Leadership
Masuu Global’s leadership team brings together global pharma regulatory and quality expertise, cutting-edge software solutions, and operational excellence. We are committed to building lasting and meaningful relationships with our clients through a collaborative and transparent approach.
Dr. Ramesh Pennamareddy
Founder and Managing DirectorDr. Ramesh brings over 20 years of expertise in the pharmaceutical industry and his extensive experience spans analytical, quality, R&D operations, and regulatory affairs.
Dr. Pennamareddy has held senior positions at renowned pharmaceutical companies such as Glenmark, Amneal, and Chemo (Insud Group). He has played a crucial role in regulatory submissions and securing approvals for both generic and innovative products for the US, EU and global market. His achievements include numerous First-to-File (FTF), First-to-Market (FTM), PFC, and CGT designated complex sterile and ophthalmic suspensions, as well as drug-device combination products.
Dr. Pennamareddy earned his Master’s degree in Microbiology from Nagarjuna University and his Ph.D. in Life Sciences from Bharathidasan University. He is also an active member of various pharmaceutical associations, contributing to the industry’s growth and innovation.
Mrs. Swarna Priya Pennamareddy
Founder and Chief Executive OfficerMrs. Swarna brings decade of experience with a strong background in regulatory operations and technologies. She leads the technical and development teams to deliver top-tier pharmaceutical software and solutions.
She is responsible for Financial Planning & Analysis (FP&A), Information Technology, and overall facility administration. Her expertise spans several business functions, including strategic planning, operations, project management, business development, and after-sales support.
Swarna Priya playing a key role in establishing and managing the overall operations at Masuu Global Solutions.
She holds a B. Tech in Computer Science from Jawaharlal Nehru Technological University.
Dr. Muralidhara Babu Gavini
Director, USA Office, Quality and AuditDr. Murali (Mike) Gavini is the USA Director of Masuu Global Solutions, bringing 40 years of experience. Prior to joining Masuu Global, he served as a USFDA Auditor – Compliance & Investigational for over 17 years.
As a USFDA Compliance Officer, Dr. Gavini reviewed establishment inspection reports for API, Analytical Labs, and Finished Dosage manufacturer. He also served as the Senior Assistant Country Director for the USFDA Office of International Programs, working in Mumbai for 5 years, where he inspected over 75 Drug Product and API Manufacturers, leading to several regulatory actions.
Dr. Gavini has received advanced training in Pharmaceutical Inspectorate (PI) and Process Analytical Technologies (PAT) and is certified as a Level-II investigator. He holds a Master’s degree in Chemistry from Andhra University and a Ph.D. in Chemistry from the University of Arkansas.
Dr. Khemraj Hirani
Chief Regulatory Officer, Masuu Global LLC, USADr. Khemraj (Raj) Hirani, with an illustrious career bridging continents from India, Japan, Europe and United States. He is a luminary in the international pharmaceutical and clinical research arena.
Dr. Raj role as an FDA Form 1572 investigator for over 30+ clinical trials, and his tenure as the Lead Investigational Pharmacist in Oncology and Hematology, highlight his direct involvement in the advancement of medical therapies. Dr. Hirani’s expertise extends across a broad spectrum of therapeutic areas including endocrinology, diabetes, metabolism, neurology, cardiology, and pediatric drug development, alongside his contributions to novel product development in improving ambulatory services and treatments for pulmonary diseases.
Dr. Hirani’s global experience is evident in his role as a Director Clinical Operations & Regulatory Agent at Massu Global, where he adeptly navigates complex regulatory landscapes. His entrepreneurial spirit shines as the scientific co-founder of PriZm Therapeutics and as a seed investor in iTolerance Inc. His advisory positions at Rancho Santa Fe Bio Inc, Creative Medical Technology Holdings Inc, Ambulero Inc, and Abbreos Inc demonstrate his pivotal role in steering these companies through regulatory due diligence and market approval processes.
His journey began at the esteemed College of Pharmaceutical Sciences, Manipal, India, where he emerged as a valedictorian, laying a solid foundation with a Bachelor of Pharmacy, and PhD in Pharmacology at Nagpur University, India. Furthering his credentials, Dr. Hirani acquired an MBA from the Indian Institute of Modern Management, Pune, blending scientific prowess with business acumen. Dr. Raj also holds degrees including RPH, RAC, CIP, CCRP, and an MBA from esteemed institutions.
Mr. Shiv Kumar Somani
Director, Operations and TechnicalMr. Shiv Somani brings over 11 years of extensive experience in Business Operations, Business Development, Project Management, eCTD Publishing, and eLabeling. Throughout his career, he has worked with the renowned pharmaceutical companies like Amneal and Pfizer.
