Your Trusted Partners for Quality Assurance and Regulatory Services…
About CRQA
CRQA is an independent auditing and consulting firm based in Delhi, INDIA. We are an organization comprised of people specializing in Total Quality Management. We provide full range of GCP, GLP, quality assurance audits on a global basis. Our team provides a comprehensive range of quality assurance services, including auditing, consulting, SOP development and training to pharmaceutical, biotechnology and healthcare industries who are involved in Clinical research and development.
WHAT MAKES US DIFFERENT?
We are not a CRO. We are a firm comprised of auditors specializing in Total Quality Management. Our expertise covers GCP and GLP. We have scientific experts to cover quality in protocol design and to advise on training needs. We offer our clients a team of highly qualified experts who provide comprehensive training in GCP, conduct of Phase, I to IV studies.
OUR TEAM
The team comprises of experienced auditors who have a vast experience in the GxP regulated industry in conducting in house audits, external audits, CRO Audits, preparing site for regulatory Inspections, carrying out mock Inspections , training, consultancy etc. With over 10 years of combined industry experience, our group provides a full range of clinical audits from phase I to phase IV studies on a global basis. The group has gained experience in the monitoring, project management, quality assurance, team building and training of clinical research professionals. They have set up QA and Training unit and have prepared many sites for inspections and faced external audits in their career.
CRQA GMP AUDITOR
Over nineteen years of experience in Quality and technical operations of pharmaceutical formulations like tablets, liquid dosage, soft gel capsules, capsules, herbal medicine, herbal cosmetics, pharmaceutical APIs and medical device. Skilled in decision making, selection of optimistic approach and negotiation for the implementations of the decision, strong inter personal skill and result oriented and as a Quality Conscious Personality. Well versed with cGMP/GLP regulations for API’s and dosage forms. Hands-on with USFDA, MHRA, TGA, HSA, Gulf FDA and ISO requirements and audits designing, validation, setup, technology transfer and start-up of new pharma facility. Expert in internal, vendor and third party audits in compliance with cGMP and ISO standards.
Dr. Subodh Bhardwaj – Director Scientific & Medical Affaris – CRQA
An innovative Medical Doctor with Post Graduation in Pharmacology and more than 30+ years of experience in Clinical Medicine, Clinical Research, Pharmaco-vigilance and Regulatory affairs. Varied experience of 20 years in the Bio- Pharmaceutical Industry with reputed companies like Serum Institute Of India, Sanofi Pasteur, Aventis, Shanta Biotechnics, Serono, MBL, Crucell and interactions with WHO, Ministry of Health, DCGI, DBT, ICMR, IMA, IAP, OPPI, APACHE, APCRI.
Planned and completed over 100 clinical trials ranging from Pre-clinical, Phase1-4 and pharmaco-epidemiological studies. Possess exemplary skills in Regulatory affairs in India and fully updated on EU, US regulations. Have worked in Pharmaco-vigilance since 30 years with some interesting publications. Excellent Medical writing skills and Editorial experience with Indian Journal of Pharmacology. Over 60 publications in National & International Journals. Have actively published several product monographs, PILs and publications for public interest. Have been M.Pharm & Phd guide at University of Pune. Excellent Public speaking and Analytical skills. Widely travelled and have done clinical trials in 10 countries across the world. Proven track record in the health sciences field.
Anupma Tickoo, B.Sc, B. Pharm – Regulatory Affairs Consultant
Anupama has over 23 years of experience in the field of Regulatory Affairs with the companies like Parke Davis; Ranbaxy, Panacea Biotec and Apcer. She is approved analytical chemist for Delhi Drug Control and Maharashtra Drug Authority. She has vast experience in handling all regulatory documentation, new drug registrations, NDAs, regulatory filings for EU and other markets and host of other regulatory activities. Anupama’s experience includes:
  • Filing of New Drug Applications with DCGI.
  • Preparation and review of Standard Operating Procedures and other documents, including change controls relating to Production and Quality Control
  • Ensure cGMP and regulatory compliance in manufacturing unit.
  • Vendor audits for raw materials / Contract Manufacturers
  • Review and investigate the complaints and records of adverse reactions.
  • Executing regulatory activities for India with following specific responsibilities :
    • Drug Manufacturing (Licences) and renewals from local drug authorities.
    • Inspection and licensing of manufacturers.
    • Coordinating with Drug Authorities for Free Sale Certificates and Certificate of Pharmaceutical Products.
    • Compilation of documents for site registration & product registration as per Schedule D (I) & D (II).
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Dr. Sanjukta Bhattacharya Clinical Research & Medical Writing Expert
PhD is a pharma professional with 14 years of industry experience including 9 years in clinical research and 5 years in project management of NCE preclinical & clinical development. She is skilled in conducting ICH-GCP and Schedule Y of Indian Drugs and Cosmetics Act governing clinical trials. She has extensive experience in managing multicentric trials across India, Asian and African countries. She has worked in Ranbaxy Research Laboratories, Pharmacia (Pfizer) and LG Life Sciences in multicultural environment.
She has also been a visiting faculty at Jamia Hamdard University, Delhi where she has taken lectures for post-graduate students of clinical research.
At Ranbaxy, she lead the clinical development of Synriam, an antimalarial – India’s first new drug which was launched in 2012. She has received various awards for demonstrating commitment and contribution in clinical research. She was recently felicitated by the former President of India, Dr. A.P.J. Kalam for exceptional contribution in development of Synriam.
Mr. Sunil Pandita
Sunil is an experienced clinical research professional with an edge over the Quality Assurance and with a post-graduation in Biotechnology from Bangalore University. Sunil has been part of Global CROs and has worked on various global projects across various therapeutic areas. Sunil has an extensive in preparing the investigator sites for various regulatory inspections and Quality Assurance being the specialized area of expertise.
