Our Teams and
Associate
Jitendra Pandey Founder & Director
- Jitendra is the visionary founder of Suktas Organic and Lifescience Private Limited, dedicated to expanding the company’s global reach with a dynamic portfolio. With a robust background in engineering and extensive experience in the pharmaceutical industry, he is a seasoned professional renowned for his expertise.
- Holding a Bachelor’s degree in Mechanical Engineering from REC Bhalki, Karnataka, Mr. Pandey specializes in facility design, utility systems, and project execution, including both greenfield and renovation projects for sterile and non-sterile drug products and cosmetics.
- Jitendra’s career spans over 16 years, during which he has garnered significant industrial experience both locally and internationally. His role has included not only corporate sector engagements but also consultancy within the pharmaceutical engineering field. His profound knowledge and experience in this domain, combined with a distinctive skill set, set him apart as a leader in his field.
- Notable projects under his belt include collaborations with major industry players such as Ankus Drugs Limited, Ranbaxy, Gufic Lifescience Limited, Umedica Laboratories Private Limited, Bal Pharma Limited, Ajanta Pharma Limited, Zydus Takeda, and Emcure Limited.
Expert in
- Quality risk management Project management
- Project quality management Pharmaceutical quality system
- Inspection Audit Compliance training
- Engineering Detailed Design
- Front End Engineering
- Detailed Engineering
- Procurement Assistance
- Project & Construction Management
- Trunkey projects
DIVYA SINGH, DIRECTOR
- Divya is a seasoned Quality Assurance professional with 16 years of industry experience, specializing in global cGMP audits and vendor qualification. Her expertise encompasses both non-sterile and sterile APIs, non-sterile and sterile finished dosage forms (FDFs), API starting materials, excipients, and primary packaging materials.
- Divya excels in facilitating strategic business decisions with a focus on quality, compliance, and lean qualification. She ensures the implementation of cGMP requirements in alignment with USFDA 21 CFR Part 211 & 212, European Commission standards, PIC/S guidelines, and WHO regulations.
- She holds a Master’s Degree in Microbiology from Acharya Natarajan University, Andhra Pradesh, and a second post-graduation degree, M.Tech in Quality Management from BITS, Pilani, Rajasthan.
- Since 2019, Divya has been an IAQC member at St. John Pharmacy College, Mumbai. Her professional experience includes working on greenfield projects for Farmson Analgesics at Farmson Pharmaceuticals, Gufic Lifesciences Private Limited, and engineering projects at Zydus Healthcare Limited. She has audited over 50 sites, including major USFDA-approved facilities across India such as Zydus Healthcare Limited, Vasudha Pharmachem Limited, IPCA Laboratories Limited, Aarti Drugs Limited, and ACG Group.
Regulatory Audit Exposure:
WHO – India, USFDA, EU GMP, MOH Ukraine, NDA Uganda, PPB-Kenya, TMDA Tanzania, MOH-Ethiopia
Expertise in:
- She has also worked to lift the suspension of drug products from Panama, Ministry of Health by visiting the Director of the Panama Health Authority, the Director of Instituto de Analisis de Expertos (IEA), and Vise Health Minister of Panama.
- Microbiological Techniques
- Quality management system implementation & Project quality management
- Validation of process, cleaning method, and area.
- 21 CFR part 211 & 212
DR. DEBARSHI KAR MAHAPATRA, DIRECTOR
- Dr. Debarshi stands out as a distinguished academic person among the pharmaceutical industry professionals, thereby bringing a strong academic background to complement his extensive experience in the Industry/Consultancy interface.
- He is Ph.D. in Pharmaceutical Chemistry from Dr. Hari Singh Gour Vishwavidyalaya (A Central University), Sagar (M.P.) and having 10+ years of teaching experience and over a decade of academic research expertise.
- He has been listed among the Top 2% of International Scientists by Stanford University, USA, for the years 2020, 2021, 2022, and 2023, and received the esteemed Young Investigator Award from India and Southeast Asia in 2016 from the Bill and Melinda Gates Foundation, USA, presented by the International Society for Infectious Diseases (ISID).
