M.Muneeswaran –Chairman

Mr. Muneeswaran is a post graduate in engineering from the College of Engineering, Guindy , Chennai.  He has a rich experience of 25 years in engineering, procurement and management and has held managerial position in reputed Multi National Companies.

 

He is a certified Project Management Professional from Project Management Institute,U.S.A  and a  Chartered Engineer of Engineer Council –UK.  He is also an Associate Value specialist from SAVE international, USA and a member of Toastmaster International-U.S.

 

 

M. Ganesan – Managing Director

Mr. Ganesan is a self-made technocrat. A Masters Degree holder in Applied Sciences from College of Engg, Anna University, Chennai, he has grown from working on the bench as a Chemist to the Managing Director.  He is now recognized by the Pharmaceutical and Biotechnology Industry as an expert in the bio-analytical field in India.  He established stringent quality GLP and GCP standards meeting world regulatory requirements in several Indian CROs.  He ensured that his experience was translated into implementing the highest standards in facilities and in operations of his own CRO, meeting and exceeding his customer expectations. A scientist to the core,  had the vision to put together the human capital in establishing a contract research organization that has earned acclaims from its customers and recognized by governmental regulatory bodies including the DCGI, NABL, IS) 9001:2008, ISO 10015, CAP, AFSSAPS, ANVISA and US FDA, . 

 

Mr. Ganesan has translated his core strengths – analytical approach and commitment to set goals – to his team of dedicated professionals, and enhanced it with tested management and performance promotion tools such as the Balanced Score Card system.  Micro Therapeutic Research Labs is perhaps one of the first CROs in the India to implement Balanced Score Card system throughout its workforce from management to maintenance

 

 

Dr.CT.Viswanathan – Advisor

Dr. Viswanathan functions in an advisory role as a consultant (since Dec 2011). He is the former Associate Director in U.S. FDA  for many years and represented FDA in OECD GLP .

 

He facilitates data quality and data integrity in the organization by providing regulatory and scientific guidance as well as training for Organizational Excellence.

 

 

Dr. V. Mohanram : Head - Clinical

 

Dr.Mohan ram is a qualified medical graduate with diploma in Anesthesiology, passed MBBS in the year 1987 from Madras University and Diploma in Anesthesiology in the year 1992 from Dr.MGR medical university. After graduation he worked in various hospitals managing ICU and giving Anesthesia to minor and major surgeries. He has more than 25 years of experience as Medical Practitioner and managing ICU.

 

He has attended various training sessions on Good clinical practice and involved in clinical trials for the past 4 years. He conducted more than 200 BA/BE studies in the capacity of Principal Investigator. He has experienced in effective Clinical Trial planning specially Phase III & IV and BA/BE studies in Patients.

So far he has handled 11 projects in various sites with a total number of 506 patients.
Handled many regulatory audits such as DCGI, ANVISA, USFDA and AFSSAPS.

 

 

Dr. L. Vengadassalapathy, MBBS, MS, MCH : Principal Investigator

 

Dr. Vengadassalapathy is a Medical professional completed MS in General surgery and MCH in cardiac Thoracic Surgery.  He has rich experience of 30 years in Cardio Thoracic Surgery and worked as Professor of Cardio Thoracic Surgery in Madras Medical College, Chennai.

 

He is also been awarded Fellowship in Research by JIPMER and Madurai Medical College.  He has attended several national and international symposium as well published several Papers in Trauma, Prosthetic value infections, Cardiac anatomy, and Comparative Genomics. He had involved in trails related to bleeding problems in open heat surgeries in children. He has authored the first Research Methodology Handbook for Medicine in Tamil language. He is a Phd guide in Dr. MGR MEDICAL UNIVERSITY & ANNAMALAI UNIVERSITY

 

He has been conferred with FRCS, (GLASG) from ROYAL COLLEGE OF PHYSICIANS & SURGEONS OF GLASGOW, UK.

 

As a principal Investigator, he is responsible for ensuring the BA/BE studies conducted at MTR as per the GCP guidelines.  He is heading the clinical department and managing a team of more than 25 Clinical Research Associates and scientists.

 

 

Dr. Sridevi Muthusivam: Principal Investigator

 

Dr.Sridevimuthusivam is a Medical graduate completed MBBS from Tamilnadu Dr MGR Medical university. She  has completed her diploma in clinical research and pursuing her masters in health science (diabetology) from Annamalai University. She has been awarded certification    from American heart association for basic life support and advanced cardiac life support. She is having experience of 6years in phase trials and General practice. She is having hands on training in ICU management and emergency trauma unit. She has published more than 6 papers in pharmaceutical journals. she is responsible as principal investigator for BA/BE studies  and ensuring all activities are carried out as per GCP compliance.  She is heading the clinical department and managing a team of more than 25 clinical research associates and scientists and protocol writing team. She is experienced in handling and submitting studies for various regulatory.

 

 

Dr. S. Nandakumar: Principal Investigator

 

Dr. Nandakumar is a Medical graduate who has completed MS from Bharathiyar University   He has a rich experience of 30 years working as a general surgeon in reputed hospitals.   He also worked as a Managing Director of a reputed private hospital in Coimbatore and was taking care of ICU and CCU patients.

 

As a Principal Investigator, he is heading a team of 10 Clinical Research Associates and scientists at our Coimbatore Branch and responsible for the smooth functioning of BA/BE studies according toe the GCP requirements.

