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Hire Dr. Vamshi Krishna R.

India

USD 30 /hr

PhD Pharmaceutics | Injectable Drug Delivery, Nanocarriers & Lyophilized Formulations | Regulatory Writer

Profile Summary

I am a Pharmaceutical R&D Scientist (PhD in Pharmaceutics, BITS Pilani) with expertise in the development of injectable and peptide formulations, lyophilized and solution-based drug delivery systems, and drug–device combinations (pen devices and pre-filled syringes) for regulated markets including the US, Canada, and Australia. With over 9 years of experience in formulation development, scale-up, and regulatory documentation, I bring strong technical and scientific capabilities to support projects from early-stage development through technology transfer and submission. I have successfully worked on QbD-driven product development, pre-formulation, compatibility and stability studies, process optimization, and regulatory-compliant documentation. My expertise includes: Injectable drug delivery systems: peptides, lipid nanocarriers, microspheres, lyophilized formulations. Documentation & regulatory support: SOPs, development reports, stability protocols, CTD modules, dossiers. Tech transfer & scale-up: Lab-scale to exhibit batches, process validation, and troubleshooting. Scientific research & writing: Literature reviews, data analysis, and publication support (10+ peer-reviewed papers, multiple patents granted). QbD & risk assessment: DoE-based formulation optimization and identification of CPPs & CMAs. I have hands-on experience with analytical and pre-formulation tools such as HPLC, DSC, FTIR, UV spectrometry, rheology, Franz diffusion studies, and software like GraphPad, Design Expert, PK Solver. Whether you require end-to-end support in formulation development, regulatory documentation, or scientific consulting for troubleshooting and scale-up, I can deliver precise, reliable, and high-quality outputs aligned with international standards. Let’s collaborate to accelerate your pharmaceutical development projects with scientific rigor and regulatory compliance.

Subject Matter Expertise

• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Small Molecule Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Drug Substance Characterization
• ☆ Drug Stability Testing
• ☆ Preclinical ADME/PK/PD
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ Preclinical Pharmacology
• ☆ In vitro Preclinical Toxciology
• ☆ In vivo Preclinical Toxicology
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Drug Efficacy Testing
• ☆ Bioavailability
• ☆ Rural Health
• ☆ Pharmaceutical Technology

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Non-Medical Regulatory Writing, Technical Writing, Copywriting, Creative Writing, Translation

Research User Research, Gap Analysis, Scientific and Technical Research, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Product Launch Support, Packaging Design

Work Experience

Research Scientist

Lupin Limited

August 2021 - July 2025

Education

PhD

Birla institute of technology sciences, pilani campus, pilani

August 2017 - July 2021

Certifications

• Certificate of Merit

  BITS Pilani

  January 2018 - Present

Publications

JOURNAL ARTICLE

Rapalli, V.K., Tomar, Y., Sharma, S., Roy, A., Singhvi, G.(2023). Apremilast loaded lyotropic liquid crystalline nanoparticles embedded hydrogel for improved permeation and skin retention: An effective approach for psoriasis treatment . Biomedicine and Pharmacotherapy. 162.

Stability indicating validated high‐performance liquid chromatography method for simultaneous estimation of chlorin e6 and curcumin in bulk and drug‐loaded lipidic nanoformulation <head> <META HTTP-EQUIV="Refresh" CONTENT="0;URL=/servlet/useragent"> </head> . SEPARATION SCIENCE PLUS.

Mahmood, A., Rapalli, V.K., Gorantla, S., Waghule, T., Singhvi, G.(2022). Dermatokinetic assessment of luliconazole-loaded nanostructured lipid carriers (NLCs) for topical delivery: QbD-driven design, optimization, and in vitro and ex vivo evaluations . Drug Delivery and Translational Research. 12. (5). p. 1118-1135.

