Menarini Biotech > Capabilities > Quality Assurance

Capabilities

Quality Assurance

Above and beyond

We pride ourselves on attaining the highest standards of quality and regulatory compliance (EMA and FDA) and are licensed by the Italian Ministry of Health (AIFA) for the manufacture of Phase III clinical supply for human use.

Menarini Biotech’s primary objective is to work effectively and efficiently in partnership with our customers to produce safe, efficacious, quality biologics that ensure a smooth path to market.

We meet the highest levels of compliance with European and FDA regulations and guidelines for the manufacture of therapeutic biopharmaceuticals for clinical use. We are continually improving our quality system with regulatory intelligence and routine internal audits.

We provide this assurance as standard, but strive to give you more. We also share our expert knowledge of regulatory processes and offer support for your applications.

Take advantage of our:

Full compliance with European Clinical Trials Directive 2001/20/EC and FDA standards
Authorisation by AIFA (Italian Healthcare Authority) for the cGMP manufacture of Investigational Medicinal Products (IMPs)
QP release
Shipment to clinical trial sites
Provision of regulatory support including assistance in the compilation regulatory submissions
Support with CMC filings including face-to-face agency meetings
Representation at AIFA and FDA meetings to support programmes
Process and facility validation advice services
GxP consultancy
Validation package (IND, IMPD, BLA)

Get in touch to benefit from our expertise and experience today

INFORMATION NOTICE PURSUANT TO THE APPLICABLE DATA PROTECTION LAW
Before contacting us please read and agree to the information notice

This information notice is provided pursuant to Section 13 of the Italian Legislative Decree No. 196/2003, as amended (the “Italian PDPA”) and applies to personal data voluntarily provided by users (“Data Subjects”) who use the services of the company website www.menarini-biotech.com (“Site”).
Data Controller and Data Processor
The Data Controller is Menarini Biotech s.r.l. (“Company”), with registered offices in Via Tito Speri, 12, 00040 Pomezia (Rome), Italy, Phone +39-06911841.
The Data Processor is the Head of Business Development Dept. of the Company.
Purposes and Methods of Data Processing
The Company may process personal data for the sole purpose of processing your requests and/or enquiries (including but not limited to, requests for technical assistance and for scientific and promotional information, and communications also of a commercial nature).
Moreover, with your optional consent, your data may be processed for commercial / promotional / marketing purposes. This includes providing you with promotional material and/or commercial information relating to the Company’s services by traditional methods (for example: hard copy mail, operator calls, etc.) and automated ones (for example: e-mail, fax, text messages, mobile and smartphone apps, social network accounts, (i.e. via Facebook or Twitter), etc.).
Your personal data are processed both in paper and in electronic form. Data are entered into the Company information system in compliance with the Italian PDPA and according to profiles of data security and confidentiality, in line with the principles of fair and legal data processing.
Pursuant to Section 11 of the Italian PDPA, data are retained for the time strictly necessary to achieve the specific purposes for which they were collected.
Type of Data Processed
Where marked by an asterisk [*] personal data are essential for the Company to process your requests and/or enquiries (i.e.: your requests for information and/or materials) or to contact you to follow up your queries. Refusal to provide data marked by an asterisk will prevent the Company from providing the services you may have requested. The provision of any other data is optional: refusal will not have any implication on your request.
Providing your personal data for marketing purposed as specified in the section “Purposes and Methods of Data Processing” is optional: your refusal to provide such data will not have any implication on your request.
Your consent to the processing of your personal data for commercial / promotional / marketing purposes is meant to include communications by traditional and automated methods, as above exemplified.
As per the use of cookies on the Site, please refer to the specific section of the Privacy Policy of the Site.
Access to your Personal Data
Your personal data will be accessible only to the personnel in charge of data processing within the Company. In relation to their duties, such personnel needs to process your data to manage your requests. Data may be disclosed to employees of the other companies of the Menarini Group for the same purposes as stated above and/or for administrative purposes, pursuant to Section 34, Paragraph 1, of the Italian PDPA.
Without prejudice for the provisions of the above paragraph, your personal data are not communicated to third parties, be it natural or legal persons, and they will not be disseminated in any other manner or form.
Rights of the Data Subjects
You may at any times exercise the rights established by Section 7 of the Italian PDPA, including your right to receive confirmation of the existence of your personal data within the Company, your right to check the content, the source and the accuracy of your data, and/or to request that your data are updated, erased and/or de-identified, if unlawfully processed, as well as your right to stop the processing of your data for any legitimate reasons.
Please be informed that, pursuant to the Italian PDPA, your right to stop the processing of your data for marketing purposes performed by automated methods is meant to be extended also to communications by traditional methods. However, you are also entitled to partially exercise your rights (i.e. exercising it towards the processing performed by automated methods only and leaving the traditional ones or vice versa).
At any times you may apply the Data Processor, in the person of the Head of the Business Development Dept. of the Company (at the above address, or by phone at: +39-06911841) to receive information on the processing of your personal data by the Company, to exercise the rights established by the Italian PDPA, as well as to receive the updated list of subjects to whom data are accessible.

Having read the above information notice concerning the processing of my personal data, I give consent to Menarini Biotech to process my personal data for the sole purpose of processing my requests, communications and/or enquiries.