Sachin Bhalekar

THE NEXT BIG IDEA IS WAITING FOR ITS NEXT BIG CHANGER WITH Cyclone

Director Cyclone Pharmaceuticals Pvt Ltd and Director at GMP Software Private Limited. Author Interview Techniques For Pharmacy Students.

Director Cyclone Pharmaceuticals Pvt.Ltd. India's Leading GMP and Regulatory Consultant Director ,GMP Software India CEO, QERC India's Best Regulatory Training Centre Pune

B.Pharma,M.B.A wit than 25 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. Invented and Introduced worlds first PaperLess GMP Concept for Pharmaceutical Manufacturers.

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.

Experience

Pharma GMP and Regulatory Consultant

Cyclone pharmaceuticals Pvt Ltd กค Full-time

Aug 2011 - Present
Managing Director

GMP Software India กค Full-time

Jan 2020 - Present
CEO

Quality Excellence and Research Center

Sep 2015 - Present
Technical Director

NutraGlobe Pharma Internationals

Sep 2020 - Present
Director and Chief Consultant

Cyclone Pharmaceuticals Pvt Ltd Pune.

2007 - Present
Director

Cyclone India Infotech

May 2012 - Present
Managing Director

P A B Internationals

Feb 2019 - Jan 2020
Sr.Manager Corporate Quality

Mission Vivacare Ltd.

Mar 2011 - Oct 2011
Manager QA

Dr. Reddy's Laboratories Ltd

Jun 2005 - Aug 2007
Production Officer

Dr. Reddy's Laboratories Ltd

Jun 2001 - Aug 2003

Portfolio

Skills

Audititng

Quality Assurance

Pharma GMP

Regulatory Affairs

Pharmaceutical Industry

Analysis

GMP

GLP

V&V

Sop

FDA

Validation

Clinical Trials

Quality System

Lifesciences

Biotechnology

Product Development

Quality Trainer

Informatics

Technology Transfer

Pharmaceutics

Formulation

R&D

Standard Operating Procedure (SOP)

Awards / Achievement

Apr 2021
Covid Yodha By Rudra Foundation, Pune
June 2018
Quality Excellence Award By QERC India
Aug 2018
Best Industrial Pharmacist By Industry Academic Fourum Mumbai
Apr 2017
Pharma Ratna 2017 Young Achiever Award

Aug 2018
Invention Of PaperLess GMP

PaperLess GMP is the world's first all-encompassing Pharma manufacturing ERP solution, integrated with a complete Quality Management System. This validated GMP pharma ERP solution complies with 21 CFR Part 11 and adheres to the ALCOA Principle of Data Integrity. It offers both cloud-based and offline solutions..

Till Date
Completed 375 Quality And QMS Audits

Audits of quality management systems have been performed for companies both in India and abroad, focusing on compliance with EU and other regulatory standards.

Till Date
More Tan 250 GMP & QMS Training Sessions

GMP, QMS, and attitude development training programs are organized for various companies and colleges in India, aimed at internal development and mentoring individuals as pharma experts. These programs provide in-depth knowledge of the pharmaceutical industry, regulatory QMS audits, and pharmaceutical import-export processes.

Till Date
More Than 50 GMP Documentation & Intigrations For Pharma Manufacturing Companies

Prepared GMP documentation for over 50 companies to meet compliance requirements for WHO, EU, NAFDAC, USFDA, and other regulatory audits.

2021
Invention Of World First QMS SOftware

PaperLess QMS is the world's first all-encompassing Pharma manufacturing QMS solution, integrated with a complete Quality Management System. This validated GMP pharma ERP solution complies with 21 CFR Part 11 and adheres to the ALCOA Principle of Data Integrity. It offers both cloud-based and offline solutions..

CONTACT Us

Address

Vascon Garnet Bay,Viman Nager,Pune
India, IND

Phone

7722000506
7875351001

Email

Email: info@cyclonepharma.com