Team and Scientific advisors

Specialist of scale up of technology and Quality Systems
22+ years' experience in QMS/manufacturing in global biotech industry.
Technology development, Process development and scale up for Recombinant, conventional, conjugate and subunits vaccines Establishment/implementation of QMS, Validations, facility design and conceptual layouts & risk management in existing and upcoming commercial units.

Davender K. Bhati
QMS, Vaccine technology development
24+ years of experience in QMS/manufacturing in global biotech industry Technology development, Process development and scale up for Recombinant, conventional, conjugate and subunits vaccines.
Formulation of single and combination vaccines
Establishment/implementation of QMS, Validations & risk management in existing and upcoming commercial units.

Jainendra Jain
Quality Head
22+ Years' Experience, Comprising of Manufacturing & QA in the Pharma and biological industry with expertise in CAPA, Audits, Compliances.
SME in facility design & set up, validations, risk management, GMP Audits for USFDA/EU/TGA.
Qualified ISO 9001-2015 Certified
lead auditor
Certified Associate Trainer
International Board of Certified
Trainers, Netherlands
ISPE certified Ambassador

Rakesh Kumar
Analysis and QMS
15+ years in analysis /control of biotech products specifically human and Poultry vaccines in global vaccines/ Biotech industry.
Expertise in analytical methods development, Validations and Quality Management Systems.
Well versed with animal handling and relevant studies/experimentation.

Vikrant Panwar
Associates/Scientific Advisor
38+ years of experience in QA and Corporate QA of various global Pharma giants & worked upon both APIs, Drug products & medical devices.
Worked with Rallis India, Lupin, Nicjholas Piramal, Torrent, Nektar Therapeutics & Zydus Cadila (Sr. VP as last position) in all spectrum of QA.
Experience of handling more than 80 Inspections including 45 of USFDA/EU/MHRA Member of PDA, ISPE and & FICCE Associated with PQE, Srl, Italy.
ISO 9001:2008 certification
ISO 13485 certification

Dr. Alok agarwal
Associates/Scientific Advisor
A Quality culture enthusiast with 23+ Years' experience, Comprising of QA in the Pharma and biological industry with expertise in CAPA, Audits, Compliances and Training.
SME in QMS/GMP audits & training
Conducted 120+ training sessions & successfully faced USFDA/EU/WHO-Geneva/Russian audits Faced ISO/OHSAS/GMEA audits Master trainer/consultant with Skill council-India in Pharma.