Vamshi Krishna Rapalli, Arisha Mahmood, Tejashree Waghule, Srividya Gorantla, Sunil Kumar Dubey, Amit Alexander, Gautam Singhvi (2021). Revisiting techniques to evaluate drug permeation through skin . Expert Opinion on Drug Delivery.

Shantanu Damle, Manisha Choudhari, Gautam Singhvi, Ranendra Narayan Saha, Sunil Kumar Dubey(2021). Development and Validation of Reverse‐Phase High‐Performance Liquid Chromatography Method for Estimation of Itraconazole through Hydroxypropyl Methylcellulose Acetate Succinate based Polymeric Films using Quality by Design principles . SEPARATION SCIENCE PLUS. Wiley

Vamshi Krishna Rapalli, Swati Sharma, Aniruddha Roy, Gautam Singhvi (2021). Design and dermatokinetic evaluation of Apremilast loaded nanostructured lipid carriers embedded gel for topical delivery: A potential approach for improved permeation and prolong skin deposition . Colloids and Surfaces B: Biointerfaces.

Tejashree Waghule, Shalini Patil, Vamshi Krishna Rapalli, Vishal Girdhar, Srividya Gorantla, Sunil Kumar Dubey, Ranendra Narayan Saha, Gautam Singhvi(2021). Improved skin-permeated diclofenac-loaded lyotropic liquid crystal nanoparticles: QbD-driven industrial feasible process and assessment of skin deposition . Liquid Crystals. p. 1--19. Informa {UK} Limited

Vamshi Krishna Rapalli, Gautam Singhvi(2021). Dermato-pharmacokinetic: assessment tools for topically applied dosage forms . Expert Opinion on Drug Delivery. 18. (4). p. 423--426. Informa {UK} Limited

Rapalli, V.K., Sharma, S., Roy, A., Singhvi, G.(2021). Design and dermatokinetic evaluation of Apremilast loaded nanostructured lipid carriers embedded gel for topical delivery: A potential approach for improved permeation and prolong skin deposition . Colloids and Surfaces B: Biointerfaces. 206.

Waghule, T., Rapalli, V.K., Singhvi, G., Gorantla, S., Khosa, A., Dubey, S.K., Saha, R.N.(2021). Design of temozolomide-loaded proliposomes and lipid crystal nanoparticles with industrial feasible approaches: comparative assessment of drug loading, entrapment efficiency, and stability at plasma pH . Journal of Liposome Research. 31. (2). p. 158-168.

Dabholkar, N., Gorantla, S., Waghule, T., Rapalli, V.K., Kothuru, A., Goel, S., Singhvi, G.(2021). Biodegradable microneedles fabricated with carbohydrates and proteins: Revolutionary approach for transdermal drug delivery . International Journal of Biological Macromolecules. 170. p. 602-621.

Vyas, T., Rapalli, V.K., Chellappan, D.K., Dua, K., Dubey, S.K., Singhvi, G.(2021). Bacterial biofilms associated skin disorders: Pathogenesis, advanced pharmacotherapy and nanotechnology-based drug delivery systems as a treatment approach . Life Sciences. 287.

Gorantla, S., Dabholkar, N., Sharma, S., Rapalli, V.K., Alexander, A., Singhvi, G.(2021). Chitosan-based microneedles as a potential platform for drug delivery through the skin: Trends and regulatory aspects . International Journal of Biological Macromolecules. 184. p. 438-453.

Rapalli, V.K., Singhvi, G.(2021). Dermato-pharmacokinetic: assessment tools for topically applied dosage forms . Expert Opinion on Drug Delivery. 18. (4). p. 423-426.

Dabholkar, N., Waghule, T., Krishna Rapalli, V., Gorantla, S., Alexander, A., Narayan Saha, R., Singhvi, G.(2021). Lipid shell lipid nanocapsules as smart generation lipid nanocarriers . Journal of Molecular Liquids. 339.

