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ICH-Q7-Q10 Principles
21 CFR 210/211 Aligned Systems
cGMP-Aligned Quality Systems
Quality-Driven Operations
DSCSA-Aligned Distribution
ICH-Q7-Q10 Principles
21 CFR 210/211 Aligned Systems
cGMP-Aligned Quality Systems
Quality-Driven Operations
DSCSA-Aligned Distribution
ICH-Q7-Q10 Principles
21 CFR 210/211 Aligned Systems
cGMP-Aligned Quality Systems
Quality-Driven Operations
DSCSA-Aligned Distribution
About Ovantic Life Sciences
Pharmaceutical Manufacturing, Regulatory Discipline, and Targeted Innovation
Ovantic Life Sciences is a U.S.-based pharmaceutical manufacturing and life sciences organization focused on the development, production, and supply of regulated pharmaceutical products, active pharmaceutical ingredients (APIs), and specialty therapies. Our operations are built on cGMP manufacturing standards, regulatory compliance, and disciplined execution across the product lifecycle.
In parallel with our manufacturing platform, Ovantic advances targeted research and development programs addressing rare and underserved diseases, with a long-term commitment to improving patient access, treatment continuity, and therapeutic outcomes.
Who we are
Ovantic Life Sciences operates as a vertically integrated pharmaceutical organization supporting regulated markets through manufacturing, quality systems, and technical expertise. We serve licensed partners, healthcare institutions, and research collaborators seeking a reliable, compliant, and scalable life sciences partner.
Our work spans pharmaceutical manufacturing, API sourcing and oversight, selective private label programs, and orphan drug development—each governed by structured quality systems and regulatory alignment.
Our Mission
Our mission is to manufacture and advance safe, effective, and accessible pharmaceutical products through disciplined operations, regulatory excellence, and patient-centered innovation.
We are committed to upholding the highest standards of pharmaceutical quality and compliance, supporting long-term access to essential and specialty therapies, advancing targeted treatments for rare and underserved patient populations, and building sustainable manufacturing and development programs that withstand regulatory scrutiny.
Executive Management
Ovantic Life Sciences is led by an experienced team of executives, scientific leaders, and regulatory advisors with deep expertise across pharmaceutical manufacturing, compliance, clinical oversight, and global market access.
Our leadership structure is designed to ensure clear accountability across manufacturing and quality operations, strong regulatory governance and inspection readiness, and disciplined decision-making throughout development and commercialization.
TERRANCE SKY
Chief Executive Officer & President
- Terrance Sky serves as Chief Executive Officer and President of Ovantic Life Sciences, where he oversees corporate strategy, pharmaceutical manufacturing operations, regulatory alignment, and business development. He leads the company with a focus on quality-driven manufacturing, regulatory compliance, and disciplined growth across regulated markets.
- Prior to leading Ovantic Life Sciences, Mr. Sky held leadership and advisory roles supporting pharmaceutical and healthcare organizations in navigating FDA regulatory frameworks, strengthening quality systems, optimizing manufacturing operations, and advancing compliant product commercialization. His experience spans pharmaceutical manufacturing, regulatory affairs, and healthcare consulting.
- Mr. Sky’s leadership is grounded in operational discipline, scientific integrity, and long-term value creation. Under his direction, Ovantic Life Sciences continues to expand its manufacturing capabilities and strategic partnerships, supporting the development and supply of regulated pharmaceutical products with a consistent focus on quality and compliance.
Robert Sharpneck
Chief Operating Officer, Ovantic Life Sciences
- Robert Sharpneck serves as Chief Operating Officer of Ovantic Life Sciences, overseeing the company’s global operations, regulatory strategy, and execution. With extensive experience working with the U.S. Food and Drug Administration (FDA) and advising life science companies, Robert ensures that Ovantic’s research and manufacturing processes meet the highest standards of compliance, efficiency, and scalability.
- He brings a strong background in regulatory consulting, operational management, and quality systems, guiding teams in translating scientific innovation into commercially viable, compliant products. At Ovantic, Robert leads cross-functional alignment between R&D, manufacturing, and quality divisions—driving operational excellence and positioning the company for sustainable growth in the pharmaceutical and life sciences markets.
Katy Pena
Senior Quality Advisor
- As Senior Quality Advisor, Katy Pena provides strategic oversight of Ovantic Life Sciences' Quality Management System (QMS), ensuring compliance with cGMP requirements, FDA regulations, and industry best practices. She advises executive leadership on quality and regulatory matters, supports inspection readiness, internal audits, and continuous improvement initiatives, and oversees supplier qualification, contract manufacturing quality programs, and vendor performance.
- Katy also provides guidance on quality risk management, including deviations, CAPAs, change controls, and investigations, while mentoring quality personnel and promoting a culture of compliance and operational excellence. In her advisory capacity, she supports facility qualification, process validation, quality infrastructure development, and strategic growth initiatives across the organization.
