Expertise

  • Mrs. Rajashri Survase-Ojha is GMP and LEAD AUDITOR-13485[QMS- Medical Devises]

She is a senior RA professional, GMP consultant and Auditor and has over 27+ years of very versatile experience in pharmaceutical/Biotech 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 Managing Director of Raaj GPRACPVT. LTD. [‘Raaj Global Pharma Regulatory Affairs Consultants] Thane-Mumbai   since 2010 and completed 10 successful years as women Entrepreneurship. Raaj GPRAC is  an ISO29990-2010 certified  institute.

She was awarded  for ‘’ Women's leadership India Awards in Pharma Coaching ‘ by iiGlobal in February2017.

Awarded for WIB-2019 by Indo Global Chambers of commerce on 7th April2019 at Indore.

--She brings with her more than 27+ years of rich experience working for leading organizations like SPECTRUM Pharmatech, SYNERGY PHARMA UAE, Raaj GPRAC, COGNIZANT , FAMYCARE , NOVARTIS, GSK-TCS, GLENMARK, SANDOZ, Ciba-Geigy, UNICHEM Labs, and LOCAL FDA, Bandra.

She is RAPS qualified and also hold 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 8500 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

 

Publications:

  • Paper Presented at International Pharmanext conference at Goa on ‘Evaluation of Training required for Registration of Pharmaceutical Products in Regulated and Semi-Regulated Markets
  • Paper Presentation at National conference on the topic Clinical Trial in India: Current Regulatory and Ethical Overview
  • Article Published on Medical Devices, Need Attention in Express Pharma Pulse issue May1-15, 2011
  • Article Published on Importance of Regulatory Affairs in Express Pharma Pulse issue June1-15, 2011
  • Article Published on Call for harmonization of Regulatory system across the GLOBE in Express Pharma Pulse FIP-2011 issue Sept-1-15
  • Article Published on Herbal Pharmacovigilance-India Vs Global Outlook in Express Pharma Pulse IPC-2011 issue Dec-16-31
  • Abstract on Emerging Challenges and Issues in Higher Education from 4th Nov – 7th Nov Conference at Jaipur
  • Research Paper published in International journal of SAJMMR-Feb-2012 on Regulating and reforming the Pharma Curriculum in India
  • Book released on “RAAJ GPRAC GUIDE TO THE PILGIRMAGE TOWARDS PHARMACY PROFESSION”
  • OMICS; 2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs November 23-24, 2012 Hyderabad International Convention Centre, India, Pharma-2012. Abstract no. 1237:- Emerging issues & challenges in Pharma education and Training system: An overview
  • OMICS Abstract no. 1238:- Regulating the pharmacist: A change for the better
  • OMICS Abstract no. 1239:- Managing talent and performance in Pharma industry: Key to global successes
  • Regulatory Intelligence : Need of the hour; Published by AJPRD in April-2013
  • Research paper published by IJPRC in May-2013 on Evaluation of Training that calls for the Development of the Technical knowledge and Skills required for fresheres and associates working in different departments of pharmaceutical industry

 

A multi-faceted professional offering experience in HR Business Partnering; proficient in defining HR strategy consistent with business strategy & challenges and delivering sustained organizational growth in dynamic, highly competitive environment.

Achievement-oriented professional with 15 years of experience in Strategic HR Management in matrix structure with focus talent management, optimal utilization of resources, organization development, employee retention and change management.

Track record of delivering across global organizations like DHL, Deloitte Consulting and TATA AIG Life Insurance Services

Strategy architect credited with implementation of innovative and cost-effective HR initiatives to streamline business processes and capitalize on growth opportunities.

Experienced in Learning and Development, talent management, and succession planning f or improving the competence of the workforce and building talent pipeline.

Skilled in designing & applying a comprehensive performance management and competency framework to support  business& achieve ambitious growth plans; managed the PMS for a headcount up-to 10000 plus

Leveraging analytical skills across competency & skill mapping, employee skill index, career paths, scenario analysis and performance reviews. Proficient in identifying training needs across levels, customizing the learning projects, conducting/imparting the trainings and measuring the effectiveness of these programs

Enterprising leader with excellent communication and people management skills for leading personnel towards accomplishment of common goals.