- Currently, Dr. Mahapatra serves as an approved reviewer for over 100 journals, having reviewed more than 1000 manuscripts. He is actively involved as an Editorial Board Member, Section Editor, and Academic Editor for several renowned international journals.
- Dr. Mahapatra holds three Indian Patents for his work on low-molecular-weight ligands. He is a member of various professional and international scientific societies and is recognized as a Health Columnist for Gyan Vitaranam, a popular youth magazine in India. He also serves as Vice President for the Expert Pharmacy Association in Haryana.
- He has imparted knowledge in Medicinal Chemistry and Computational Chemistry at both undergraduate and postgraduate levels, mentoring numerous students in diverse research projects.
About our Team & Associates:
Our strength is strategic collaborations with our business partners to get Collaborative support from firms:
- PharmaXL
- PharmaD
- Genexis Biotech
- Uranus Laboratories
Team:
- A team of 18 competent Engineers to support for Greenfield project.
- Collaborative support from a group of 30 GxP experts to support Aseptic practices, Engineering clean rooms, Gap analysis & Due-diligence audit, Deployment of QMS & GLP, Investigation, RCA & Impact, CAPA, Remediation and Quality culture, etc.
- On-demand and customized support from the veteran retired Experts from USFDA and EU regulatory bodies to address prevailing regulatory issues.
- We leverage flexible agile talent for the project, advisory roles, and part-time resources to meet your Organization’s goals.
- An integrated approach with close monitoring and hand-holding that covers the complete product lifecycle, providing sustainable solutions to the compliance, business, and regulatory risks at Indian price.
KANDA KUMAR
Founder & Principal Consultant, Pharm D
- With 25+ years of experience in Pharmaceutical Engineering, He is an accomplished Chemical Engineer and Pharmacist. Specializes in Pharmaceutical – Formulation (sterile and non-sterile) and API plants.
- He has done 44+ successful projects within the company and more than 98+ projects in 25+ years span.
- For USFDA, EU-GMP, PIC/S, WHO, etc. adhering to regulation standards.
- His extensive background and global experience make him a leading expert in the field of pharmaceutical engineering consulting.
- His areas of expertise are:
- Front End Engineering including Site Master Planning, Conceptual Design Development, cGMP Layout, cGMP & EHS Risk Assessment, Containment Strategies, General Planning & Engineering, Equipment Sizing, Production Capacity Planning, and Basis of Design.
- Detailed Engineering includes Tender Documents for Architectural, Civil, Structural, Process, Mechanical, HVAC, Piping, Modular Panels/Clean Rooms, Electrical, Instrumentation, BMS, EMS, Fire Fighting, Clean Utilities, Black Utilities, Warehouse, and QA/QC. Bill of Quantity, Revit 3D Design on BIM Platform, Technical Data Sheets, Technical Specifications, Approved Makes List, Good for Construction Drawings.
- Procurement Assistance includes Vendor Selection for Equipment & Contracts, Floating of Enquiry and Tender Documents, Follow up for proposals, Technical Evaluation, Techno-Commercial Comparison, and Technical Recommendation of suitable vendors.
- Project & Construction Management includes Project Scheduling, Project Tracking, Project Weekly Report, Project Co-ordination, MIS Report, Periodic Meetings with Clients and Vendors, Site Supervision, Bill Certification, Monitoring Site Issues, Controlling & monitoring of SHE Practices, Site Installation & Erection.
- Trunkey projects for end-to-end solutions for pharmaceutical manufacturing setup.
BHAV SARASWAT
- He has completed M. Pharm. in pharmaceuticals and owned Uranus Laboratories.
- He has 10+ years of experience and expertise in pharmaceutical product development and technology transfer to derive the critical quality attributes, critical process parameters, and tolerances within the GMP framework and scale up development to reproducible method and process technology transfer of product as per the current guidelines following QbD and QRM approaches.
- He has worked on more than 20 product profiles deriving CQA, CPP, and Design space – NCE, API, IND, ANDA which includes oral dosage forms and subject matter expert in API pellet manufacturing.
