Core Team

Dr. Ramesh Pennamareddy

Dr. 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

Mrs. 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

Dr. 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.

Mr. Shiv Kumar Somani

Mr. 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.

Mr. R V Ravindrnadh

Mr. R V Ravindrnadh is a seasoned pharma professional with a distinguished career spanning over two and a half decades in the domestic formulation sector and two decades in the international market, specializing in API and Finished Dosage Form. A master strategist with unparalleled expertise in forging successful tie-ups and conducting in-depth market research.

Forerunner, for last two decades, in building up “the Indian National Brain Bee, a revolutionary program that inspires young minds to pursue Neuroscience, driving innovation and progress in the fight against neurological and psychiatric disorders.

Mr. Concepción “Coki” Cruz

Mr. 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. Ariel Cruz Figueroa

Mr. Ariel has over 43 years of specialized experience in the USFDA and the pharmaceutical industry. This includes nine years as a Consumer Safety Officer, where he inspected active pharmaceutical ingredients (API) facilities encompassing chemical synthesis and fermentation as well as finished goods facilities producing sterile products, liquids, solid oral dosages, medical gases, and external-use medications for both human and veterinary use.

Mr. Ariel brings over 34 years of extensive experience in the pharmaceutical industry, specializing in CGMP compliance, product specification adherence, and production standards. His expertise includes writing and revising SOPs, conducting process and cleaning validations, leading deviation investigations, and driving process improvements. He has a deep understanding of production processes, including dispensing, granulation, blending, compressing, capsule filling, coating, branding, packaging, and liquids processing.

Mr. Ariel holds a Bachelor of Science in Chemistry from the University of Puerto Rico and is a certified Lean Six Sigma Black Belt through the American Society for Quality (ASQ). He is also an FDA/ORA Certified Drug Program Investigator (Level I) and a member of the FDA/ORA GDUFA Program.

Mr. Akhilesh Khale

Mr. 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

Dr. 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

Mr. 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

Ms. 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.

Mr. Deyaa Saheen

Dr. Deyaa Saheen has nearly 30 years of global experience in pharmaceutical, biopharmaceutical, sterile manufacturing, biologics, and regulatory compliance operations.

Dr. Saheen previously served as a U.S. FDA Drug Investigator and CDER Compliance Officer, leading and supporting FDA pre-approval and surveillance inspections across APIs, sterile products, biologics, OTC, and generic drug manufacturing facilities.

His expertise includes CGMP compliance, inspection readiness, FDA 483 and Warning Letter remediation, data integrity, CAPA systems, and global regulatory strategy. He has successfully directed more than 250 mock inspections and audit programs across global manufacturing sites, CMOs/CDMOs, and contract laboratories.

Dr. Saheen is widely recognized for strengthen quality systems, improve regulatory compliance, and achieve sustainable inspection readiness across complex global operations.

Dr. Erik Østergaard

Dr. Erik Østergaard has more than 25 years of experience in the control and analysis of vaccines and biologicals using bioassays, immunoassays, HPLC, and potency methods.

Dr. Erik worked as a Scientific Officer at the biological control laboratory (OMCL – Official Medicines Control Laboratory) at the Danish Medicines Agency.

His experience at the Danish Medicines Agency includes the transfer and establishment of bioassays to evaluate method reliability and compliance testing of active ingredients in biologicals.

He participated in a European Pharmacopoeia working group for the development of vaccine monographs and worked as a consultant for the accreditation of Belarus Official Medicines Control Laboratories.

Janis Zvejnieks

Mr. Janis Zvejnieks is an experienced pharmaceutical and regulatory affairs professional with extensive expertise in pharmaceuticals, dietary supplements, pharmacovigilance, GDP, GMP, quality systems, and regulatory compliance. He has significant experience supporting pharmaceutical companies in regulatory affairs, pharmacovigilance, and quality management activities.

Mr. Janis previously served in key positions contributing to pharmaceutical development projects, GMP-related operations and Qualified Person, overseeing pharmaceutical operations in compliance with EU GDP requirements, including quality systems, inspections, recalls, and compliance management.

He further held senior leadership roles at Industries and served for more than six years as Deputy Director at the State Agency of Medicines of Latvia, gaining extensive expertise in pharmaceutical regulation, inspections, and healthcare compliance.

Dr. Khatuna Gabisiani

Dr. Khatuna Gabisiani is a pharmaceutical quality and compliance professional with more than 20 years of experience in pharmaceutical manufacturing, distribution, pharmacovigilance, regulatory inspections, and quality systems auditing.

She currently works as an independent Contract GxP Auditor, conducting GDP, GMP, GVP, API, excipient, packaging, and cosmetic GMP audits for pharmaceutical and healthcare organizations. Previously, she served as a GMP Inspector at the Ministry of Labor, Health and Social Affairs of Georgia / LEPL Regulation Agency of the Medical and Pharmaceutical Activity, participating in inspections aligned with EU GMP requirements.

Her experience includes leadership and operational roles within pharmaceutical distribution, quality control, marketing, and international pharmaceutical companies, with expertise in QMS, CAPA, deviation management, data integrity, thermal validation, pharmacovigilance, and regulatory inspection readiness.

Dr. Khatuna holds a PhD in Biochemistry and is an IRCA-trained Lead Auditor (ISO 9001:2015).

Mr. Lawrence Ellul

Mr. Lawrence Ellul is an experienced pharmaceutical quality and compliance professional with more than 25 years of expertise in GMP compliance, validation, quality assurance, auditing, batch release, and regulatory affairs within the pharmaceutical industry.

Mr. Lawrence Ellul currently operates as a freelance Qualified Person and consultant through LJE Consultancy Malta, supporting pharmaceutical manufacturers with GMP and GACP audits, batch certification, quality systems, CAPA management, deviation handling, and regulatory compliance activities.

He has extensive experience auditing API manufacturers, oral dosage form manufacturing facilities, warehouses, packaging sites, and medical cannabis cultivation and manufacturing operations in compliance with international pharmaceutical standards.

Mr. Lawrence previously held senior Qualified Person and quality management positions at Aurobindo Pharma, Actavis Pharma, and Panaxia Pharmaceutical Industries, where he gained significant expertise in GMP inspections, validation programs, stability management, troubleshooting, and pharmaceutical quality systems.