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.
1. Controlled Drugs
2. Re-labeling (as allowed by local regulations)
3. Product Recalls and Recovery
4. Contact Us for other materials
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
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.