OUR COMPANY


Global Medical Logistics


GML value proposition is to provide quality, regional customized and integral targeted solutions in logistics and regulatory affairs, to boost our client success during research & development phases up to bringing to market products for the cure or manage diseases.

Read More From top pharmaceutical, biopharmaceutical, biotechnology, medical devices companies, logistics industry, CCOs, CROs and medical scientific professionals, we have helped clients developing and implementing efficient processes to meet regulatory requirements within the parameters of defined business goals, conduct their projects, while they focus their resources on more strategic value core competencies such as drug innovation and accelerated time to market.

Is our belief that the selection of a fully qualified strategic ally and the integrated, reliable and timely solutions it offers, are the key to strong relationships. We are proud to have expanded our services and capabilities while keeping and repeating business with our clients.

GML is a regional company, act as a single supplier solution in several countries for our clients’ projects, working under the same quality management system is an advantage for simplicity and efficiency instead of having fragmented processes and multiple players.

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GML your reliable business partner


Distinguished regional-renowned expertise, proven in more than 300+ international projects we have participated up to date in the Region (Guatemala, Costa Rica, El Salvador, Honduras, Nicaragua, Panama, Dominican Republic, among other Countries), this expertise is based and supported on 20+ year experience of our senior management team.

Read More Keenly focused in fully adherence of Best Practices, highest quality standards, local regulations and guidelines, client & project specifications, to ensure on behalf of our clients, compliance with regulatory requirements, laws and regulations required by regulatory agencies.

Our workflow processes and procedures are governed by a full suite of SOPs offering a regional standardized trusted process.

To ensure our capabilities as your vendor, we are willing to participate in your qualification processes, starting with providing company preliminary information, participating in your qualification – audit processes, improving our quality management system, implementing services or processes according to your quality feedback. As well as implementing quality-technical agreements in addition to standard business terms and conditions.
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Core Business Practices

Global Medical Logistics is committed to establish and maintain a corporate program of adherence to ethical and quality standards as well as the best practices applicable to our business that reflects our philosophy as a leading provider of services.

Read More Our ethical and quality standards are aimed to sensitize each of the members of Global Medical Logistics, shareholders, owners, managers and employees, to ensure that the execution of their duties is always performed with honesty, legitimacy and morality, as well as the guarantee that their work will always be responsible, serious, objective and impartial. Quality management system in place is governed by a full suite or Standardized and regionalized Operating Procedures, compliant with Best Practices, highest quality standards such as ICH-GCP, GMP, GSP, GDP, local regulations & guidelines.

· Ethics code and principles
· Self-Inspection & Internal Audits
· Quality System, ISO 9001 certified
· Quality and continued improvement
· Vendor qualification and requalification program, including vendor training when applicable
· Local regulations and guidelines compliance
· Applicable local permits and licenses
· Anti-corruption practices and bribery – FCPA awareness and compliance program
· Fully committed to protect and respect personal data
· Client & project specifications adherence

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Our Work Team & Leadership

Our empowered, motivated, qualified work team is committed to excellence.

Senior management staff with proven solid knowledge of the regulatory framework in the region, and experience in company’s business development and expanding services portfolio implementing processes and procedures to meet client expectations and needs in full compliance with Best Practices, regulations and guidelines. Participation as lecturers in Best Practices courses and trainings. Demonstrated leadership and management.

Read More GML regulatory, logistics and management specialist’s expertise, is based and supported on multiple regulatory affairs and logistics projects participation, using a unique set of skills and focus, working closely with our clients and GML senior management from project set up to project operations conduction, facing daily challenges and risks promoting successful results and in compliance.

Proven effective communication skills to interact with authorities and regulators. Willing and able to lead and work collaboratively with colleagues to successfully achieve goals and expectations. Initial and continuous training for all our team is observed and maintained, as well as re-training program for the continuous improvement of performance according to each position. During projects we adapt constantly and quickly, making continuous learning part of our culture using all the experiences and lessons as opportunities to learn and improve.

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Member Bio image

Marioli Castillo

Executive Director

Guatemalan, bachelor’s in business administration with a specialization in Human Resources, Certified Clinical Research Associate by the ACRP, Certified ISO 9001 Internal Auditor, Member of the Board of Directors of the Clinical Research Association of Guatemala.