Feb 2013 to July 2015- Deloitte Consulting- US India offices as Performance Management Specialist

Significant Accomplishments:

Delivered performance management cycle and succession planning for one of the largest consulting units having 10000+ employees for national and international locations

Defined the KPIs, Goals for the appraisal process and facilitated performance reviews, PIP planning and Intern Performance Management. Facilitated succession & career planning sessions for the leadership teams and provided analytics & HR support

 Jul’08-Feb’13 with Deloitte Consulting- US, Hyderabad  & Mumbai  as Talent Development Manager

Led Learning & Development implementation agenda for 3 service lines in coordination with Global Learning Team with a team of 4 Executives. Assessed trainings needs, gaps, and development opportunities and designed high quality learning solutions with best-of-breed agencies. Successfully delivered programs on Leadership development and soft skills. Promoted as a Learning Lead for India office- Enterprise Risk Services in December 2010 .Recognized as the Employee of the Month & Quarter and with SPOT Awards several times.

Richard Bandler Certified Neuro Linguistic Programming Practitioner May 2009

Certified and Licensed to administer the Thomas Personal Profile Analysis and its related instruments for Job Analysis, TNA and Training Effectiveness Monitoring

Certified Trainer with Credits for the City and Guilds International Training and Teaching program (1104)-UK in 2004

Dell- USA Certified Communication and Voice and Accent Trainer in 2005

Pragati Leadership Institutes “Inspiring Facilitator”-Train the Trainer Program in 2004

 

 

FORTY years of wide and varied experience in API business involving:

  • - Production and Engineering - Projects and technology transfer
  • - HSE & Quality - Audits (Regulatory, customer, ISO systems)
  • - Image building - Compliance (Statutory & Regulatory)
  • - EOU and SEZ units - Procurement (RM & capital goods)
  • - ERP systems (SAP) - Customer Care & Support
  • - Due Diligence (M&A) - Crisis & change management
  • - Strategy - HR, Admin, training and development
  • - Brown and green field sites - Sterile & oral antibiotics and non- antibiotics

The Key Deliverables:

  • I have had opportunity of developing and implementing many new commercially viable technologies of 7-8
  • steps of API for the first time in India
  • Besides this many breakthroughs in reducing the cost of drugs and eliminating the hazardous/expensive
  • intermediate steps of various drugs have been my achievements.
  • Present to board P&L performance on regular basis and capex approvals
  • Develop culture of transparent and ethical way of working
  • Improve compliance level – statutory and regulatory.
  • Create and implement high standards of EHS and quality
  • Deliver on time products and facilities with right cost, quality and time
  • Customer relationship management
  • Generate MIS and control on inventory and WIP
  • Team building, leadership and vision sharing.
  • Cost reduction, process improvements, preventive maintenance
  • Industrial relations, cordial relation with local community and authorities
  • Provide strategic direction to the organization
  • Newer initiatives like change management, increased use of IT tools, etc.
  • Interact with support functions

 

  • With over 39+ years of work experience in Pharmaceutical Industry like Cipla, Lupin, Watson, Alembic, Emcure, Marksons Pharma.
  • Dr. Nayak leads the research activity of various Indian as well as multinational companies.
  • He has a solid background in R&D, Quality Control, Quality Assurance and Regulatory Affairs.
  • He is one of the very few people of Indian Pharmaceutical industry who became business head with Quality background.
  • He has in-depth and hands-on knowledge and understanding of Quality systems, management and business requirements.
  • He is One of the Important ADVISOR to RAAJ GPRAC PVT. LTD.

 

  • 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.

 

  • Mr. Parthasarthy has over 40+ years of experience in Quality Control, Quality Assurance and Manufacturing in an MNC- Parke – Davis India Limited, an affiliate of erstwhile Warner Lambert, USA, now merged with Pfizer.
  • He has been functioning as a Consultant for over 16 years for public testing labs, Allopathic API and Formulation, Intermediate, Ayurvedic, Homeopathic Formulations and food Manufacturers.
  • He has visited over 100 Intermediate, API, Formulations units and public testing labs in India. He has worked as a Consultant and Trainer for over 100 companies in the last 14 years and has conducted about 200 to 250 compliance audits with other colleagues like Mr. C V Sastry, Mr. C. Suresh Babu and L. Rama Rao.

