Meet the Minds Behind
Compliance & Innovation

Our strength lies in the knowledge, experience, and dedication of our team —

 committed to delivering regulatory excellence across healthcare and pharma.

                                                                                                                                                                Name : Mr. Amar Ishwar Sawalkar

               Role : Chairman And Managing Director 

      Expertise :  Manufacturing, Quality Operations & Marketing in Pharmaceutical                                formulation, APIs, Pharmaceutical, Intermidiate, Cosmetics,                                         Chemicals

  Introduction : B. Pharm. and M.B.A. graduate from Pune University, Mr. Sawalkar                                brings over 18 years of rich experience in the pharmaceutical and                                healthcare sector. He is driven by strong values, a sense of social                                responsibility, and a consistently positive attitude that shapes his                                leadership approach. 

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                                                                                                                                                                    Name :  Dr. Sanjeev B. Jadhav

             Role :  Independent Consultant

     Expertise : Expert at all QC/ QA activities. Extensive experience in Laboratory set                             up and daily activities in QC 

 Introduction :  Dr. Jadhav has successfully led key validation activities including                                      process, analytical, cleaning, HVAC, and vendor validations. He also                                supports technical pack preparation for R&D and has handled major                                audits such as USFDA, WHO-GMP, and multiple ISO and compliance                              certifications both in India and internationally.

                                                                                                                                                                   Name  : Mr. Satish R. Ramdhave

            Role  :  Independent Consultant

     Expertise : Expert in formulation and development of all dosage forms, MIS                                       reporting, and effective leadership in pharmaceutical packaging                                       operations, including team building, monitoring, and process control.

 Introduction : Mr. Ramdhave brings 37 years of pharmaceutical production                                             experience across multiple dosage forms. A seasoned trainer and                                     SAP-PP expert, he has handled major global audits (WHO, USFDA,                                   EU-GMP, Brazil-FDA) and led equipment planning from URS to PQ.

                                                                                                                                                                      Name : Mrs. Shweta Apte

              Role :  Independent Consultant

     Expertise : Expertise in Analytical Development with over 12 years of experience,                             specializing in method development, validation, product                                                     development  support for formulations and raw materials. skilled                                      in Module 2 and Module 3 dossier preparation for regulatory                                              submissions.

 Introduction : Mrs. Apte brings strong expertise in analytical document review                                       including specifications, STPs, COAs, protocols, and reports. She is                                   experienced in DMF handling, GLP and GDP compliance monitoring,                               and provides QMS support for CAPA, deviations, investigations,                                         change controls, and SOPs.                                                                              

                                                                                                                                                               Name : Sarveshwar Shivmurthy Swamy

              Role : Independent Consultant

     Expertise : Expertise in Quality Assurance and Computerized System                                             Validation  (CSV) with 12 years of experience, including preparation                             and execution of validation deliverables (URS, FRS, IQ, OQ, PQ, etc.)                           and comprehensive review of qualification documents pre- and                                   post-execution.

 Introduction : Mr. Swamy specializes in Computer System Validation and Quality                              Assurance within the pharmaceutical industry. He has extensive                                  experience in qualification and requalification of new and existing                                OSD, biologics, and sterile equipment and utilities, along with                                      strong expertise in QMS implementation.                                              

                                                                                                                                                               Name : Mr. Nitin Dhumal

              Role : Independent Consultant

     Expertise : Expertise in leading QA projects, conducting internal and external                               audits (onsite and virtual), and managing pre-inspection and mock                             inspection activities to ensure inspection readiness. 

 Introduction : Mr. Dhumal is a seasoned Quality Assurance professional with over                             17 years of experience in the clinical research industry, including                                 leadership in QA and QC. He has successfully led QA functions for                             supply chain and logistics, and conducted system audits at both                                 site and in-house facilities. Mr. Dhumal is also known for building                                 efficient quality systems aligned with global standards.

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