Mohammed Al-Sultan
Vice President, Business Development – GCC Region
- Mohammed Al-Sultan serves as Vice President of Business Development for Ovantic Life Sciences in the Gulf Cooperation Council (GCC) region. He leads the company’s strategic growth and partnership initiatives across Saudi Arabia, the UAE, Kuwait, Qatar, Oman, and Bahrain. With extensive experience in regional healthcare markets, Mohammed drives commercial expansion, regulatory alignment, and institutional collaboration to strengthen Ovantic’s presence and deliver innovative pharmaceutical solutions throughout the GCC.
Kamel Moustafa
Vice President, Business Development – MENA Region
- Kamel Moustafa serves as Vice President of Business Development for Ovantic Life Sciences in the Middle East and North Africa (MENA) region. He is responsible for leading the company’s strategic growth initiatives, market expansion, and institutional partnerships across a diverse network of healthcare systems, government agencies, and pharmaceutical distributors.
- With extensive experience in international business development and the life-sciences sector, Kamel brings deep regional insight and a results-driven approach to advancing Ovantic’s mission of improving access to high-quality pharmaceutical products throughout the MENA region. His leadership focuses on building sustainable partnerships, strengthening regulatory alignment, and driving commercial excellence in emerging markets.
Ralph Navarro
Advisor, Technical & Compliance
- Ralph serves as Advisor of Technical and Compliance for Ovantic Life Sciences, bringing over 25 years of experience in the biotechnology and pharmaceutical industries. He specializes in regulatory compliance, quality systems, and operational remediation, with extensive experience working directly with global health authorities, including the FDA.
- Throughout his career, Ralph has successfully led corrective and preventive action (CAPA) initiatives, site-wide remediation programs, and compliance responses to FDA 483s, Warning Letters, and Consent Decrees. His deep technical knowledge and regulatory insight help ensure that Ovantic maintains the highest standards of quality, safety, and operational excellence across all its facilities and product lines.
William E. Burmeister
Chief Scientific Training Officer
- William E. Burmeister is a pharmaceutical research professional with decades of experience in pharmacology and toxicology. He trained in physiology at Eastern Michigan University and conducted cardiovascular pharmacology research at the University of Michigan Medical School before joining Parke-Davis (Warner-Lambert), where he spent more than two decades in scientific and experimental toxicology roles.
- Following his tenure with Pfizer, he served as Director of Practicum Education at the University of Toledo College of Pharmacy, where he expanded a nationally recognized internship program. Mr. Burmeister has authored multiple peer-reviewed publications and abstracts.
- Mr. Burmeister advises Ovantic Life Sciences on pharmaceutical development and scientific strategy.
Michael Hines
Chief Financial Officer
- Michael Hines serves as Chief Financial Officer for Ovantic Life Sciences, bringing more than 30 years of experience in finance, accounting, and strategic planning. He oversees all financial operations of the company, including budgeting, forecasting, and financial reporting, while guiding long-term fiscal strategy and growth initiatives.
- Throughout his career, Michael has worked with leading Fortune 500 companies across healthcare and industrial sectors, where he developed a strong reputation for financial leadership, operational efficiency, and business insight. At Ovantic, he ensures sound financial governance and sustainable growth to support the company’s mission of advancing innovation in life sciences.
Operations, Quality & Compliance Leadership
Ovantic’s operations and compliance leadership ensure that all manufacturing and development activities align with U.S. and international regulatory expectations, including oversight of quality systems, supplier qualification, documentation control, and audit readiness.
Medical & Scientific Leadership
Ovantic’s medical and scientific leadership provides clinical governance and scientific oversight across development programs, including orphan and specialty drug initiatives. This function supports clinical strategy alignment, trial oversight, and scientific integrity across development stages.
Regulatory & Quality Commitment
Quality and compliance are embedded throughout Ovantic’s operations. Our compliance framework incorporates cGMP manufacturing principles (21 CFR Parts 210 & 211), FDA registration, DSCSA and GDP considerations where applicable, and lifecycle quality management consistent with ICH Q10.
Commitment to Rare Disease Innovation
Ovantic Life Sciences is committed to advancing therapeutic programs for rare and underserved disease populations through disciplined program selection, strategic partnerships, manufacturing feasibility, and regulatory planning.
Our Approach
At Ovantic Life Sciences, we prioritize manufacturing excellence before market expansion, compliance before scale, and leadership accountability before branding. This philosophy guides every aspect of our organization.
Contact & Inquiries
Ovantic Life Sciences engages with qualified partners, healthcare institutions, and research collaborators aligned with our regulatory, scientific, and operational standards. For partnership inquiries or additional information, please contact our team.
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5 Concourse Parkway, Suite 3000 Sandy Springs, GA 30328
Saudi Arabia Office
Servcorp Khobar Gate Tower
Al Khobar, Saudi Arabia
Ovantic Life Sciences Inc.
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