SERVICES APPROACH


GML is aware that the industry that develops life- changing health products, such as pharmaceutical, research, logistics, devices, commercialization companies, face a set of challenges from product development to achieving commercialization, including an important shift from in-house regulatory affairs and logistics positions to a network of suppliers. In response to this growth and complexity GML is evolving into a dynamic business model, to provide a comprehensive range of clinical services spanning the entire pharmaceutical value chain, using as an advantage our know-how, skills and resources.

Warehousing (Depot), Logistics & Distribution

Accurate clinical supply chain management is a challenging goal, from increased manufacturing costs to more sophisticated and specialized products which require adequate controls and management, where the capability of provide regulations and guidelines compliance through the supply chain is critical.


GML has broad experience in Warehousing, Logistics & Distribution services, in full adherence to best practices and standards, such as GMP’s, GSP’s, GDP’s, GCP’s and local regulations among others, which has enabled us to improve our services, quality and timelines.

We carry out services for all type of health products (pharmaceutical, biopharmaceutical, biotechnology, medical devices, clinical supplies) for clinical research or commercialization.

Local Depots dully certified and authorized by local authorities.

SERVICES

For all type of health products - pharmaceutical, biopharmaceutical, biotechnology, medical devices, clinical supplies – orphan drugs – for clinical research, commercialization, patient support programs

Imports


1. Obtain Import permit | Import License in Country
2. Acting as Importer of Record
3. Customs Release – Brokerage

Local Depot - Storage


In full adherence to best practices and standards, such as GMPs, GDPs, GSPs, GCPs and local regulations, proper storage conditions, accurate accounting and supply chain supporting documents and registers. Regulatory authority authorized depots.
Read More 1. Controlled Drugs
2. Re-labeling (as allowed by local regulations)
3. Product Recalls and Recovery
4. Contact Us for other materials
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Distribution


Accurate and on time distribution, validated shippers to guarantee cold chain, controlled ambient temperature. Transport and on time delivery is handled by our qualified – trained couriers.

Returns of medications and supplies for final conciliation

Returned – rejected product storage will continue to preserve the standards of GMP, keeping accurate accounting and proper storage conditions as needed.

Destruction

Process managed by GML, destruction process performed at destruction company, accredited by the local regulatory authorities, duly qualified by GML. Records and destruction certificates are issued for accurate documentation of the process.

Rare Diseases & Orphan Drug Logistics:

GML qualified logistics experts can provide advice and support to develop and implement unique strategies on a case by case basis to optimize your Rare Diseases & Orphan Drug distribution program, ensuring on time delivery and availability.

Managed Access Programs

GML provides logistics expertise for the supply chain for Managed Access Programs, such as Compassionate Use, Expanded Access Programs, helping and streamline the process to provide access to healthcare products for patients in need.

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 24 hours / 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

Regulatory Affairs

From research & development phases up to bringing to market products for the cure or manage diseases, regulated healthcare industries, such as pharmaceutical, biopharmaceutical, biotechnology, medical devices companies, logistics industry, CCOs, CROs, must abide to a set of regulations and guidelines where a key to success is to establish and adhere to efficient and compliant regulatory strategies.

Read More In this highly regulated environment, local knowledge of a business partner plays a critical role as the interface with regulatory authorities, as a link to the company to provide regulatory strategic advice throughout all stages of drug development and after drug approval and marketing.

At GML our qualified experts in regulatory affairs have proven experience providing consulting advice and regulatory affairs services to regulated healthcare industries to ensure complete adhesion to the applicable regulations and guidelines. Establishing together with our clients, efficient and compliant regulatory strategies.

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Regulatory Affairs Services

Regulatory intelligence during all stages of drug development, marketing authorization and post approval life- cycle management (Clinical Trials, Late Phase, Marketing Authorization, Real World).

Site Identification and feasibility conduct or support: • Immediate access and a data base of pre-qualified investigators in different therapeutic areas, eager and willing to participate in research projects. GML can support during the conduct of Site Identification and feasibility process.

