Driven by my passion for Microbiology, my desire to prevent
Microbiology related disruptions/flow blockers in supply chain and laboratory operations, I launched PinakInMicro consultancy


Pinakin Shah

Founder & Principal Consultant

Rapid Microbiology methods for product release

Deployed Rapid Microbiology methods for product release (Led Six sigma green belt project of Rapid product release to market using Celsis) and led multiple Global projects on Innovation and Simplification (Sterilization elimination, optimization of stability, product preservation etc).

Risk level-based assessment programs for Formulations and Raw materials

Developed science-based models for assessing Microbiological risk of raw materials and formulations.

US FDA (with Zero 483 Observation)

Led three consecutive successful certification/accreditation of Microbiology laboratory for US FDA (with Zero 483 Observation).Conducted Microbiological GMP audits for manufacturing sites, laboratories and suppliers globally.

Identified causes and action plans for challenging contamination issues

Investigated and identified root causes for challenging failures/contamination issues in manufacturing plants and raw material suppliers at Global level.

Partnered with Regulatory bodies

Collaborated and Partnered with Regulatory bodies e.g USP, ISO, BIS, Chinese Pharmacopeia etc to create Microbiological standards.

Our Services

Consultancy→
PinakInMicro offers consultancy in Microbiology design robustness, Audits and inspections, Investigations, Rapid methods, Contamination controls and Quality Systems for Microbiology.
Training→
PinakInMicro offers customized Quality and R&D Microbiology trainings to meet your unique needs. Webinars, workshops and training classes on formulation risk assessment, RM risk assessment, data integrity and compliance in Microbiology laboratory operations, Rapid microbial methods, objectionable organism assessment, Microbiological stability testing and method validation, environmental monitoring are few examples of trainings which we can offer.

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