our services

Contract manufacturing and filling

Enable Innovations is a flexible and reliable partner in the development and production of sterile liquid products and packaging in single-use vials and multi-dose bottles for medical devices, food supplements, foods for special medical purposes and products for veterinary use.

our services

Regulatory services

Thanks to decades of experience gained in the field of substance-based Medical Devices, we offer assistance in regulatory affairs, from drafting the Technical File to obtaining CE certification for the European market according to the new MDR 2017/745. We also offer support in the Medical Device registration procedure for distribution in non-EU countries.

Chemical-physical and microbiological analysis of raw materials, semi-finished and finished products

Development and optimization of chemical-physical and microbiological analytical methods of raw materials, semi-finished and finished products

Analytical methods validation

Aseptic production processes validation

Performance of microbiological analysis in aseptic environment

Planning and performance of sterilization process validation activities through primary packages irradiation

Design and performance of stability tests in compliance with ICH regulations, for various temperature and humidity conditions

Design and performance of in-use stability tests

Design and performance of on-going stability tests in compliance with GMP

Customers support for drafting and updating of protocols, procedures, QTA, change, etc.

Contacts management, on behalf of customer, with external laboratories for the execution of targeted analysis.

contacts

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Enable Innovations

Location

Via Claudio Tolomeo 20/4
41012 Carpi (MO) – Italy

Contacts

info@enableinnovations.it

Tel: +39 059 6550010

Office Hours

Mo – Fr     08:30 – 17:30

Sa – Su      Closed

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The contents of this website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice because of something you have read on this website. This website does not recommend or endorse any specific tests, physicians, medical products, procedures, opinions, or other information that may be mentioned on the Site. The site and its contents are provided on an “as is” basis by the public communication department of Enable Innovations S.r.l.

Information, images, descriptions and any data reported on the site concerning medical devices are not intended for promotion but as scientific material addressed exclusively to healthcare professionals.

Therefore if keep surfing, the reader declares to be a Healthcare Professional.

References: New guidelines on health advertising of medical devices, in vitro diagnostic medical devices and medical-surgical aids – 20 December 2017

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