• Over 18 years’ experience in Regulatory Affairs and Logistics  

• As General Manager of a Site Management Organization went over approximately 45, multicentric, multinational Phase II, III, IV clinical trials, managing several research centers in the Country, responsible for the training, planning, management, monitoring of development until the end of the study. Business development and expanding portfolio of services to Guatemala, Panama and Dominican Republic. Planning and implementing regulatory and depot services.

• Demonstrated leadership and management, proven experience working closely with Sponsors or CROs from feasibility phase and site identification up to clinical trial conduction, leading regulatory process for the development of clinical trials and their proper development planning.

• Extensive experience in development, implementation and monitoring compliance of Standard Operating Procedures, Good Clinical Practices, Good Storage and Distribution Practices.

• Coordinator and lecturer of 13 Good Clinical Practice courses developed in Guatemala, Panama and Dominican Republic with endorsement and authorization of Ministry of Health authorities between others.

• Solid knowledge of the regulatory framework for clinical trials in Central America and Dominican Republic, logistics, supply chain, pharmacovigilance regulations in Central America and Dominican Republic among others.

• Excellent skills and experience in administrative consulting and quality.

• Effective communication skills to interact with authorities and regulators, clients, team members and managers.

• Client oriented, willing and able to lead and work collaboratively with clients to successfully achieve goals and expectations. Main point of contact in GML for new projects and proposals.

Member Bio image

Adriana León

Clinical Logistics Director

Colombian, General Physician, Bioethics Specialist, Master Degree in Medical Sciences, Master Degree in Clinical Trials.

• Certified ISO9001 Internal Auditor

• Over 20 years’ experience in clinical Research, involved in Site Management, Regulatory affairs for a global CRO.

• Solid knowledge of the regulatory framework for Clinical Trials in Central America, Caribe and South American countries.

• Proven experience working closely with Sponsors, CROs and World Wide recognized logistics services companies, for the supply chain for Clinical Trials.

• GCP Certified - Trained in GCP, GMP, and FDA regulations

• Experience in development, implementation and monitoring compliance of Standard Operating Procedures, Good Clinical Practices, Good Storage and Distribution Practices.

• Effective communication skills to interact with authorities, clients, team members.

• Team-oriented professional eager and willing to lead and work collaboratively with colleagues to successfully achieve goals and expectations.

• Demonstrated leadership and management skills.

• Excellent verbal and written communication skills in English, French and Spanish.

Member Bio image

Hellen Sancho

Quality Control & Assurance Director

Costa Rican, Pharmacist.

• Certified ISO 9001 Internal Auditor and Drug Information Association Member.
• Over 16 years’ experience in Regulatory Affairs and Depot Management.  

• Regulatory experience developed as Manager of a Regulatory Affairs Department for a global CRO, in charge of the supervision, submission and regulatory maintenance of clinical studies. In addition, point of contact as regulatory adviser.

• Extensive experience in the implementation of new depots based on Good Storage Practices, as well as the implementation of efficient quality systems that allow the development of activities in a standardized, controlled and replicable manner.

• Extensive knowledge and implementation of Good Clinical Practices and Good Storage Practices and Good Distribution Practices.

• Participation as speaker in GCP courses for Physicians in Costa Rica.

• Strong knowledge of the regulatory framework for clinical trials in Central America and Dominican Republic, logistics, supply chain, pharmacovigilance regulations in Central America and Dominican Republic among others.

• Excellent analysis skills and propose solutions.

• Excellent capabilities for communication both with internal and external customers, staff and senior management. 

• Highly trained professional to work and lead teams to meet the objectives and the expectations of the clients.

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Physical Infrastructure

GMPs, GSPs, GCPs, industry best standards and local regulations compliant.
Storage
  • Ambient temperature (15 ° C-25 ° C),
  • Cold Chain (2°C - 8°C)
  • Controlled Substances
  • Frozen Products
  • Clinical Devices
  • Clinical supplies
  • Equipment
Security 24hours / 7 days a week
Backup energy supply
Inventory Control system 21 CFR Part 11 Compliant
Temperature and Humidity Monitoring system 21 CFR Part 11
Compliant
Validated storage areas (mapped)
Maintenance Program
Pest Control
Cleaning Programs

Let's Get In Touch!


Ready to start your next project with us? That's great! Give us a call or send us an email and we will get back to you as soon as possible!

+502 2261 7400
+502 2295 9234

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