standards of data integrity and regulatory compliance.

Comprehensive eCTD services
Composition of Clinical, Nonclinical, and CMC sections in eCTD format
SPL/XML Creation & Submission
Document Technical Formatting
File Formats, Versions, and Folder Structure
FDA Forms
Document Lifecycle

US Agent for FDA & Electronic Submissions Gateway (ESG) Management

As your US Agent for FDA and ESG Management, we offer direct communication and oversight for regulatory compliance. Our services include documentation support, issue mitigation, and continuous regulatory updates. We specialize in ESG gateway setup, submission tracking, and ensuring the integrity of your submissions.

Regulatory Compliance Oversight
Documentation & Submission Support
Issue Mitigation
Regulatory Landscape Navigation
Status Monitoring
Continuous Regulatory Updates
Electronic Submission Gateway Setup
Submission Tracking
Data Integrity Checks
Troubleshooting
Submission Archiving

25+ Years Industry Experience

Experts in the Industry

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) and new drug applications (NDAs). We have successfully filed and supported new drug applications for small generic pharmaceutical manufacturers as well as fortune 100 pharmaceutical manufacturers.

Gene Ioli

Senior Regulatory Affairs Consultant

John André

Senior Regulatory Affairs Consultant

Nathan Quintanar

Pharmaceutical Quality and Regulatory Affairs Specialist

Contact Us

Interested in a proposal? Connect with us Today.

Contact Details

Email: [email protected]
Phone: 1.949.378.3884

888 Pharmaceutical, LLC.
222 N. 13th St. Suite 200
Boise, Idaho 83702