Sachin Bhalekar

Summary

Director, Cyclone Pharmaceuticals Pvt.Ltd….India’s Leading Regulatory Consultant
Director, Pharma QA…India’s Leading GMP and QA Consultant
CEO, QERC…India’s Best Professional Training Centre Pune

B.Pharma,M.B.A, with more than 17 years Quality Experience in Pharmaceutical Industry, A Lead Auditor and Quality and Regulatory consultant of India. Sachin Bhalekar is well known in GMP Training for Pharmaceutical Staff. Another area of expertise is cost effective production management for Small Scale Pharmaceutical Manufacturers.

Expertise:

Quality Assurance: Great experience in the field of Pharmaceutical Quality assurance. Developed a full proof documentation control system for small scale pharmaceutical companies which have been well appreciated by many regulatory authorities including European and US GMP Consultants. Crystal clear knowledge about the concepts of GMP and Quality Assurance and never got confused in quality decisions about different Formulations. Having expertise in Explaining the market complaints and resolving it.

Auditing: Till now conducted more than 200 different Quality Audits for small scale Pharmaceutical Companies and suggested best ways for compliance. Having skill for development of system through the audit points. Is known for his eye for review in pharmaceutical company.

Trainings: Sachin Bhalekar is having great communication and convincing skill which made him as very good and well known GMP and Quality trainer in India. Till now delivered many training sessions to multinational, middle scale and small scale pharmaceutical companies.

Regulatory Consultant: Having great hand in Compilation and review of dossiers for almost all countries and regions of world and having confidence of resolving all kind of regulatory queries, the dossiers reviewed or compiled under guidance of Sachin Bhalekar is always having a assurance for getting registered and he is being known as Man with Regulations.

Apart from this he is having expertise in plant project consultancies and having skill of finalisation of projects with his good coordination with other experts.


Scope of Experience

Team Leader, Positive attitude, best and practical approach towards Pharmaceutical quality Systems, believes that GMP is not expensive it can be achieved with little efforts and also believes that quality can not be in percentage its always 100%.


Market Sector Focus

Small scale Pharmaceutical manufacturers and Exportors.


Relevant Assignments

Conducted more than 200 Audits for small scale pharmaceutical manufacturers and API Manufacturers, Delivered many GMP Training sessions for Pharmaceutical manufacturing staff from many small scale pharma manufacturers.

More than 200 Products dossiers have been compiled and registered under Sachin Bhalekar’s guidance and which was including EUCTD,ACTD CTD and many more formats.


Qualifications & Registrations

D.Pharm,B.Pharm,M.B.A, Registered Pharmacist


Projects

Turn Key project for Up gradation of GMP and Plant for PICS,WHO,EU Handled successfully.

Working on First ever 100% GMP System software for Pharma Industry Known As PaperLess GMP


Qualifications & Registrations

Worked with Cipla, Dr.Reddy’s Laboratory Ltd.and
Currently Director Cyclone Pharmaceutical Pvt.Ltd.,
Director PHARMA QA and
CEO of Quality Excellence and Research Centre Pune


Books Under Publication

Advanced Drug Regulatory Affairs
Advanced Quality Assurance
Positive Approach towords GMP
GMP Attitude –A result oriented Quality Integration


Areas of Expertise

Audit Consultancies,
Pharmaceutical GMP Consultancies,
Documentation Consultancies,
Regulatory Consultant,
Plant Setups and
GMP Trainings.