Regulatory submissions and regulatory process follow up during research & development phases:

• Review and adaptation of Informed Consent Form: Aware of the importance of this document, our qualified regulatory experts conduct quality revisions against protocol, good clinical practices guidelines as well as local requirements in each Country.

• Compilation, revision and preparation of submission dossiers including Site documents: Wide experience in regulatory submissions allows GML to review and prepare submission dossiers for local submissions, according to regulatory processes and local requirements, improving timelines and minimizing authorities queries on project.

• Submission to Ethics Committees and Regulatory Authorities: Submissions to regulatory authorities. Acting as local representative for the projects (Clinical Trials, Real World and Late Phase) before regulatory authorities, as a liaison between sponsor – sites – regulatory authorities from initial submission up to approval.

• Regulatory Authorities Queries – Questions analysis and response: Based on regulatory standards, regulations and local knowledge, in case of regulatory authorities queries to project, GML analyze and set forth proposals of response to ease and expedite regulatory approvals.

• Regulatory process maintenance: Acting as local representative for the projects before regulatory authorities, as a liaison between sponsor – sites – regulatory authorities through project conduction to ensure compliance with local requirements, such as amendments, updated documents and project information submissions, project progress and annual reports, continued approvals.

• Safety Information Notification (SUSARs, CIOMS, DSURs, Etc.): Centralized, accurate and expedited process for safety information continued notification to regulatory authorities.

• Design and review of labels: ensuring adherence to local and regional requirements.

• Marketing applications submissions: GML can provide expert and regulations compliant guidance to optimize marketing application processes and streamline your marketing programs.

• Review of technical dossiers according to local regulations

• Submissions and approval follow up

Post approval Life Cycle Management:

• Marketing Authorization Maintenance

• Act as local representative for Company before Ministries of Health and applicable Regulatory Authorities

• Continued monitoring of pharmacovigilance regulations

• Safety Information submissions

• Rare Diseases & Orphan Drug regulatory submissions: GML qualified regulatory experts can provide advice and support to develop and implement unique strategies on a case by case basis to optimize your Rare Diseases & Orphan Drug program.

• Managed Access Programs: GML provides regulatory expertise for the development and conduction of managed access programs, such as Compassionate Use, Expanded Access Programs, helping and streamline the process to provide access to healthcare products for patients in need.

Targeted Solutions

Actual increasing and complexity regulatory affairs and logistics activities of regulated healthcare industries, requires having in place proven standardized methods and procedures, local know-how among others to address efficiently all related activities in compliance with all the applicable regulatory requirements. Companies often needs to back up and rely on a partner to obtain advise & services for project needs.

GML can analyze and consider these needs and after internal analysis of capability GML can propose an “Targeted Solution” according to client or project specifications and needs. GML has developed and provided specific solutions for some clients in the following

Consultancy Services:

GML qualified experts at your service ready to listen to your needs, identifying and supporting you in implementation of solutions and improvement measures that allows fulfilling with the very highest and recognized standards, ethical and regulatory requirements resulting in a high level of credibility and competitiveness of our client´s.
GML has provided Consultancy Services for the Development and implementation of Standard Operating Procedures (SOPs). Aware of the quality that should be offered in terms of activities to be compliant with regulations, standards and best practices, GML provides Consultancy Services through a group of experts in creation, writing, implementation and training of standardized operating procedures.

Pharmacovigilance related services:

Act as local representative for Company before Ministries of Health and applicable Regulatory Authorities
• Continued monitoring of pharmacovigilance regulations
• Safety Information submissions

Training

GML according to client needs can develop and provide training:
• GCP
• Ethics | Bioethics
• Clinical research methodology
• Other, according to scope and expertise

Research Sites Support:

Current and growing complexity of clinical trials requires to have methods and standardized processes to conduct efficiently the different activities and responsibilities which this activity demands.
Sponsors and CROs can centralize main and regular activities for different clinical research sites participating in one same or different trials, in Global Medical Logistics to ensure centralized and integral study management. Likewise, investigators and research sites can be supported on the experience and standardized procedures of Global Medical Logistics to comply with project activities and regulatory requirements.

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