Ramakant Panda

An accomplished research and development specialist with 22 years of experience in pharmaceutical formulation R&D and Technology transfer of diversified dosage forms, aspiring for a career that places me in a challenging position within a fast-paced and learning-oriented environment where I can utilize skill and creatively involved with a system that effectively contributes to the growth of organization.

• Good level of scientific and project handling skills in early and late-stage development.
• Expertise in drug product development and technology transfer of diversified pharmaceutical dosage forms (Solid oral, liquid oral, semisolid, Soft gel and sterile dosage forms) for Regulated & Emerging markets US, EU, ROW, and global regulatory agencies WHO, UNICEF.
• Well-versed with the regulatory guidelines and requirements for the development, process mapping, scale up and technology transfer of solid oral, liquid oral, sterile, and Topical dosage forms.
• Hands on experience in the area of process mapping, process DoE, IVIVC/IVIVR, PAT, Risk assessment, trouble shooting and process improvement.
• Well versed with the CMC requirement of SUPAC, PAS, CBE-30 and Variation filing
• Good level of process improvement skills to improve COGS and % TPT
• Skilled troubleshooter
• Good experience of GxP
• Proven ability to manage, lead and motivate team members
• Audit exposure: USFDA, EU-GMP, WHO, PHFDA, TMDA and NPRA
• Excellent verbal and written communicator

• Successful development, product approval and commercialization of 60+ products with RFT > 95 % for different markets /agencies
• S. No Market/Agencies Product category No of products
• 01 USFDA/PEPFAR ARVs, Immunosuppressant, Anti-infectives, anti-parkinsonism, anti-hyperparathyroidism 10
• 02 EMA Anti-anginal, Anti-diabetic, Multiple sclerosis, Anti-inflammatory 15
• 03 WHO/UNICEF /ROW Anti-malarial, Anti-diarrheal, Anti-Tubercular, Antibiotics, Anti-Anginal, Anti-infective –Antibacterial, Anti-diabetic, Antihypertensive 15
• 04 CDSCO (India) Multiple/diverse category 29

• New product selection in coordination with the Business Development (BD) team
• Leading products and process from concept to exhibit and regulatory approval through the development & execution of generic bioequivalent formulations in line with ICH and QbD principles.
• Technology transfer plan for new and existing products to achieve new product submission interfacing with Project management, CMC team, RA and QA with adherence to timelines.
• Providing scientific and technical direction for scale up, technology transfer, process validation of drug product to achieve product submission and commercial launch.
• Ensure and support QbD process risk assessment and mitigation plan with First time Right (FTR) approach from technical scale up through process validation and commercial supply to achieve a robust and reproducible manufacturing process.
• Planning and execution of continued process verification
• Lead trouble shooting and root cause analysis (RCA) using available best in class scientific approaches to address Challenges faced during product life cycle.
• Review and approve protocols, reports, BMRs, BPRs, sampling plans, validation plans and other technical documents to achieve compliance to quality system
• Alternate vendor development (AVD) to meet the continuous demand of materials for production and cost competitiveness
• Support team deliverable including plan, site operations to meet defined timelines.
• Coaching, Mentoring, and Team Building to develop a deep expertise and solution-oriented mindset for various technical problems.
• Represent and collaborate with relevant global forums / stake holders to follow best practice in industry related to pharmaceutical technology.
• Ensuring proper implementation of Good Documentation Practices (GDP) for Laboratory journals, Technology transfer documents, process validation reports and Product development reports (PDR)
• Operating Network
• Internal: Business development (BD), Formulation and Analytical Team, Purchase, Manufacturing Team, QA, QC CMC and Regulatory Affair.
• External: RM/PM/Equipment Vendors, Clinical Research Organization (CROs), CMOs

• DOSAGE FORMS
• SOLID ORAL Tablets (IR, MR, ODT) Capsule (Hard gelatin)
• LIQUID ORAL Solution, suspension & Emulsion
• SOFT GELATIN
• SEMI SOLID Gel, Emulgel, Creams and ointment
• STERILE / INJECTABLES
• TECHNOLOGY PLATFORM
• FBP GRANULATION/DRUG LAYERING (TOP & BOTTOM SPRAY)
• HIGH SHEAR GRANULATION
• DRY GRANULATION (RC)
• ODT PLATFORMS
• SUSTAINED RELEASE POLYMER MATRIX
• SMEDS /SNEDDS
• SOLID DISPERSION (ASD)
• DEVELOPMENT TOOLS
• QbD, DoE
• PAT
• RISK ASSESSMENT/FMEA
• IVIVR/IVIVC
• REGULATORY
• EMA: CP, DCP, MRP
• USFDA: (Para-III/ IV (NIF) PEPFAR
• ROW: CIS, ASEAN, GCC, LATAM, EAST & WEST AFRICA
• WHO, UNICEF
• CDSCO (India)
• AUDIT EXPOSURE: USFDA, EU-GMP, PHFDA, TMDA, NPRA

• Presented an oral paper on the topic “Anti-neoplastic agents” at National Conference of Pharmacy Students (PHARMACON-2000) organized by Department of Pharmaceutical Sciences, College of Engineering, Andhra University, Visakhapatnam.
• Various training and presentations on QbD, DOE and IVIVC

• PANDA, R., & LANKALAPALLI, S. (2025). Bioavailability Enhancement and Polymorphic Stabilization of One BCS Class IV Metastable Drug Through Novel Formulation Approach. Turkish Journal of Pharmaceutical Sciences, 22(5), 333-348. https://doi.org/10.4274/tjps.galenos.2025.89956 (Scopus)
• Panda, R., & Lankalapalli, S. (2023). Design of experiments and optimization of amorphous solid dispersion of a bcs class iv anti platelet drug through factorial design. International Journal of Applied Pharmaceutics, 15(6). https://doi.org/10.22159/ijap.2023v15i6.48767(Scopus)
• Ramakant Panda, Srinivas Lankalapalli. Development and validation of a discriminatory dissolution method for amorphous solid dispersion formulation of polymorphic Artemether. Research Journal of Pharmacy and Technology. 2023; 16(11):5303-8. 10.52711/0974-360X.2023.00859 (Scopus)
• Panda, ramakant. “Bio Availability and Polymorphic Stability Challenges Affecting Drug Product’s Potential:A Critical Evaluation and Pertinent Solution”. Asian Journal of Pharmaceutical and Clinical Research, vol. 16, no. 11, June 2023, https://journals.innovareacademics.in/index.php/ajpcr/article/view/48177 (Scopus/Embase)

• Rachna, Kumria, Dr (Mrs), +91 76809 96745, Pfizer, Quality Head
• Akash, Mathur, Dr, +91 82962 44777, Stellence Pharma Sc Ltd, CEO and ED, Ex- CEO, Bal Pharma Ltd