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Expertise

1) Rajashri Survase-Ojha (Founder and Managing Director of Raaj GPRAC and Raaj Pharma eLearning)

Mrs.Rajashri Survase-Ojha is a senior RA professional, GMP consultant and Lead Auditor-13485-2016 and has over 27+years of very versatile experience in pharmaceutical industry, starting her career FROM Scientist in R&D,[Analytical & Formulation],QA-QM, till GLOBAL regulatory Affairs. Expertise in getting marketing approvals of Generics, DRUG SUBSTANCE/DRUG PRODUCTS/MEDICAL DEVICES/OTC/Neutraceuticals & FOOD across the Globe.

Rajashri is the founder and Director in RAAJ GPRAC & RAAJ PHARMA eLearning, Thane-Mumbai since 2009- 2010 and completed 10 successful years as women Entrepreneurship. Raaj GPRAC is NSDC-LSSSDC Accreditated and an ISO 29993-2017certifiedinstitute.

She is RAPS qualified and also holds PG Diploma in Intellectual Property rights (IPR), Pharma Quality Management and is a Regulatory Submission expert of CTD/eCTD/ACTD/NeeS formats. She has TRAIN the TRAINER, Six Sigma Green belt, 7 habits of most effective people and Cornerstone leadership certifications.

She has published more than 18 Articles and Research papers in reputed journals.

She has Trained more than 15000 candidates till now on various aspects of GLOBAL Regulatory Affairs, GMP, GLP, GCP, GDP, Country-specific Regulatory Submissions(USFDA, EMA, ROW, ANVISA, WHO, ASEAN, SFDA, CDSCO-DCGI & Others), Quality Assurance & COMPLIANCE, 21CFR PARTS, GAMP-5, CSV, Clinical Research, Pharmacovigilance, Patents, Pharma Documentation and Pharma Management etc in Pharma & Biotech industry.

Hands on expertise in Regulatory Affairs(RA) and ‘Regulatory Intelligence’(RI) and setting up of new business process and operations of ‘Regulatory Affairs’ and ‘Regulatory Information Management (RIM)’ and Training centers across the globe.

Competent, diligent & result oriented professional experienced in Strategic Management, New Organizational Set-ups, Project Management, Resource Management, Compliance Management , Regulatory Submission Management across the globe.

Significant experience in Registration, Liasoning and marketing Approvals of pharmaceutical Drug substance and Drug Products. -Handled submissions of DMF, KDMF, ASMF, CEP/CoS and IND/NDA/ANDA/ANDs to different National & International Health Authorities. Supported Regulatory Audits for USFDA, UK-MHRA, EdQM, ANVISA, TGA, SFDA, TFDA, MHLW/PMDA, WHO and other local Health Authorities.

She is also associated with many leading education institutes/colleges in India as a ‘Guest faculty’

She is a Visiting faculty (Adjunct Professor)at JSS University in Mysore for ‘M.Pharm in Drug Regulatory Affairs’. ICT-UDCT, BCP, KLE, MET, NIPER, Sinhagad institutes, Bharati Vidyapith, Gehlot, HKCP, OCP etc.

She is a member of IPA, DIA, IDMA, RAPS, TOPRA, OMICS, FIP, UBM, Global Compliance Panel, IMS, IBC etc. and Chaired many scientific sessions organized for National and International Conferences. ASQ Member ID: 65583963

Honours:

  • Received a Sandoz award for Excellence in December 2004 for the Best Individual Contribution
  • Received a Best team support award for ANDA filings in Sandoz.
  • Received many Token of Appreciation from various Pharma colleges and Institutes from all over India.
  • She was awarded for ‘’ Women's leadership India Awards in Pharma Coaching ‘ by iiGlobal in February2017.

Certifications:

  • LEAD AUDITOR-13485[QMS- Medical Devises]
  • Six Sigma Green Belt trained
  • ‘Train the Trainer’ Certifications
  • Hands on eCTD certification
  • PG Diploma in Patents, Quality Assurance and QM
  • Certification in Cornerstone Leadership program designed for Sr. Managers in Hyderabad
  • ISO 29990-2010
  • LSSSDC Accreditation

2) Ram Banarse

A regulatory affairs professional backed up with experience in Pharmaceuticals, Medical devices, and Consumer healthcare products (OTCs). A dedicated, highly regarded professional with a wealth of transferable skills and a strong academic background. He possess12 years experience of pharmaceutical manufacturing & 25 years experience as a Drug regulator. Possesses excellent interpersonal and communication skills and the ability to get along with all levels of personnel. A resourceful, dedicated, hard-working, driven and highly committed individual with natural leadership skills.