Sunil has worked with organizations like Quintiles Transnational and Inventiv Health Clinical; Sunil has handled various global studies as lead and has managed the transfer of data to the regulatory agencies through sponsors for the final approval of the molecule and has the thorough knowledge of various clinical databases. Worked on various clinical trials in Asia Pac region, and is through with Phase III and IV clinical trials. Sunil has widely travelled in India and abroad for the work. Sunil is a seasoned Quality Assurance professional with an expertise to perform Investigator site audits, Data management audits, Process audits and preparing the sites and organizations for the regulatory inspections.
At CRQA, Sunil is supporting the team of Quality professionals and managing the projects which require Quality support.
Mr. Hari Kumar
Mr. Hari Kumar, A mid-senior level executive with over 12+ years of progressive experience within the clinical research/GMP Industry, with specific expertise in Quality Assurance/Clinical Operations, Project Management, process development and Implementation, Consolidation/Integration of Operational Processes and the preparation of standard operating procedures to improve operational efficiency. Proven performance in project management with the delivery of desired results. He is Masters in Science and has worked for Novartis, ClinTec, Omnicare and Lotus Labs.
Dr. S. Karim, PhD Pharmaceutical Medicine
Dr. S. Karim, PhD Pharmaceutical Medicine, is a clinical research professional based in India with over Ten years experience in clinical research and five years experience in conducting quality assurance audits and assessments in India and China Quality Assurance Management and experience of a wide range of audit programmes worldwide including:
  • Investigator Site Audits
  • System Audits: Clinical Research, Medical Affairs
  • Bioavailability (BA) I Bioequivalence (BE) Facility Audits (GCP & GLP)
  • Vendor Evaluations
  • Contract Research Organizations (CROs)
  • Academic Research Organizations (AROs)
DR. ANU V. SHARMA, M. Pharm., Ph.D. (BHU), FIC – Drug Regulatory Affairs Expert
Dr. Sharma has worked in the area of Formulation Development and Regulatory affairs for more than 20 years in few top pharmaceutical companies like Cadila, Alembic, Core Healthcare, Claris, Marksans Pharma, Strides, Himalaya.
During this period , he developed several formulations & their Quality specifications for Domestic as well as Export markets covering various dosage forms like, Tablet, Capsules, Softgel capsules, Oral Powders, Liquid Orals, Gels, Injectables ( SVP/LVP including Oncology products, Parenteral Nutrition Products), dietary supplements ( Herbal formulations and Non-Herbal Formulations). He is well versed with the ICH, API/Bulk drug DMF, ANDA, CTD, ACTD, etc., the Technical specifications and quality testing parameters for Active Pharmaceutical ( Bulk Drugs), Finish Product, packaging materials, etc. During this tenure, he also developed several Novel formulations and filed patents for the same.
In the last 15 years, he has successfully got registered more than 500 various pharmaceutical formulations to various regulatory authorities across the world , including US, EU, Russia, RoW, etc. and was part of several international client/Regulatory Authority audits for product development, quality specifications.
He has also worked in Technology Transfer, Analytical Method transfer from R&D to other testing Laboratories of the World and presently working as Assistant Vice President – New Product Development & Analytical Development with additional responsibilities of International Regulatory Affairs for Global Market including US, EU, RoW.
I have also been active trainer in the area of Basic Pharmacy for the Non-Pharmacy employees, ICH guidelines on Quality, Product Design & Development, cGMP, Dossier Preparation & Review.
DR A. PANDEY, PHARMACOVIGILANCE EXPERT
Dr. Pandey is qualified medical doctor. 11 years of experience in managing Healthcare, Life sciences, Pharmacovigilance process transition, operations, client interaction.
At present setting up the Pharmacovigilance process at Certifiedpvpro and working on pharmacovigilance quality at CRQA.
Dr. Pandey has extensive experience with Accenture as Deputy Manager and iGATE as Team Manager – Pharmacovigilance Operations. Worked as Domain expert/ SME –pharmacovigilance with Pfizer Inc. Her experience and skills includes :
  • Expertise in handling client facing situations.
  • Strong Project management and operations management skills.
  • Strong knowledge in maintaining quality systems to ensure the quality of processes and deliverables of both projects and services meet the expectations as per regulatory requirements
  • Validation lead for multiple projects.
  • Argus implementation boot camp training conducted by Oracle
  • Trained in Argus 7.0 safety application.
  • Knowledgeable in processes and tools pertaining to Pharmacovigilance (Argus, Aris G, Ag Exchange and CARES) based on COTS life cycle.
  • Knowledgeable in various regulatory guidelines like ICH guidelines, Good Clinical Practices, Good Documentation Practices and Code of Federal Regulations, Volume 9A etc.
  • Business Process development - Developed SOPs and SOW for the process
  • Functional testing (OQ/PQ) for ArisG safety suite.
  • Post execution QA lead for testing of PQ/OQ scripts of ArisG safety application and Ag Exchange suite.
  • Extensive exposure in managing drug safety operations in leading IT companies.
  • An effective communicator & competent subject matter expert with honed analytical, operational & organizational abilities.
What's New
CRQA is looking for
qualified and Independent
Pharmacvovigilance Auditor
- experience essential in
Pharmacovigilance Audits.
Interested Professionals
may apply to bd@crqa.in
CRQA is looking for
qualified and Independent
Pharmacvovigilance Auditor
- experience essential in
Pharmacovigilance Audits.
Interested Professionals
may apply to bd@crqa.in
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