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ARaymondlife

Pharmaceutical establishment

ARaymondlife is a French pharmaceutical company with recognized expertise in plastic processing. Its know-how in thermoplastic injection and bi-injection molding allows it to design and produce parts suitable for both the human and veterinary health industries. Specialized in the manufacture of primary and secondary packaging, ARaymondlife is a real partner for innovation. The company offers its own RayDyLyo® pharmaceutical packaging range and is developing its CDMO activity for pharmaceutical laboratories, medical and cosmetic companies.

 

 

Manufacturing in clean rooms

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ARaymondlife has modern infrastructure based on lean manufacturing principles. The layout has been designed to meet European and American standards for pharmaceutical establishments. The company is organized in several 300m² workspaces dedicated to each type of product. Injection, assembly and primary packaging are carried out in the clean rooms. The controlled atmosphere areas, classified ISO 5, are monitored continuously.

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plastic-injection-raydylyo

Expertise in plastic injection molding

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ARaymondlife has a comprehensive expertise in the injection of medical grade raw materials and unique know-how in the injection of compounds with an integrated active ingredient.

See our page about the impregnated matrix

The company has a new fleet of injection molding machines, both single and and bi-material, from 140 to 220 tons housed in a controlled atmosphere. Fully automated assembly and packaging machines as well as ultra-sound welding machines complete the equipment.
 

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Expertise in plastic injection

An enabling environment

ARaymondlife is located in Grenoble, at the heart of the Rhone-Alps region, close to research and pharmaceutical companies. The plant is located in a region that is home to global leaders in vaccine production, biotech firms, and major players in the human health, animal health and diagnostic sectors. The company enjoys an ecosystem dedicated to research and innovation in close proximity to key players in fundamental research and technology clusters. 

ARaymondlife benefits from this environment of high technology and cutting-edge equipment. ARaymondlife is an active member of MEDIC@LPS, a cluster of biotechnology and medical technology companies.
 

Carte région

Vision

ARaymondlife puts its capacity for innovation, its technical expertise and its quality standards at the service of its customers for the health of patients. The company uses its know-how in plastic processing for the development of solutions for pharmaceutical laboratories, the medical and cosmetics industries. The company's ambition is to be an internationally recognized player.

Certifications

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The company is certified in accordance with NF EN ISO 13485: 2016 for the manufacture of medical devices. In February 2019, the GMED recommended that this certification be maintained.

A multi-skilled department ensures compliance with all the quality management processes inherent in the operation of a pharmaceutical establishment; under the supervision of 2 doctors of pharmacy.

Download the PDF file

Certification ISO 13485

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GMED

Regulatory Affairs

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Since 2008, ARaymondlife has had a French pharmaceutical establishment classification authorised by the ANSES (Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail) and is certified according to Good Manufacturing Practices (GMP) for the manufacture of veterinary drugs

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EU GMP

 

Pharmaceutical Regulatory Affairs

The company sets up Packaging-type Drug Master Files (DMFs) in eCTD (electronic Common Technical Document) format internationally to facilitate the registration of its customers' Marketing Authorization (MA) files. 
Today ARaymondlife has 3 active DMFs - in the US, Canada and China.
 

Medical Regulatory Affairs

The company supports its customers in obtaining CE marking in Europe and 510k clearance in the US for medical devices in classes I, II and III. 

ARaymondlife is also registered as a manufacturer of medical devices in the USA and Japan.

Current certifications

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Pharmaceutical establishment

  • Manufacturing in clean rooms
  • Expertise in plastic injection molding
  • An enabling environment
  • Vision
  • Certifications
  • Regulatory Affairs
  • Current certifications

We would like to hear from you!

Contact us

Presence in the world

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