Integrated Pharmaceutical Solution
Delivering Seamless End-to-End LifeCycle Services
Company Introduction
As a expertin the biotech plant sector, our expertise work as bridge between complex scientific research and commercial operational reality. We provide high-level strategic guidance to help organizations innovate, optimize, and maintain compliance
Our Mission & Origin
The consulting landscape has long lacked a one-window solution for the pharmaceutical market. To fill this void, the founders of FAAZ BIONTECH left their positions at leading global consulting firms and industry giants. Their goal was simple: to create a premier, specialized firm dedicated to the unique needs of the Pakistani pharma sector.
Our Multidisciplinary Team
Within a short span of time, we have assembled an elite team of experts to provide tailored solutions. Our collective brain trust includes Strategic Advisers: Business Analysts and HR Experts.Technical Specialists: Pharmacists and Engineers. Operational Experts: IT Specialists and Supply Chain Advisers.
Regulatory & Market Advantage
We offer in-depth regulatory understanding, specifically regarding DRAP (Drug Regulatory Authority of Pakistan). Our expertise enables our clients to secure approvals on a fast–track basis, allowing you to capture the 1st Market Advantage and stay ahead of the competition.
Infrastructure & Technical Excellence
With over 300 technical assessments of national and multinational pharmaceutical units across Pakistan, we possess an unmatched understanding of industry requirements. Our team of experienced engineers and project managers creates innovative, functional, and sustainable spaces tailored to your specific infrastructure needs.
Integrated Pharmaceutical & Biotech Services
FaazBioNTech delivers high value-added consultancy, engineering and turnkey project solutions in pharmaceutical and biotechnology sectors. Our services encompass validation, regulatory compliance, logistics implementation and maintenance systems ensuring operational excellence.
After Sales & Technical Support
Integrated and multidisciplinary after-sale and technical assistance service management, offering highly specialized support to ensure lifecycle performance and customer satisfaction.
Engineering & Projects
From concept development to commissioning and qualification, FaazBioNTech manages customized, innovative and effective turnkey pharmaceutical and biotechnology projects.
Process & GMP Consultancy
Guiding clients safely from initial concept to final approval by national and international regulators, ensuring validation and full GMP compliance.
IP6 Industrial Software
A scalable and parameterizable industrial software platform for digitalization of regulated facilities, fully GMP and FDA validable.
OUR INTEGRATED PHARMACEUTICAL SERVICES INCLUDE
PHARMACEUTICAL ENGINEERING
TRAINING & DEVELOPMENT
Biotech Services
Project Feasibility & Layout Designing
Designing of Layout Plan, Gap Assessment of layout plan, Designing of Testing Laboratory & Microbiological lab as per WHO, PIC/s and DRAP Requirements. FAAZ offers project management services to help you get from the initial idea all the way to getting production up and running in the new facility and in compliance with the relevant regulations. One step before building-in quality is ‘designing-in ‘quality. This is often covered in the initial planning, research, development and scale up of a product but also includes the preliminaryGMP facility design
GAP Analysis
We are your partners in ensuring and maintaining the highest levels of Good Manufacturing Practice (GMP). Our auditing options cover GMP Compliance, Regulatory Inspections and Post Audit Remediation Programs – all to PIC/s,TGA, FDA, EMEA and DRAP standards
Objectives
Current State
GAP Deseriptioon
Future State
Remedy
Cleanroom & Laboratory Construction
Cleanroom & Facility Design
Our consultants, architects, engineers and GMP course experts can assist clients from site selection through facility designs and processing systems, cleanrooms, and workflow designs.
Laboratory Infrastructure
Our experts assist in the development of Testing Laboratories and Microbiological Laboratories, ensuring all facility designs are as per current PICS requirements.
Instruments & Furniture
This is not only limited to designing / construction but also assist and providing laboratory standardized instruments and furniture for complete facility readiness
Validation & Qualification
Our One of the core strengths is providing Validation and Qualification services for not just routine validation types but also advanced validation and Qualification in line with the stringent guidelines of WHO, ISPE, PIC/s.
QMS & Documentation System
Our QMS services include but not limited to designing of Documentation system and controls, and Devising plans for stringent in-house auditing / inspection systems.
Risk Management & Engineering
We provide guidance on Quality Risk Management tools. The scope of documentation includes Production, QA, QC and Engineering departments.
Pharmaceutical Consultancy Services
Regulatory Affairs services include
Devising regulatory strategy.GMP audit response assistance including CAPA. Technical writing and preparation of the Common Technical Document (CTD).Post-approval regulatory compliance.DRAP and Other Regulatory Correspondences.Technical writing on Pharmacovigilance site master file and its complete attachments.
TRAINING AND DEVELOPMENT
We ensure your team is trained to operate in a regulated environment.The core competency topics for training are but not limited to.Principles of Modern CGMP & GDP compliance.Quality managementsystems.Equipment operation & maintenance. Data integrity & electronic records compliance.Health, safety, and environmental practices.Contamination control strategy and Principles of Quality Risk Managment