Adviser to Pharmaceutical and Allied Industry (Food /Devices /Cosmetics etc ) on Techno legal issues pertaining to special acts like Drugs & Cosmetics Act & Drugs Price control, FSSAI . Have been associated with DCGI , FDA, CDTL, CDL, FSSAI New Delhi and FSSAI zonal offices. Well versed in the area of licence, registration , renewal, and maintenance for drugs and registration and maintenance and labeling of food under the new regulations of FSSAI

Asst. Commissioner

January 2008-May 2014 Mumbai area, India

To provide recommendations for registration/licensing of Pharmaceutical manufacturing units under the provision of the Drug & Cosmetic Act of India. Approval of Drug formulations [biological and non-biological] before manufacturing. Recommendation for registration of manufacturing units that fulfill all the criteria under WHO Good Manufacturing Practices [GMP] in coordination with Central drug authority. Technical Consultations for the layout plan of pharmaceutical manufacturing units to ascertain that manufacturing activities are carried out as per GMP standards. Quality Assurance: To ascertain that the manufacturing units are implementing all the Quality control parameters required for the drug manufacturing as per WHO GMP and amended schedule “M” and schedule “T” of Drug & Cosmetic Act of India. Blood Bank: Recommendation for the licensing/registration of blood bank units for proper layout planning and equipment’s required for testing. To establish coordination with office of National Pharmaceutical Pricing Authority of India to establish that the prices of formulation drugs are manufactured within the ceiling price as fixed by Govt. of India. To recommend the quota for a particular Narcotic drug under the provision of Narcotic Drug & Psychotropic substance Act of India.

 

Drugs Inspector 1990 -2008

Statutory audit of Retail and Wholesale drug establishments, manufacturing units and blood banks.
Inspection of blood banks for licensing the whole blood/blood components as per schedule “F (part XIIB)” of Drugs & Cosmetic Act.

To inspect the manufacturing units for Registration and Licensing as per the provisions laid down under amended schedule “M” and schedule “T” of Drugs & Cosmetic Act. Inspection of blood banks for licensing the whole blood/blood components as per schedule “F (part XIIB)” of Drugs & Cosmetic Act.

Unearthed the interstate rackets of spurious drugs and launched prosecutions in the court of law for spurious & drugs declared not of standard quality as well as the establishments running without valid drug manufacture /sale license.


Manufacturing 1978-1990

Well versed with the manufacturing oral doses form, general SOP , documentation, general compliance ,training and setting of new plant

Highlights of experience and achievements

1) He was elected to the prestigious post of Vice-President, & Chairman of Regulatory Affair Div Indian Pharmaceutical Association in December 2010-12.

II.He has an extensive experience in regulatory field and held important positions in FDA Maharashtra such as Assistant Commissioner (Intelligence Branch) His contribution and professional excellence has been recognized by way of awards and recognition:

  • Best Drugs Inspector Award from All India Drugs Control Officers' Confederation presented during 57th Indian Pharmaceutical Congress in December, 2007.
  • “Fellowship Awards” from the Indian Pharmaceutical Association in 2004
  • “Best Alumni Awards” from KMK College of Pharmacy in 2005.

III.  He is a good orator, communicator and a trainer, a fact recognized by national and international organizations by inviting him as faculty for seminars and workshops. He loves teaching and regularly shares his thoughts with the students of pharmacy, the Drugs Control Officers, the Professionals in Industry, Community Pharmacy and Consumer Organization.

He is a good orator, communicator and a trainer, a fact recognized by national and international organizations by inviting him as faculty for seminars and workshops. He loves teaching and regularly shares his thoughts with the students of pharmacy, the Drugs Control Officers, the Professionals in Industry, Community Pharmacy and Consumer Organization. He is founder member of the All India Drugs Control Officers' Confederation and has served AIDCOC. He has played a very vital role in Indian Pharmaceutical Association Maharashtra State Branch and was Secretary & as the President from 2004 to 2006 and during his tenure of President he has achieved “Best State Branch award “ twice.