 

 

Mr. Viswanathan: Manager – Bio Analytical

 

A Master degree holder in Pharmacy with Pharmaceutical Chemistry as specialization from Birla Institute of Technology, Ranchi. He has started his career as marketing executive in Kopran and in Novartis Limited and then as Scientist in the department of Clinical Pharmacology and Pharmacokinetics at Ranbaxy Research Laboratories, Gurgaon. He has 12 years of experience in the field of pharmaceuticals and Bioanalytical services. He developed and validated various Bioanalytical method for drugs and metabolites including endogenous substances in accordance to GLP and regulatory requirement. He  developed and validated method for several challenging molecules, hormonal substances and endogenous compounds. Completed studies were submitted to different regulatory and successfully passed the regulatory audits and products approved by regulatory like USFDA, WHO, ANVISA (Brazil), MHRA (UK), TG(Australia), AFSSAPS (France), and Health Canada.

 

He is heading Bio-analytical department and managing a team of 40 Research Associates and Scientists. He is responsible as a study director and Bio-analytical investigator in conducting clinical trials and ensuring the data integrity in accordance to regulatory compliance. He is also responsible in giving continuous training to his team on the current regulatory requirement and trouble shooting on the instrument LC-MS/MS while developing Bio-analytical method for drug substances.

 

 

Mr.Sankar : Manager- Analytical

 

Mr.M.Sankar is a Master Degree holder in Chemistry from Annamalai University.   He has 16 years of experience in Analytical field and has thorough of knowledge of GMP, GLP. During his association with the Pharmaceutical industry and Analytical Research centers, he has faced various regulatory audits such as USFDA, WHO, DCGI, AFSAPPS and NABL.

 

He has Expertise in Analytical method development, Stability studies ,Impurity profile, Trace metal analysis, Residual solvent analysis, Diffusion studies, Dissolution studies and validation of Analytical and Bio Analytical methods.

 

Well versed  in Team Development and Management, Effective Manpower Utilization, Qualification of the Instruments and Equipment, GCP and GMP implementation, implementation of Quality Standards, Change control Management, Failure Investigation, CAPA and  implementation of Deviation management.

 

 

Ms. R.Abiraamasundari : Manager-Quality Assurance Operations

 

Ms. R.Abiraamasundari is a post graduate in  Pharmaceutical technology . She started her career as a Research Associate in Bio-analytical Department and reached  the position of Manager-QA Operations through her commitment and dedication. She has been associated with Micro Therapeutic research Labs since the  inception of the company.

 

She has an experience of more than five years holding different responsible positions. She is heading the entire QA operations of MTR. Hands on experience in delivering quality documentation to various regulatory.

 

 Successfully faced 3 USFDA audit, one French audit (AFSSAPS), one Brazil Audit (ANVISA) and accord approval for all studies and systems.

 

Well experienced in the system requirements for Bioavailability and Bioequivalence studies and implementing the same as per the applicable regulatory requirements.

 

She has an experience in submitting studies to various regulatory authorities such as USFDA, MHRA(UK), TGA (Australia), MCC (South Africa), ANVISA(Brazil), AFSSAPS (French) and Health Canada.

As a Quality Manager, to her credit, she completed more than 600 BA/BE studies as a part of QA team.

 

 

Mr.Medhavi Natarajan: Quality Manager – Diagnostic Laboratory Services

Mr. Medhavi, a professional Biochemist, pursuing his Ph.D in the discipline of Biochemistry, did his Masters in Biochemistry from the Annamalai University in 1992 and his Master of Philosophy in Biochemistry from the Bharathidasan University in 2008. 

 

 Mr. Medhavi has 19 years of experience in the diagnostic field and held various senior positions.

Mr. Medhavi Natarajan leads the core team of Diagnostic Laboratory. He has played a key role in the evolution of MTR’s Diagnostic Laboratory Services from a small-sized lab into a national-level respected laboratory with CAP & NABL accreditations.

 

Mr. Medhavi is well-trained in ISO 15189:2007 and passed in the examination of ‘Internal Auditor for Medical Laboratories - ISO 15189:2007’.  Mr. Medhavi has also been a member of the All India Clinical Biochemist Association (ACBI ) of India and he  has presented  papers on Laboratory quality Control & diabetes  in many Conferences & in various Universities.

 

 

Dr. G. Shanthi: Sr. Scientist

 

Dr.G.Shanthi, Doctorate in Life Science with specialization in Molecular Genetics from Madras University, has made her career as scientist in a GLP accredited preclinical CRO. She has six years of experience in preclinical toxicology and completed nearly 250 studies for various regulatory submissions. She was well trained in GLP principles; ISO 10015 and faced many GLP audits successfully.

 

Her experience is affirmed at MTR in setting up the preclinical department as per GLP standard, build rapport with clients and organization of scientific and administrable meetings.

 

She has expertise in designing protocol, performing studies and reporting according to clients and regulatory requirements, scripting SOPs and its implementation and adherence to Quality in all walks of preclinical studies and activities. She participated in International and National workshops and published seven research articles.

Her Strength is Team work, Team development, Faith and Commitment towards the Tasks with adherence to Quality and Ethics.

 

 

Ms. Charumathi : GLP-GCP Coordinator

 

Ms. S.Charumathi is a Master Degree holder in Chemistry from Madurai Kamaraj University. She has 20 years of experience in the field of Quality Control Analytical Lab and has through of knowledge of GMP, GLP. During her association with the Pharmaceutical industry she has faced various regulatory audits such as USFDA, WHO, DCGI, AFSAPPS, ISO 9001:2008, ISO 10015 and NABL.

 

She is a Critical observer of the Analytical documents, Persistent towards implementation of systems,   Strong Determination towards target & result oriented work culture

 

Her area of Expertise is, Team Development and Management, Effective Manpower Utilization, Qualification of the Instruments and Equipment, Scheduling the Calibration of the Instruments and Equipments, GCP and GMP implementation, implementation of Quality Standards, implementation of Deviation management, Change control Management, Failure Investigation and CAPA.