Contract Manufacturing Outsourcers for injectables

JF MELIN CONSULTANT has selected different Outsourcing partners for development stages (pilot, stability batches) and industrial manufacturing operations with an offer of “Full service for injectables".

Our Contract Manufacturing Outsourcers for injectables are specialized and approved for filling of I.V. solutions in terminal sterilization for :

• PP bags  (from 25mL to 1 000mL)      
• Glass bottles  (from 50mL to 1 000mL)
• Glass vials  (from 5mL to 50mL)    
• Ampoules   (from 1mL to 25mL)             
• Pre-filled syringes (from 1mL to 60mL)

For each of them, we can choose from a large range of standard containers or customized containers based on the specific requirements of your I.V. drug.

Our requirements for our partners :

    Quality,                                                                                                        Confidentiality
                Specialization,                                                   Competitiveness,
                                          Knowledge,              Flexibility,
                                                             Capacity,

Available capacities of our partners for injectables outsourcing

Our approach for each new project :

JF MELIN CONSULTANT assists you from the early stages of development through to the commercial batches manufacturing.
With each of our filling partners, we have built a large portfolio of services :

• A project team dedicated to your project
• Feasibility study
• Formulation development
• Validation of analytical methods
• Stability studies (ICH compliance) depending on type of containers, drug characteristics and regulatory requirements
• Regulatory support for preparation and submission

Aseptic filling for Oncology drugs and Biotech products :

JF MELIN CONSULTANT has chosen also a well-known partner for Aseptic filling for anti-cancer injectables and products of biotechnology in vials, ampoules and, from now in PP bags and pre-filled syringes.
The aseptic filling process is based under isolator technology.
Our FDA approved partner will adapt to your needs for small scale batches (pilot or clinical) to commercial scale.

Outsourcing for Giving sets and devices :

JF MELIN CONSULTANT has referenced two companies internationally known as manufacturers and suppliers of disposable medical administration systems and devices.

With more than 50 years of experience in research and development, our partners are providers of Quality I.V. delivery systems for sets and needle-free devices.
The referenced production sites have EC Certification and ISO Certification for the US & Canada.
All the I.V. giving sets and extension lines are completely free of DEHP plasticizer that gives priority to the patient and minimizes health risks.

Customized I.V. sets specifically developed for safe preparation and administration of cytostatics drugs.
High capacities and flexible manufacturing with an excellent on-time delivery record.