Mr. Zain Ul Abidin

About

With over nine years of hands-on experience in pharmaceutical and biological sciences, I specialize in quality control, regulatory affairs, and working with advanced laboratory equipment. I currently serve as Deputy Director/ Federal Government Analyst at National Control Laboratory for Biologicals (NCLB), Drug Regulatory Authority of Pakistan (DRAP). In this role, I am the sole analyst for biological products in the country, ensuring their quality, safety, and compliance with global standards.

My day-to-day work involves using a wide range of specialized equipment, such as HPLC, GC-MS, PCR, Flow Cytometry, ELISA, and Gel Documentation Systems. These tools support the evaluation and validation of vaccines, sera, and plasma-derived products. I have extensive experience in both chemical and microbiological testing, and I ensure our methods meet the rigorous standards of the WHO and ISO/IEC 17025:2017.

I have led the implementation of Laboratory Information Management Systems (LIMS) and helped drive digital upgrades and data trend analysis initiatives. These efforts contributed directly to our lab achieving WHO GBT Maturity Level III. I also develop technical SOPs and protocols, and as a certified internal auditor, I regularly train staff on lab systems, method validations, and how to operate and maintain high-tech instruments.

In addition to my laboratory role, I’m officially nominated by DRAP and WHO as a GMP/GCP auditor, conducting inspections of bio/ pharmaceutical manufacturing facilities, clinical research sites, and testing laboratories. During the COVID-19 pandemic, I played a vital part in testing and evaluating vaccines and biological products under urgent timelines.

On the international stage, I’m an active contributor to the WHO Network of National Control Laboratories for Biologicals (WHO-NNB) and a member of the European Pharmacopoeia Commission, where I help develop and validate monographs for vaccines, sera, and vitamins. I also serve on technical committees for ISPE and the Parenteral Drug Association (PDA), providing expert input on regulatory guidance, manufacturing best practices, and laboratory standards.

Academically, I hold M.Phil. in Pharmacology and a Pharm-D, and I am currently pursuing M.Sc. in Drug Regulatory Affairs from the University of Nicosia, Cyprus. I have completed several certifications and training programs from respected organizations such as WHO, US-FDA, ISPE, covering topics like GMP inspections, pharmacovigilance, and laboratory quality systems.

Combining deep technical knowledge with global regulatory insight, I bring a practical and collaborative approach to ensuring product quality, public safety, and innovation in the health sciences field.

Areas of Expertise