Overview
Asia Actual is a leading medical device regulatory consulting firm, specializing in comprehensive regulatory services across several Asian markets. Headquartered in the United States, with operational bases in multiple Asian countries, Asia Actual facilitates medical device registration, independent license holding, and provides importing and commercial support to manufacturers aiming to navigate Asia's complex regulatory landscapes. The firm has managed over 1,010 device registrations, reinforcing its position as a pivotal player in the medical device industry.
Leadership and Key Personnel
Bryan Gilburg
Position: Managing Director, Asia Actual, LLC (USA)
Bryan Gilburg, the founder of Asia Actual, possesses over 20 years of industry experience, notably as the Vice President of Business Development at Emergo Group. His educational background includes an MBA from Kellogg School of Management, Hong Kong University of Science and Technology, and a BA in Economics and East Asian Studies from St. Lawrence University. Fluent in Japanese, Bryan excels in devising strategic expansion plans for markets across Asia.
Gunjan Verma
Position: Managing Partner, Asia Actual Pvt. Ltd. (India)
Gunjan Verma's vast experience lies in Regulatory Affairs and Quality Assurance, highlighted by her role as Director of Regulatory Affairs and Quality Assurance at Zimmer Biomet India. She holds a graduate degree from the Delhi Institute of Pharmaceutical Sciences and Research and a Masters Diploma in Business Administration from Symbiosis Institute of Distance Learning. Her involvement with industry advocacy and reports like the BCG-CII Medical Technology Vision 2025 speaks to her expertise.
Ilham Hidayattulah
Position: Principal Consultant, PT Asia Actual Indonesia
Ilham Hidayattulah brings over ten years of experience in device registrations and quality systems in Indonesia, aiding multinational companies. His expertise covers a range of medical devices, contributing significantly to registration strategies.
David Vo
Position: General Manager, Asia Actual (Vietnam)
David Vo specializes in in vitro diagnostics, with substantial experience in compliance and market research in the Vietnamese market. He holds dual Bachelors in Biotechnology and Law, equipping him with essential skills for navigating legal and regulatory landscapes.
Jack Liang
Position: Managing Partner, Asia Actual (Australia)
Jack Liang has a broad background in regulatory affairs and quality assurance, focusing on the Australian market. His educational credentials in biomedical engineering alongside an MBA in strategic management contribute to his holistic approach to regulatory compliance and business strategy.
Services and Market Strategy
Asia Actual offers a wide range of services aimed at navigating Asia's intricate regulatory environments, primarily in the sectors of medical devices, in-vitro diagnostics, pharmaceuticals, and cosmetics. The company's offerings include registration, reimbursement, and post-market vigilance, along with advocacy and policy development, ensuring adherence to local and international regulations. They leverage strategic regional offices to develop tailored strategies addressing distinct market needs, directly influencing clients' commercial success. Their specialization in novel and high-risk devices positions them as industry leaders, effectively bridging the gap between regulatory challenges and market entry.
Contact Information
- US Headquarters: 515 Congress Avenue, Suite 2100, Austin, TX 78701, +1 512 898-9222
- Asia Headquarters: 116 Changi Road, #04-05, Singapore 419718, +65 8800-3197
Asia Actual's robust presence in rapidly changing Asian markets offers medical device manufacturers crucial support in enhancing their regional footprint and market performance.
Competitor Profiling
1. Midwest Sterilization Corporation
Midwest Sterilization Corporation excels in EO contract sterilization for medical devices, offering customized sterilization cycles or using pre-validated cycles. Located centrally in the U.S., they operate large facilities catering to the medical device sector, with membership in the Ethylene Oxide Sterilization Association underlining their commitment to industry standards and quality.
2. ICCON Global Consultancy
ICCON Global Consultancy provides comprehensive consulting services in validation, qualification, engineering, and training, focused on ensuring regulatory compliance for medical device companies. Their global reach and focus on data integrity and compliance make them formidable competitors in regulatory consulting.
3. Elevation Diagnostics
As a NELAP-certified laboratory, Elevation Diagnostics specializes in environmental and molecular biology testing services. They offer biotech and medical device companies reliable and precise laboratory testing solutions, operating a high-complexity lab equipped with advanced technology.
4. Methodize Inc.
Specializing in regulatory affairs for medical devices and in-vitro diagnostics, Methodize Inc., based in Minneapolis, MN, provides strategic consulting on regulatory submissions, clinical trials, and quality system regulations. With over 175 years of combined experience, their emphasis on swift market entry offers a significant competitive edge.
Understanding the strengths and offerings of these competitors provides insight into Asia Actual's unique market position and informs potential strategies for solidifying its market presence.