3) Omprakash Sadhwani

Former Joint Commissioner & Drugs Controller

Food and Drug Administration, Maharashtra

KEY HIGHLIGHTS

  • 30 years of experience in enforcement of drug laws with expertise in detection and investigation of contravention cases
  • Best Drug Control Officer of India – All India Drug Control Officers’ Confederation – 2010
  • Gaurav Puraskar – Government of Maharashtra – 2008
  • Represented India in multiple national and international pharmaceutical forums
  • Former Secretary of All India Drug Control Officers’ Confederation (AIDCOC)
  • Former member of Drug Technical Advisory Board (DTAB) – 3 years
  • Certified Lead Auditor for ISO 13485 – Quality Management System for Medical Devices
  • Expert trainer for Adherence to FDA Acts and Rules with 50+ trainings conducted

PROFESSIONAL EXPERIENCE

Founder and CEO of Tiblo Consultancy Services, Mumbai

Jun 2019 to Present
  • Offer consultation to pharmaceutical companies on reglatory compliance related to Pharma GMP
  • Facilitate brand protection by guiding manufacturers against counterfeit products in the market
  • Engage in training programs to promote good manufacturing and distribution practices

Joint Commissioner – Drugs at Food and Drug Administration (MH), Nashik

Sep 2017 to Jun 2018
  • Authorized licences and controlled manufacturing of drugs, cosmetics and medical devices
  • Conducted 25 training programs for Drug Selling Establishments providing guidance to 8500 licensees
  • Supervised enforcement activities of all drugs and cosmetics acts and rules as Administrative Head of Nashik Division

Joint Commissioner – Drugs and Drug Controller of Maharashtra at FDA (MH), Mumbai (HQ)

Aug 2013 to Aug 2017
  • Drafted and implemented guidelines for effective enforcement of Drugs and Cosmetics Acts
  • Represented Maharashtra state in Drug Consultative Committee (DCC), India
  • Member of several committees of DCGI, overseeing implementation of various Central Govt. directives
  • Conducted various public awareness programs to promote safety precautions for medicine

Joint Commissioner – Law at Food and Drug Administration (MH), Mumbai (HQ)

Mar 2010 to Jul 2013
  • Oversaw the proceedings of law and administrative matters of FDA for Maharashtra state
  • Conceptualized and accomplished digitization of administrative affairs of FDA, Maharashtra
  • Implemented issuance of online WHO-GMP certificate and COPP using inhouse developed software
  • Initiated establishment of food and drug lab in Nagpur Division and upgraded the same in Mumbai and Aurangabad

Assistant Commissioner – Drugs Food and Drug Administration (MH), Thane

Jun 2007 to Mar 2010
  • Presided as the Secretary of Expert Committee for analyzing the strength of technical staff of Drug department and sufficiency of FDA Infrastructure in Maharashtra
  • As the Secretary of “Single use devices, reuse policy” committee, counseled the Chairman, Dr. W. B. Tayde, Director of Medical Education & Research, Govt. of Maharashtra
  • Jointly presented “Project Concern” at 61st IPC, 2009, emphasizing the role of pharmacists in healthcare management
  • As the Secretary of “Single use devices, reuse policy” committee, counseled the Chairman, Dr. W. B. Tayde, Director of Medical Education & Research, Govt. of Maharashtra

Assistant Commissioner – IB Food and Drug Administration (MH), Mumbai (HQ)

Jul 2003 to Jun 2007
  • Detected and investigated multiple cases of contravention of various Acts and Rules implemented by FDA
  • Coordinated with other state’s FDA for collecting intelligence and planning raids
  • Advocated and followed up on the matters against spurious drugs in Mumbai High Court
  • Appointed Training Manager for drug control officers at FDA, Maharashtra

Other Key Positions Held

  • Assistant Commissioner – Drugs at Food and Drug Administration (MH), Amravati
  • Drug Inspector at Food and Drug Administration (MH), Raigad
  • Drug Inspector – IB at Food and Drug Administration (MH), Mumbai (HQ)
  • Drug Inspector at Food and Drug Administration (MH), Thane
  • Professor at Smt. Geetadevi Khandelwal Institute of Pharmacy, Akola Medical Representative at Organon India Ltd., Kolkata

TRAININGS RENDERED

  • National Conference by WHO for Free Medicine schemes in India – New Delhi and Chennai, India
  • Mentor and Speaker at a training program on Investigation Skills by INTERPOL – Hanoi, Vietnam
  • Joint Regional Training Workshop on Surveillance and Reporting of SSFFC Medical Products by WHO – Jakarta, Indonesia
  • World conference on Access to Medical Products and International laws for Trade and Health in context to 2030 Agenda for sustainable development – New Delhi, India
  • World conference on Access to Medical Products and International laws for Trade and Health in context to 2030 Agenda for sustainable development – New Delhi, India
  • Expert Faculty and Course Coordinator for Improving Investigation Skills of Drugs Control Officers
  • Speaker in more than 50 training programs organized nationwide