Mahmood, A., Rapalli, V.K., Waghule, T., Gorantla, S., Singhvi, G.(2021). Luliconazole loaded lyotropic liquid crystalline nanoparticles for topical delivery: QbD driven optimization, in-vitro characterization and dermatokinetic assessment . Chemistry and Physics of Lipids. 234.

Dabholkar, N., Rapalli, V.K., Singhvi, G.(2021). Potential herbal constituents for psoriasis treatment as protective and effective therapy . Phytotherapy Research. 35. (5). p. 2429-2444.

Rapalli, V.K., Banerjee, S., Khan, S., Jha, P.N., Gupta, G., Dua, K., Hasnain, M.S., Nayak, A.K., Dubey, S.K., Singhvi, G.(2021). QbD-driven formulation development and evaluation of topical hydrogel containing ketoconazole loaded cubosomes . Materials Science and Engineering C. 119.

Rapalli, V.K., Mahmood, A., Waghule, T., Gorantla, S., Kumar Dubey, S., Alexander, A., Singhvi, G.(2021). Revisiting techniques to evaluate drug permeation through skin . Expert Opinion on Drug Delivery. 18. (12). p. 1829-1842.

Waghule, T., Dabholkar, N., Gorantla, S., Rapalli, V.K., Saha, R.N., Singhvi, G.(2021). Quality by design (QbD) in the formulation and optimization of liquid crystalline nanoparticles (LCNPs): A risk based industrial approach . Biomedicine and Pharmacotherapy. 141.

Rapalli, V.K., Sharma, S., Roy, A., Alexander, A., Singhvi, G.(2021). Solid lipid nanocarriers embedded hydrogel for topical delivery of apremilast: In-vitro, ex-vivo, dermatopharmacokinetic and anti-psoriatic evaluation . Journal of Drug Delivery Science and Technology. 63.

Waghule, T., Patil, S., Rapalli, V.K., Girdhar, V., Gorantla, S., Kumar Dubey, S., Saha, R.N., Singhvi, G.(2021). Improved skin-permeated diclofenac-loaded lyotropic liquid crystal nanoparticles: QbD-driven industrial feasible process and assessment of skin deposition . Liquid Crystals. 48. (7). p. 991-1009.

Tejashree Waghule, Vamshi Krishna Rapalli, Srividya Gorantla, Ranendra Narayan Saha, Sunil Kumar Dubey, Anu Puri, Gautam Singhvi(2020). Nanostructured Lipid Carriers as Potential Drug Delivery Systems for Skin Disorders . Current Pharmaceutical Design. 26. (36). p. 4569--4579. Bentham Science Publishers Ltd.

Vamshi Krishna Rapalli, Srividya Gorantla, Tejashree Waghule, Arisha Mahmood, Prem Prakash Singh, Sunil Kumar Dubey, Ranendra Narayan Saha, Gautam Singhvi(2020). Nanotherapies for the Treatment of Age-Related Macular Degeneration (AMD) Disease: Recent Advancements and Challenges . Recent Patents on Drug Delivery & Formulation. 13. (4). p. 283--290. Bentham Science Publishers Ltd.

Rapalli, V.K., Kaul, V., Waghule, T., Gorantla, S., Sharma, S., Roy, A., Dubey, S.K., Singhvi, G.(2020). Curcumin loaded nanostructured lipid carriers for enhanced skin retained topical delivery: optimization, scale-up, in-vitro characterization and assessment of ex-vivo skin deposition . European Journal of Pharmaceutical Sciences. 152.

Waghule, T., Sankar, S., Rapalli, V.K., Gorantla, S., Dubey, S.K., Chellappan, D.K., Dua, K., Singhvi, G.(2020). Emerging role of nanocarriers based topical delivery of anti-fungal agents in combating growing fungal infections . Dermatologic Therapy. 33. (6).

