Quest International Consulting - 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.
Quest International Consulting
Description: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.


Quest International Consulting
26180 Enterprise Way, Suite 300 ,
Lake Forest, CA, 92630, US, Contact
Yasamin Ameri

Phone:
Fax:
949-215-3434
Email:

Website: www.qiconsult.com


Products and Services: Quest International Consulting Products & Services:

Quality systems:

·Development of quality strategy and set up quality system for start-up drugs and medical device companies ·Due Diligence and gap analysis evaluation of existing Quality Systems to identify following problems and issues ·Risk Assessments and Risk Management ·Site master file preparation (EU requirements) ·Quality manual preparation (ISO 9001 and 13485)

Regulatory Affairs:

·Regulatory affairs service from strategic planning and meeting with FDA to electronic submissions of applications to different regions of the world. ·CMC section development & preparations ·Preparation of full dossiers and submissions (DMF, IND, NDA, ANDA and BLA) ·Drug product labeling preparation and NDC registration ·Facility registration

Compliance Audit:

·Mock FDA inspection ·Response to FD-483's and warning letters ·Supplier/Vendor and subcontractors audits ·Manufacturing site change qualification audits ·ISO 9001 and 13485 audits and assessments for ISO registration


Experience: **Important Note: This information has been provided by the Company and has not been confirmed by Contract Laboratory Inc. It is recommended that you confirm all information prior to using this Company .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


Featured Products and Services

Quest International Consulting - Quest International Consulting Products & Services:

Quality systems:

·Development of quality strategy and set up quality system for start-up drugs and medical device companies 
·Due Diligence and gap analysis evaluation of existing Quality Systems to identify following problems and issues
·Risk Assessments and Risk Management
·Site master file preparation (EU requirements)
·Quality manual preparation (ISO 9001 and 13485)

Regulatory Affairs:

·Regulatory affairs service from strategic planning and meeting with FDA to electronic submissions of applications to different regions of the world.
·CMC section development & preparations
·Preparation of full dossiers and submissions (DMF, IND, NDA, ANDA and BLA)
·Drug product labeling preparation and NDC registration
 ·Facility registration

Compliance Audit:

·Mock FDA inspection
·Response to FD-483's and warning letters
·Supplier/Vendor and subcontractors audits
·Manufacturing site change qualification audits
·ISO 9001 and 13485 audits and assessments for ISO registration

Strategic planning ● Preparation, review, ● and submission of ● CTD and eCTD submissions ● Product registration ● SPL preparation ● Facility registration
Quest International Consulting - Quest International Consulting Products & Services:

Quality systems:

·Development of quality strategy and set up quality system for start-up drugs and medical device companies 
·Due Diligence and gap analysis evaluation of existing Quality Systems to identify following problems and issues
·Risk Assessments and Risk Management
·Site master file preparation (EU requirements)
·Quality manual preparation (ISO 9001 and 13485)

Regulatory Affairs:

·Regulatory affairs service from strategic planning and meeting with FDA to electronic submissions of applications to different regions of the world.
·CMC section development & preparations
·Preparation of full dossiers and submissions (DMF, IND, NDA, ANDA and BLA)
·Drug product labeling preparation and NDC registration
 ·Facility registration

Compliance Audit:

·Mock FDA inspection
·Response to FD-483's and warning letters
·Supplier/Vendor and subcontractors audits
·Manufacturing site change qualification audits
·ISO 9001 and 13485 audits and assessments for ISO registration
● Quality Systems setup (GMP, GLP, QSR, and ISO 13485) ● Gap analysis ● Due diligence audits