RECOGNITION

  • Best Drug Control Officer Award All India Drug Control Officers’ Confederation – 2010
  • Gaurav Puraskar for outstanding service in State Governement – Government of Maharashtra – 2008
  • Nominated member of Drug Technical Advisory Board (DTAB) from 2015-2018
  • Member of Drug Consultative Committee (DCC), Drugs and Cosmetics Act, India
  • SKOKCH Order of Merit Award for WHO-GMP online certification system, developed inhouse by FDA (MH)
  • GOLD AWARD for successful deployment of “xlnindia” software in FDA (MH) for authorizing online licences and certificates – National Award for e-Governance, 2012-13

4) Mr. K. Anand (ADVISOR, RAAJ GPRAC)

Mr. Anand has over 39+ years of work experience in Pharmaceutical Industry, with giants like Lupin, Gelnmark, Famycare, Zydus Cadila, Dr. Reddys etc.

He has been responsible for spearheading research activities of various organizations to take products into USA, Europe, Canada and all over the world.

He has been responsible for spearheading research activities of various organizations to take products into USA, Europe, Canada and all over the world.

  • Mr. Anand has over 39+ years of work experience in Pharmaceutical Industry, with giants like Lupin, Gelnmark, Famycare, Zydus Cadila, Dr. Reddys etc.
  • He has been responsible for spearheading research activities of various organizations to take products into USA, Europe, Canada and all over the world..
  • With over three decades of technical knowledge and experience in the field of R & D, Quality Assurance, Quality Control and Quality Management, Regulatory Affairs in Indian pharmaceuticals Mr. Anand possesses a unique skill-set that empowers organisations to function better and more productively.

 

5) Dr. Saranjeet Singh (Professor and Head, Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER))

Professor and Head, Department of Pharmaceutical Analysis, NIPER, S.A.S. Nagar, India Leader, Stability Testing and Impurity Profiling Facility, NIPER with total financial Co-ordinator for training component under MOH&FW, GOI Capacity Building Project funded by IDA/World Bank.

Member, Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations, World Health Organization, Geneva Member, Scientific Committee, Indian Pharmacopoeia Commission Chairman

IDMA-APA Working group on Development of Indian Drug Stability Test Guideline, 2001-2002 Member, IDMA-APA Expert Group for the preparation of Guidelines on Stability Testing of Biologicals Member, Board of Studies

Faculty of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak (2007-2009)Outside Expert Member, Academic Council, Maharshi Dayanand University, Rohtak (2005– 2007)

  • Professor and Head, Department of Pharmaceutical Analysis, NIPER, S.A.S. Nagar, India Leader, Stability Testing and Impurity Profiling Facility, NIPER with total financial Co-ordinator for training component under MOH&FW, GOI Capacity Building Project funded by IDA/World Bank.
  • Member, Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations, World Health Organization, Geneva Member, Scientific Committee, Indian Pharmacopoeia Commission Chairman
  • IDMA-APA Working group on Development of Indian Drug Stability Test Guideline, 2001-2002 Member, IDMA-APA Expert Group for the preparation of Guidelines on Stability Testing of Biologicals Member, Board of Studies
  • Faculty of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak (2007-2009)
  • Outside Expert Member, Academic Council, Maharshi Dayanand University, Rohtak (2005– 2007)

 

6) Vaishali Kolar (HR Head, Raaj Global Pharma Regulatory Affairs Consultant)

Mrs. Vaishali Kolar has done her MBA & LLB with specialization in HR & Organisational Behaviour having versatile experience in corporate sector.

Behaviour having versatile experience in corporate sector. She is LLB and well-versed with all HR Policies, Procedures, functions like talent acquisition, change management, policies and process, performance management and general HR operations.

She has hands-on experience of pre and post employment verification as worked with the Asia’s largest background Company, First Advantage in India.

She believes that Human Resource is the most important resource of any Company.

  • Mrs. Vaishali Kolar has done her MBA & LLB with specialization in HR & Organisational Behaviour having versatile experience in corporate sector.
  • She is LLB and well-versed with all HR Policies, Procedures, functions like talent acquisition, change management, policies and process, performance management and general HR operations.
  • She has hands-on experience of pre and post employment verification as worked with the Asia’s largest background Company, First Advantage in India.
  • She believes that Human Resource is the most important resource of any Company.