Tushar Kaskhedikar

Tushar Kaskhedikar is Director of H&K group and responsible for oversight of all client efforts, as well as the firm’s strategic growth. His client efforts focus on providing strategic and operational assistance to technically-oriented entities in areas such as GMP, Pharmaceutical project designing, research and development (R&D), regulatory affairs, and quality assurance. His vision is to provide industry with practical, cost-effective solutions to regulatory challenges and is recognized as a leading PICs/EU GMP consultant.
Mr. Tushar holds a Master degree in Pharmaceutical sciences with a vast experience in Pharmaceutical factories. In his past experience, he served Indian multinational pharma industry for more than a decade and founded a strong based in Vietnam having worked for German multinational group STADA for more than a decade. During this tenure he was involved in designing PICs/EU GMP compliant projects inside Vietnam and other region of south East Asia. He has excellent skills in Pharmaceutical engineering, cGMP compliances as well as setting up of new factories as well as up gradation of old facilities for PICs/EU GMP compliance. He has sound experience of handling of PICs/EU GMP/US FDA inspections.

Dinkar P Chaudhari

Dinkar P Chaudhari is Associate Director of H&K group. He is mechanical engineer and has vast experience of more than 22 years in pharmaceutical and healthcare industry in the field of engineering design,documentation,qualification ,validation ,energy monitoring,HVAC designing. In his tenure ,he has given various types of engineering services to pharma companies in India,Vietnam,South Africa,Tanzania,Saudi Arabia,China etc. He has sound experience of handling of PICs/EU GMP/US FDA inspections.

Krishnamurthy Balasubramanian

Mr K.Balu has been part of H&K group as Associate Director-Business development and regulatory affiars.He has more than 28 years of professional experience in pharmaceutical industry and in regulated market of Europe. He spent his 15 years working in UK and other part of Europe where he was engaged in obtaining dossiers from a European based company and develop the dossiers for full submission in the EU by way of assisting validation data’s, stability studies, and clinical comparative bioequivalence. He has been instrumental to obtain more than 200 Generic Pharmaceutical Marketing Authorizations in U.K and The Netherlands over the last 5 Years. Additionally he is Proficient in current European CGMP guidelines, implementation, Contract Manufacturing and activities related to commercial and technical agreements with major Pharma companies.

K.Balu has ability to design and develop supplier agreements and technical agreements in line with EU requirements. He has been instrumental in submissions of CTD dossiers to the MHRA for more than 60 molecules. Vast experience of answering RFI queries in conjunction with production sites till satisfactory grant of Marketing Authorization. He has thorough knowledge of current and continuing GMP practices prevailing in the European Union. He is sound in strategic planning & implementing all policies & procedures ensuring timely deliveries of all products through effective supply chain management, in concurrence with SOP developments for product supply chain management in terms of ICH guideline requirements.

Kiran Patel

Mr Kiran Patel is Associate Director of H&K group and software engineer with experience of over 22 years in Pharmaceutical industry .He has vast Experience in Automation system (Programming, Installation Design and Testing) and validation. He has taken up several projects related to software in India, United Kingdom and Vietnam. He has hands on experience in validation of PLC and SCADA based controlled system in various pharmaceutical companies. He has rich experience in development of ERP systems for Pharmaceutical industry and validation of SAP system

Dinh Minh Hoang

Mr Hoang is Vietnamese engineer having more than 5 years of experience as QA engineer in EU GMP approved German company STADA in Vietnam. He has sound knowledge of PICs/EU GMP and faced several audits from Europe,Taiwan,Korea and WHO Geneva. Currently he is associated with H&K group in Vietnam.

Nilesh Chaprot

Mr Nilesh has over 10 years of experience in the field of Clean Room HVAC system validation. He is Exposure to certification audits from International Regulatory agencies Like USFDA, EU-GMP, MHRA, TGA, MCC etc.He has good Knowledge of all the current international guidelines related to Clean Room requirements .He is specialized in Validation of Compressed Air System, Nitrogen, and Pure Steam etc.
He has taken up many projects related to HVAC and compressed air system validation in India, China, Vietnam and Africa.

Y. Satishkumar

Mr Satish is Post Graduate (Chemistry) having around 14 years of professional experience in the area of Quality in Multi International API manufacturing companies like Mylan Laboratories & Aurobindo Pharma in India.He has the experience of regulatory audits like WHO, USFDA, KFDA, EDQM, PMDA, TGA, AGES, ISO, EU GMP and some of the largest multinational pharmaceutical companies all across the world.

He can provide general supervision and technical guidance for setting up an API factory. He has vast experience in the analysis, design, risk, testing, and deployment of all types of APIs. He can maintain ultimate responsibility for assuring that all products are defect free and compliant with technical specifications.

He can provide necessary definition, development and deployment of the pharmaceutical product quality assurance strategy, addressing all phases of product development. He has a desire for achieving excellence in customer satisfaction, process and product quality and reliability. He had been involved in setting up new API factory in China.

Dr Ursula Koller

Dr Ursula Koller has sound professional experience as a GMP inspector at the Austrian AGES PharmMed, which is in charge of sovereign duties in the field of regulatory and inspection on behalf of the Austrian government. She has conducted numerous regulatory GMP inspections on national level, both API and FDF producers, wholesalers, supply chain and QC labs. Moreover she was responsible for API and FDF inspections abroad in many countries in Asia, The Americas and non-EU-countries. Studying Pharmacy she graduated as a PhD at the University of Vienna, Austria followed by a career in the pharmaceutical industry, where she worked for GlaxoSmithKline and Sandoz. She is a certified EOQ Quality Auditor and Quality Systems Manager.

Apart from her background as GMP inspector, she has knowledge in the areas of medical, quality assurance, strategic sourcing of APIs, supplier auditing and MEP Consultant. She is also the associate consultant of H&K group.