Waghule, T., Gorantla, S., Rapalli, V.K., Shah, P., Dubey, S.K., Saha, R.N., Singhvi, G.(2020). Emerging Trends in Topical Delivery of Curcumin Through Lipid Nanocarriers: Effectiveness in Skin Disorders . AAPS PharmSciTech. 21. (7).

Pradyuth, S., Rapalli, V.K., Gorantla, S., Waghule, T., Dubey, S.K., Singhvi, G.(2020). Insightful exploring of microRNAs in psoriasis and its targeted topical delivery . Dermatologic Therapy. 33. (6).

Rapalli, V.K., Waghule, T., Hans, N., Mahmood, A., Gorantla, S., Dubey, S.K., Singhvi, G.(2020). Insights of lyotropic liquid crystals in topical drug delivery for targeting various skin disorders . Journal of Molecular Liquids. 315.

Gorantla, S., Rapalli, V.K., Waghule, T., Singh, P.P., Dubey, S.K., Saha, R.N., Singhvi, G.(2020). Nanocarriers for ocular drug delivery: Current status and translational opportunity . RSC Advances. 10. (46). p. 27835-27855.

Waghule, T., Rapalli, V.K., Gorantla, S., Saha, R.N., Dubey, S.K., Puri, A., Singhvi, G.(2020). Nanostructured lipid carriers as potential drug delivery systems for skin disorders . Current Pharmaceutical Design. 26. (36). p. 4569-4579.

Rapalli, V.K., Waghule, T., Gorantla, S., Dubey, S.K., Saha, R.N., Singhvi, G.(2020). Psoriasis: pathological mechanisms, current pharmacological therapies, and emerging drug delivery systems . Drug Discovery Today. 25. (12). p. 2212-2226.

Gorantla, S., Singhvi, G., Rapalli, V.K., Waghule, T., Dubey, S.K., Saha, R.N.(2020). Targeted drug-delivery systems in the treatment of rheumatoid arthritis: Recent advancement and clinical status . Therapeutic Delivery. 11. (4). p. 269-284.

Rapalli, V.K., Kaul, V., Gorantla, S., Waghule, T., Dubey, S.K., Pandey, M.M., Singhvi, G.(2020). UV Spectrophotometric method for characterization of curcumin loaded nanostructured lipid nanocarriers in simulated conditions: Method development, in-vitro and ex-vivo applications in topical delivery . Spectrochimica Acta - Part A: Molecular and Biomolecular Spectroscopy. 224.

Mahmood, A., Rapalli, V.K., Waghule, T., Gorantla, S., Dubey, S.K., Saha, R.N., Singhvi, G.(2020). UV spectrophotometric method for simultaneous estimation of betamethasone valerate and tazarotene with absorption factor method: Application for in-vitro and ex-vivo characterization of lipidic nanocarriers for topical delivery . Spectrochimica Acta - Part A: Molecular and Biomolecular Spectroscopy. 235.

Vamshi Krishna Rapalli, Gautam Singhvi, Srividya Gorantla, Tejashree Waghule, Sunil Kumar Dubey, Ranendra Narayan Saha, Md Saquib Hasnain, Amit Kumar Nayak(2019). Stability indicating liquid chromatographic method for simultaneous quantification of betamethasone valerate and tazarotene in in vitro and ex vivo studies of complex nanoformulation . Journal of Separation Science. 42. (22). p. 3413--3420. Wiley

Dua, K., Wadhwa, R., Singhvi, G., Rapalli, V., Shukla, S.D., Shastri, M.D., Gupta, G., Satija, S., Mehta, M., Khurana, N., et al.(2019). The potential of siRNA based drug delivery in respiratory disorders: Recent advances and progress . Drug Development Research. 80. (6). p. 714-730.

Waghule, T., Rapalli, V.K., Singhvi, G., Manchanda, P., Hans, N., Dubey, S.K., Hasnain, M.S., Nayak, A.K.(2019). Voriconazole loaded nanostructured lipid carriers based topical delivery system: QbD based designing, characterization, in-vitro and ex-vivo evaluation . Journal of Drug Delivery Science and Technology. 52. p. 303-315.