 

  • 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)

 

  • 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.

 

  • She is a Pharmacist with a rich, profound experience of 18+ years in all comprising of 5 years in formulation development in Cipla, Novartis & USV. Successfully developed the patent portfolio in companies like Glenmark & ROW2 Technologies for formulations & process development in 4 years.Presently into a talent acquisition profile in the pharma industry since 2 years. Interestingly headed the pharmaceutical vertical in a recruitment consultancy and lead a team of technical experts.Presently into a Manager-Operations role with one of the largest executive search firms serving clients all across the globe. Highly organized, energetic, detail-oriented person with strong people skills desiring long-term career opportunities in acquiring talent for the Pharmaceutical Industry.Promoted company’s image and employed brand recognition to clients and candidates.Proven capability to drive the recruitment process, multi-task and shift priorities.
  • Specialties: Technically sound in the subjects of Pharmaceutics, Patents and Talent Acquisition. Always aiming to be a people’s manager by providing the team with ample opportunities to groom and motivate. About two year’s experience in as Key Account Manager as well as Recruitment Manager.I am proficient in driving client and project specific recruitment drives.I have the ability to work with the most demanding clients as well.

 

  • A Medical Graduate with an overall experience of 15 years in clinical trials in the different capacities of 3 years as a medical officer with W.H.O including 2.5 years of experience as a Co-Investigator in a European Multicenter phase III clinical trial in Oncology Segment at Regional Cancer Center, Indira Gandhi Institute of Medical Sciences Patna.
  • Almost five year of experience as a Senior Clinical Research Associate and Research Officer at Lambda Therapeutic Research Limited at Mumbai and Ahmedabad.
  • One year of working experience as Senior Clinical Research Associates at Quintiles Research (India) Private limited – Bangalore a Global CRO in the field of Clinical Research.
  • Joined Siro Clinpharm Pvt. Ltd. Mumbai, in December 2006 as a Clinical Team Leader and Handled a team of 16 CRA’s and Senior CRA’s.
  • Manager- Clinical Research, Eli Lilly & company India Private Limited.
  • Currently working as Clinical Operations General Manager at Glenmark Pharmaceuticals Ltd; New Mumbai.

 

  • Dr. Khale has over 25+ years of work experience in Pharmaceutical Industry of which last 6 years she served as a Head of research activity of various Indian as well as multinational companies.
  • She has worked with Ferring International PharmaScience Centre, Unichem Laboratories, FDC limited, Aurobindo Pharma Limited, Nicholas Piramal India Limited, Aventis, IPCA Laboratories, etc. She has concrete experience in various areas of formulation research including all types of dosage forms, NDDS products, and generic drug development for various markets including US, Europe, Brazil, South Africa and Canada.
  • Dr. Khale has a wide exposure in scaling up activities, Optimization, Technology transfer as well as trouble-shooting at manufacturing stage and cost management of the products. She is well-versed with US and European Guidelines as well as Designing the documentation for regulatory submission including ANDA, CTD etc.
  • She has considerable experience in handling US FDA audits and ISO audits. She completed a course as an Internal Auditor by LRQA and holds an Indian Patent 234153 based on the development of Liposomal Inhalations.

 

  • With the total professional experience of close to 30 years in the field of healthcare industry, Sanjiv has successfully shouldered various responsibilities in many well-known companies in the field.
  • He has been involved in various functions such as Customer-support, Product Support, Applications support, Sales, Marketing and Business Development etc.
  • Sanjiv is a Post Graduate in Electronics from Mumbai University – with a qualification in Business Management.
  • With industry-wide contacts and network, he has accepted the responsibilities with Raaj – GPRAC for Marketing Support and Business Development.

 

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.
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

I.    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.

IV.  He is founder member of 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.