Dear VITROBIO Partners and Clients,

The entire Vitrobio team wishes you all the best for 2024 and would like to take this opportunity to thank you for your trust and unwavering support. Our partnerships and collaborations are the pillars of our success, and we look forward to continuing to play an active part in strengthening your developments and successes in the year to come.

Management

• Evolution of Vitrobio

We are pleased to inform you of an important milestone in the evolution of VITROBIO. Founded in 1994 by Dr Ravi SHRIVASTAVA, our organization’s mission has always been to develop high-quality treatments for often complex pathologies.

Last quarter of 2023 marks a significant turning point for VITROBIO. Following the retirement of Dr Ravi SHRIVASTAVA, Rémi SHRIVASTAVA, is now President of the company. After a PhD in neurobiology and an MBA, he is determined, along with the entire VITROBIO team, to carry on and enrich his father’s legacy with the aim of meeting your expectations even better. Dr Ravi SHRIVASTAVA will continue to work with Vitrobio’s team bringing his vast experience to the organization.

• Materiovigilance

Please note that your Materiovigilance Correspondant is now: Ms Séverine Dameron-Puech – vigilance@vitrobio.com

As part of our proactive approach to collecting information on our products, we have implemented an online survey for patients, which you can distribute through your sales network:

All products feedback

New infrastructures

• Biocorp subcontracting

Vitrobio SAS always strives to respond efficiently and reactively to all your requests. So, as you were informed a few weeks ago, to support the significant increase in our production and to ensure the best possible delivery times for your orders, Vitrobio SAS has signed a  partnership with BIOCORP, to carry out the production of Vitrobio’s products.

We draw the attention of distributors who address markets outside Europe. It is your responsibility to check that the addition of this production site has no impact on the registration of your products with national authorities. If such is the case, please inform Vitrobio by e-mail at Regulatory@vitrobio.com. In this case, the production of your references concerned will not be carried out by BIOCORP. This will remain the situation until you have taken the necessary steps with your national authorities and informed us.

• Storage facility

In view of increasing production volumes, a new building has been constructed on the Vitrobio site to store your finished products in optimum conditions. This building is equipped with a temperature control system. All the building’s installations have been qualified and approved by our notified body. This new storage facility is now fully operational.

• Ordering process

Please be informed of our updated order placement procedures:

• To initiate a new order, we kindly request that you send us your order in PDF format to orders@vitrobio.com or utilize our online ordering form. We can no longer accept production requests via email.
• Please note that our lead times are 4 months, unless otherwise specified in your contract.

For any assistance, feel free to reach out to our dedicated contacts at Vitrobio:

• Nathalie MANEBY (orders@vitrobio.com) for placing new orders.
• Rémi SHRIVASTAVA (client@vitrobio.com) for order tracking or any other inquiries.
• Eva PETOT & Florent MIZOULE (production@vitrobio.com) for validation of packaging, leaflets, and shipping documents.

We appreciate your cooperation and look forward to continuing our successful partnership.

Vitrobio Order form

Regulation (EU) 2017/745 (MDR)

Vitrobio Certification Update

Vitrobio is already committed to the transition to MDR. An application for certification under Annex XI part A of Regulation 2017/745 has been submitted to the GMED, for most of the product from the portfolio. Vitrobio products benefit from the extended transition period. They can therefore be produced under certification in accordance with Directive 93/42/EEC (MDD) until 31/12/2028 and can then be kept on the market until they expire according to the Regulation (EU) 2023/607 (Amendment to Regulation (EU) 2017/745). Please note that HG-VB, indicated for the treatment of genital herpes, and formula VB-PHR-E, indicated for the treatment of sore throat in children, do not benefit from the transition period and will therefore no longer be manufactured after 26 May 2024.

Vitrobio was audited in March 2023 by the GMED (Initial certification audit under the Regulation 2017/745). This on-site audit did not reveal any major non-compliance (0 major non-conformities) and Vitrobio already obtain a favourable opinion for certification of the quality management system. Certification is conditioned by the conclusions of both on-site audit and documentary review. The technical documentation evaluation was postponed by the notified body for reasons beyond the control of Vitrobio.  At this stage, we hope to obtain certification in end-2024.

Please note that one certification does not cancel the other, so the same product can be manufactured under both directive and regulation certification at the same time.

To date, Vitrobio’s certification is well underway to ensure continuity of product availability. 

You can be assured of Vitrobio’s support for all questions concerning your orders, your products or the evolution of your product portfolio.