Rapalli, V.K., Singhvi, G., Gorantla, S., Waghule, T., Dubey, S.K., Saha, R.N., Hasnain, M.S., Nayak, A.K.(2019). Stability indicating liquid chromatographic method for simultaneous quantification of betamethasone valerate and tazarotene in in vitro and ex vivo studies of complex nanoformulation . Journal of Separation Science. 42. (22). p. 3413-3420.

Gorantla, S., Waghule, T., Rapalli, V.K., Singh, P.P., Dubey, S.K., Saha, R.N., Singhvi, G.(2019). Advanced hydrogels based drug delivery systems for ophthalmic delivery . Recent Patents on Drug Delivery and Formulation. 13. (4). p. 291-300.

Jain, S., Cherukupalli, S.K., Mahmood, A., Gorantla, S., Rapalli, V.K., Dubey, S.K., Singhvi, G.(2019). Emerging nanoparticulate systems: Preparation techniques and stimuli responsive release characteristics . Journal of Applied Pharmaceutical Science. 9. (8). p. 130-143.

Rapalli, V.K., Gorantla, S., Waghule, T., Mahmood, A., Singh, P.P., Dubey, S.K., Saha, R.N., Singhvi, G.(2019). Nanotherapies for the treatment of age-related macular degeneration (Amd) disease: Recent advancements and challenges . Recent Patents on Drug Delivery and Formulation. 13. (4). p. 283-290.

Rapalli, V.K., Singhvi, G., Dubey, S.K., Gupta, G., Chellappan, D.K., Dua, K.(2018). Emerging landscape in psoriasis management: From topical application to targeting biomolecules . Biomedicine and Pharmacotherapy. 106. p. 707-713.

Singhvi, G., Manchanda, P., Krishna Rapalli, V., Kumar Dubey, S., Gupta, G., Dua, K.(2018). MicroRNAs as biological regulators in skin disorders . Biomedicine and Pharmacotherapy. 108. p. 996-1004.

Dua, K., Rapalli, V.K., Shukla, S.D., Singhvi, G., Shastri, M.D., Chellappan, D.K., Satija, S., Mehta, M., Gulati, M., Pinto, T.D.J.A., et al.(2018). Multi-drug resistant Mycobacterium tuberculosis &amp; oxidative stress complexity: Emerging need for novel drug delivery approaches . Biomedicine and Pharmacotherapy. 107. p. 1218-1229.

BOOK CHAPTER

Vyas, T., Gorantla, S., Waghule, T., Rapalli, V.K., Singhvi, G.(2022). Solid-Lipid Nanocarriers (SLNs)-Based Drug Delivery for Treating Various Pulmonary Diseases . Advanced Drug Delivery Strategies for Targeting Chronic Inflammatory Lung Diseases. p. 259-280.

Singhvi, G., Rapalli, V.K., Waghule, T., Gorantla, S., Pemmadi, R.V., Patel, R., Dubey, S.K.(2020). Microparticulate drug delivery systems for targeting respiratory diseases . Targeting Chronic Inflammatory Lung Diseases Using Advanced Drug Delivery Systems. p. 337-357.

Singhvi, G., Hejmady, S., Rapalli, V.K., Dubey, S.K., Dubey, S.(2020). Nanocarriers for topical delivery in psoriasis . Delivery of Drugs: Volume 2: Expectations and Realities of Multifunctional Drug Delivery Systems. p. 75-96.

Rapalli, V.K., Khosa, A., Singhvi, G., Girdhar, V., Jain, R., Dubey, S.K.(2019). Application of QbD Principles in Nanocarrier-Based Drug Delivery Systems . Pharmaceutical Quality by Design: Principles and Applications. p. 255-296.