Quest International Consulting

Overview

QICI is a consulting firm with a mission to help its clients address and resolve their regulatory, quality, and compliance issues faster and with a greater success.

With special attention to each client, we provide advice and hands-on help to our clients deal with FDA issues and to take their products to the market faster than the competition where taking the product to the market is mission critical. We strive to be of value to our clients. It is more than ever vital to assure that you properly present your submittals to FDA and other regulatory agencies in a timely and efficient manner.

As we all know meeting regulatory requirements is a time consuming task that requires time, resources, and experience. Meeting FDA requirements can be rather hectic even when you have enough experience but may be short on time and resources. Quest International Consulting (QICI) can help you with all of these aspects.

Standards & Methodologies

We offer a full range of regulatory affairs service from strategic planning and meeting with FDA to electronic submissions.

● Strategies planning and guidance throughout the regulatory submission process

● CMC section development & preparations

◦ Writing CMC (Module 2 and 3 sections) for drug products and drug substances

◦ Writing reports for completed studies

● Preparation of dossiers and submissions for DMF, IND, NDA, ANDA and BLA

● Preparation of required amendments

● Preparation of required Post-approval change supplements (PAS)

● Special meeting request and scheduling

● Meeting briefing package preparation & submission

● Critical review of prepared submissions

● Drug product labeling preparation

● Drug product registration and listing

● Facility registration

● Gateway set up for clients

● Electronic submissions of dossiers

● Helping clients to resolve their electronic submissions issues when they have in house publishing tools

Qualifications, Certifications, Accreditations & Licenses

QICI can help you with:

● Compliance audits

● Response to FD-483's and warning letters

● Supplier/Vendor and subcontractors audits

● Site change qualification audits

● Mock FDA inspection

● ISO 9001 and 13485 audits and assessments for ISO registration Validation (protocols, executions and reports; DQ, IQ,OQ,PQ)

◦ Equipment

◦ Facility

◦ Process

◦ Cleaning

◦ Equipment software

◦ Computer systems