II PHARMA II BIOTECH II MEDICAL DEVICE II
About me
Qualified Pharmacist with over 27 years of Industry experience in Finished dose Formulation/ API/ Biotech/ Medical Device in advanced / regulated markets worldwide
Expertise across Quality (QA/QC/RA), Projects, Validation, Manufacturing
First Class Degree in Pharmacy from Utkal University
Certified lead auditor for ISO 13485 (QMS of Medical Device) from BSI
Certification program by Indian Institute of Management, Bangalore (IIM-B) - “People Management’ (HR 101X)
2018 –2023 : Vice President Corporate Quality for Schott Poonawalla, India, A Medical Device (Syringe, Cartridge & Vial) manufacturing company, responsible for set up and operation of the greenfield site catering to all regulated / advanced markets including US, EU , Canada, Aus/NZ, SEA, Africa & Japan
2016-2018 : Director Quality for Dr Reddy’s, ranked Top 5 in India, responsible for Quality for two units catering to Oncology /Potent molecules (OSD&Injectable) & Speciality Injectables
2011 –2016 : Head Quality for Naprod Life Sciences/ MacChem, India in Formulation & API for Oncology & General range, spearheading their quality and transforming it from a CMO to regulated environment
2009 –2011: Heading Quality for Macleods, India catering to Regulated markets, WHO prequalification & exporting to more than 50 countries
1997 –2009 : Worked over a decade in various capacities in Pharma Companies in India like Ranbaxy, Wockhardt, Fresenius, Sun Pharma & MJ Biopharm. Also worked in Africa for Dana Pharma (Nigeria) & in Middle East (Oman) for Oman Pharma
DRx Debashish Panda, B. Pharm, R. Ph.
Founder & Lead Consultant
DP GxP Consulting
Expert Consulting
Specializing in pharma, biotech, and medical device technical advisory.
Providing Expert Consulting Services in Quality Management, Regulatory, Compliance, Projects, Design & Development, Sterile / Aseptic operations and Validation.
Expert Consulting Services
Our consulting services are designed to provide end-to-end support across various critical areas in the pharmaceutical and medical device industries. From regulatory compliance to quality assurance, we help streamline processes and ensure alignment with global standards. Our services are built on decades of expertise and a deep understanding of both industry needs and regulatory landscapes.
Quality Assurance Solutions
We provide robust quality assurance solutions tailored to meet stringent industry standards, including GMP, ISO certifications, and regulatory guidelines. Our expertise spans quality control labs, sterile and non-sterile operations, and risk management strategies. We help you implement and optimize your quality management systems to maintain compliance and enhance product quality across the entire manufacturing process.
Regulatory Compliance Support
We offer expert guidance on regulatory frameworks, ensuring that your pharmaceutical products and medical devices meet all local and international regulatory standards. From US FDA to EMA and ISO certifications, our in-depth understanding of compliance requirements for various regions helps clients avoid costly delays and rejections. Our services include dossier preparation, product registration, and comprehensive support for filings like 510(K), CE Marking, and more.
Services
Providing specialized advice in pharma, biotech, and medical devices.
Quality Management
We provide comprehensive quality management services, including gap assessments, audits, and compliance support to ensure your sites meet international regulatory standards like US FDA, UK MHRA, EMA, and others.
Regulatory / Product Registration
Our regulatory services guide you through product registrations and certifications across global markets, including US FDA filings, EU MDR compliance, ISO certifications, and drug-device combination approvals.
Project / Validation Services
From facility design to process validation, we manage every step of your project, ensuring compliance with regulatory requirements and optimizing processes for efficient operations.
Sterilization & Audit Services
We offer sterilization process expertise and conduct independent audits of suppliers, labs, and manufacturers to ensure compliance with industry standards and sterility assurance.
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Expert Services
With extensive knowledge and expertise in various domains of the pharmaceutical industry, our team offers a range of services designed to meet the needs of both regulatory compliance and operational excellence. We are specialized in providing tailored solutions that ensure high-quality standards and successful project execution.
Experience
Specialized Technical Expertise
Our subject matter experts (SMEs) have deep expertise across multiple areas including:
Pharmaceutical Formulations: Covering General, Potent, Hormone, Steroid, Oncology, Insulin, Antibiotic (Cepha, Penems, Beta Lactams), and Sterile formulations (Parenteral, Ophthalmic).
Sterile Formulations: Expertise in sterile products including injections (solutions, suspensions, emulsions), lyophilization, and lotions/creams.
Oral Solid Dosage Forms: Comprehensive knowledge of tablets, capsules (IR/MR/DR), and soft/hard gelatin capsules.
Topical and Semi-Solid Preparations: Developing ointments, creams, lotions for both sterile and non-sterile applications.
Biotechnology and Biologicals: Proficiency in insulin (human, bovine, porcine), biosimilars, vaccines, and amino acids.
Dedicated to Excellence
Our commitment to excellence is evident in every project, from regulatory approvals to cutting-edge technology transfers. With hands-on experience in managing sterile operations, medical device production, and complex manufacturing processes, we deliver results that adhere to international standards. Our approach guarantees compliance with agencies such as the US FDA, EMA, and WHO, ensuring that your projects meet all required benchmarks for quality and safety.
Expert Technical Advisory in Pharma, Biotech & Medical Device
DRx Debashish Panda, R.Ph. offers unparalleled expertise in pharmaceuticals, biotechnology, and medical devices, ensuring quality assurance, regulatory compliance, and effective risk management for your projects. Proven experience in serving clients across India & globally with channel / service partners / experts.
150+ Projects
25+ Clients
Trusted by Industry
Proven Results
Expert Technical Advisors in Pharma and Biotech
At DP GXP Consulting, we specialize in providing expert technical advisory services in pharmaceuticals, biotechnology, and medical devices, ensuring compliance and quality assurance across various domains.
"Highly knowledgeable and professional team."
DRx Debashish Panda, R. Ph.
Enquiry
For expert advice on pharma, biotech, and medical devices, reach out to DRx Debashish Panda.
Contact Us
For expert advice in pharma, biotech, and medical devices, reach out to Dr. Debashish Panda, R. Ph. today.
Location
Hours
9 AM - 6 PM
Debashish.Panda@DPGxPConsulting.com
+91 9823056343
Office/ Workplaces at Daman (UT) & Boisar, Mumbai Sub-Urban, Maharashtra, India.
Registered Office/ Workplace -1 G1, Radhika, SaiKripaSociety-2, Mashal Chowk, Nani Daman, Daman & Diu (UT), India, 396 210.
Office/ Workplace -2 F-5/B-10, ShivGovindNagar, AmeyaPark, Boisar, Maharashtra, India, 401 501.