Mr. Shiv plays a pivotal role in providing strategic and operational guidance to teams on regulatory and technical matters related to the submissions. He is also one of the visionary behind the development and implementation of pharma software like NextGen eCTD, SPL, and PDF Plugin, which are integral tools for global regulatory submissions.
He holds a Master’s degree in Pharmacy, specializing in Pharmaceutical Management and Regulatory Affairs, from Lachoo College of Pharmacy.
Scientific Advisory Board Members
Mr. Concepción “Coki” Cruz
Former USFDA GMP InspectorMr. Coki is a seasoned pharmaceutical expert, boasting over 40 years of extensive experience in regulatory inspections, investigations and compliance. He has conducted over 100+ regulatory and compliance USFDA inspections/audits globally.
Mr. Coki’s served on multiple senior positions in the USFDA for more than 30 years from Office of Regulatory Affairs to CDER/Office of Pharmaceutical Quality, in his position as Division Supervisor, Division of Quality Intelligence.
Mr. Coki holds an MSc in Regulatory Affairs / Quality Assurance and BSc in Chemistry. He was an FDA / ORA Drug Program Trainer, an International Drug Inspections Cadre Member, and an FDA Leadership Development Program Graduate.
Mr. Akhilesh Khale
Former TGA GMP InspectorMr. Akhilesh Khale is a seasoned pharmaceutical expert, boasting over 35 years of extensive experience in inspections, investigations, regulatory, and compliance. He conducted over 100 regulatory and compliance TGA (Therapeutic Goods Administration) inspections/audits globally.
Mr. Akhilesh served in multiple senior positions in the pharmaceuticals, medical devices, and biotech industry including vaccines for more than 25 years at renowned companies like Sentiss Pharma, Mankind Pharma, and Sun Pharma Industries.
Mr. Khale holds an M. Sc. in Microbiology with diplomas in Government Investigations, Quality Auditing, International Affairs, and Diplomacy. He is certified as a Master Auditor for ISO 9001:2015, Lead Auditor for Risk Management (ISO 14971 & ISO 31000), and Medical Devices ISO 13485:2016.
Dr. Walid Smadi
CEO W.S Marketing Consulting EstDr. Walid is a seasoned pharmaceutical expert, boasting over 40 years of extensive experience spanning from Research and Development to successful product launches across the GCC, MENA, and North African regions. His operational proficiency in clinical, regulatory affairs, marketing and manufacturing was exemplary.
Dr. Walid has played pivotal roles in renowned companies such as Novartis, Schering Plough, ACPC, MID Pharma, and Pharma Consulting Group, where he spearheaded various strategic initiatives with remarkable success and additionally, he is a member of both the Jordan Pharmaceutical and the Jordan Businessmen Association.
Dr. Walid holds a Doctorate Degree in Pharmacy (Excellent with Honor Degree).
Mr. Harvey Jaramillo
Former Regulatory Technician at INVIMAMr. Harvey Jaramillo is a seasoned pharmaceutical expert, boasting over 14+ years of extensive experience in Regulatory Affairs and skilled in managing diverse portfolios encompassing innovative therapies, and established products, specializing in the Latin American Region.
Mr. Harvey had notable achievements including representing organizations before MoH in Colombia (INVIMA Health Authority of Colombia), Ecuador, and Peru, showcasing adeptness in navigating complex regulatory landscapes. He has played pivotal roles in renowned companies such as Bioaccess LA, Bausch Health, Sanofi Genzyme, and Sanofi Aventis.
Mr. Harvey holds a Pharmacist degree with a specialization in Management Pharmaceutical Marketing from Universidad El Bosque.
Ms. Sara Ruggieri
Former PV Specialist at the AIFAMs. Sara Ruggieri brings over 22 years of expertise in pharmacovigilance, with extensive knowledge of European regulations, Good Pharmacovigilance Practices (GVP), and key FDA industry guidance. As a former pharmacovigilance specialist at the AIFA Health Authority of Italy, she has a deep understanding of regulatory requirements and compliance.
Ms. Ruggieri has led numerous pharmacovigilance compliance projects, specializing in PSURs, DSURs, ACO, Clinical CTD modules, and PSMF maintenance. She is adept at managing PV agreements, SDEA, quality systems, and SOPs. Her proficiency extends to medical information management, risk management plans (RMP), renewal assessments, safety document creation, and local PV file updates.
She holds a degree in Chemistry and Pharmaceutical Technologies and a Master’s degree in Clinical and Epidemiological Research Coordination.