Our different fields of Expertise
- Qualified Person service
- Quality Service
- Project Management in clinical trials
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QP Partner
« Qualified Person » services.
EYLIO offers its customers several services related to its status as a pharmaceutical laboratory:
- Quality audits of sites: Manufacturers of Drug Substance and Drug Product, Packager, Warehouse, Quality Control laboratory.
- Regulatory expertise: EYLIO, with its experience in clinical trials, offers to accompany biotechnology laboratories on the regulatory level.
- Pharmaceutical release and certification.
EYLIO proposes to its customers and in conformity with the Annex 16 of the G.M.P. :
- The assumption of responsibility for raw materials manufactured in a third country via the "Qualified Person Declaration".
- Confirmation of a manufacturing step of a drug.
- Certification and release of a batch of drug for clinical trials or with a marketing authorization.
Our services
Service
QP Batch Certification
details
Release of the finished products which can be used in the EU for marketing authorization for clinical trials.
Service
QP Batch Confirmation
details
Signed statement confirming, for instance, that the bottling of tablets, etc, has been conducted in accordance with EU GMP and PSF or CTD standards.
Service
QP Declaration
details
Declaration safe guarding your Investigational Medicinal Product (active or placebo substance) or Marketed Product have been manufactured in accordance with EU GMP standards.
Service
Importation
details
Request for import authorization from the French authorities
Service
Quality audits and CAPAs follow up
details
Audits of Manufacturers of Drug Substances and Drug Products, Packagers, Warehouses, Quality Control Laboratories related to GMP compliance for Investigational Medicinal Product or Marketed Product
Service
Regulatory expertise
details
Advice on GMP compliance, Development Plan and Strategy Definition.
Service
Product Specification Files
details
Simply a reference file with all information necessary to draft the detailed written instructions on processing, packaging, quality control testing and finally batch release.
Service
External Quality Assurance System
details
QMS plan definition, SOP writing, Change Control, Training documentation, CAPAs management, Follow-up of subcontractors (Quality Contracts, Deviations, Audits, CAPAs management), Follow-up of quality indicators (Trained personnel rate, Closure rate of deviations, Closure rate of CAPAS)
Service
Project Management in clinical trials
details
Support clients in the DS/DP manufacturing steps and packaging steps : Writing of Contracts (QTA, Specifications, …) with the sub-contractors, Operations follow-up, Kits design and needs definition.
Setting up packaging, storage and distribution activities : CMO selection, management and follow-up, GANTT charts establishment, Monitoring shipments from the various sites.
Setting up packaging, storage and distribution activities : CMO selection, management and follow-up, GANTT charts establishment, Monitoring shipments from the various sites.
Service
Storage
Soon available
details
IMP Storage : from -80°C to 25°C in a secure area.
DS/DP Storage (bulks) : from -80°C to 25°C in a secure area.
DS/DP Storage (bulks) : from -80°C to 25°C in a secure area.
Service
Quality Control
Soon available
details
QC Identification
Service
Manufacturing, packaging, distribution
Soon available
details
Fill & Finish: Small Batch Production of active/placebo products.
Packaging: Secondary packaging, clinical labelling and blinding Distribution to Investigational Sites.
Return & Destruction: Return from investigational sites and destruction after sponsor agreement
Packaging: Secondary packaging, clinical labelling and blinding Distribution to Investigational Sites.
Return & Destruction: Return from investigational sites and destruction after sponsor agreement
