TRUE INNOVATION
COMES FROM RESEARCH

True innovation comes from research. This belief is summarized in our motto: “From bench to bedside”. Per questo motivo la D&V FARMA bases its activities on two pillars: collaboration with Academic Professors and Researchers and collaboration with industry professionals with decades of experience. The synthesis of these two realities allows us to provide innovative and timely solutions to support our customers.

Our goal is to promote the growth and economic development of customers who decide to rely on our technical and scientific skills and expertise in the field of medical devices and dietary supplements.

Our Services

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BD & Licensing

Are you searching for innovative...

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Are you searching for innovative, patented, scientifically sound and ready to market products to create or expand your portfolio?

Check the opportunities that our partners make available.

Visit the dedicated page

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Clinical evaluation

Drafted according to MEDDEV 2.7/1 Medical Devices Regulation (EU) 2017/745

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Al fine di far certificare dall’organismo notificato le indicazioni del vostro dispositivo medico, le evidenze devono essere presentate con una metodologia solida, integrando i dati presenti in letteratura su dispositivi medici equivalenti con gli eventuali dati clinici raccolti sul vostro dispositivo medico. La metodologia è descritta in maniera molto puntuale sia nella MEDDEV 2.7/1 che nel Regolamento Dispositivi Medici (UE) 2017/745. I componenti del team scientifico della D&V farma dirigono o fanno parte di laboratori caratterizzati da una elevata produzione scientifica di qualità, requisito che permette loro di padroneggiare la metodologia di analisi dei dati necessaria per la certificazione.

Biological Evaluation

Drafted in accordance with ISO 10993-1: 2018

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Primum non nocere è il cardine su cui si basa la medicina ed i particolar modo la normativa sui dispositivi medici. Sin dalla progettazione del dispositivo, la ISO 10993/1 indica come raccogliere i dati sulla sicurezza presenti in letteratura e, se necessario, quali test di laboratorio eseguire e come. La raccolta dei dati di sicurezza presenti in letteratura si integra all’interno del quadro normativo italiano ed europeo che tiene sempre più in considerazione il benessere animale. Opinion leaders in tossicologia e farmacologia sono parte integrante e fondamentale del team scientifico della D&V farma.
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Postmarket vigilance and surveillance

Always updated performance and safety of your DM

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Conosci tutte le potenzialità del tuo DM? Sia nella 93/42 che nel MDR la vigilanza e sorveglianza post marketing ricoprono un ruolo cruciale nella vita del DM. In particolare, ne monitorano e confermano la sicurezza, l’efficacia ed eventualmente ne ampliano le indicazioni. La sorveglianza, così come la valutazione clinica, deve essere un processo sistematico e comprende diverse attività svolte dal fabbricante finalizzate alla raccolta proattiva di dati sui DM messi in commercio. Affida ai nostri esperti la redazione dei report di vigilanza e sorveglianza.

Drafting expert reports

to respond to competent authorities’ comments

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Keep calm and answer back. Faced with harmonized legislation at European level, the competent authorities of each state have the right to request additional documentation to support the efficacy, safety or even the correct regulatory classification (i.e., medical device or drug). The drafting of an expert report with solid scientific foundations countersigned by university professors with consolidated experience is essential to guarantee the marketing of the DM.  
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Consulting services for clinical investigations

Support in planning, management and execution

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Lascia che il tuo prodotto emerga. Sia le attività di sorveglianza (post marketing clinical follow-up) che la promozione del prodotto necessitano di una raccolta di dati clinici. La D&V farma fornisce supporto nell’identificazione e nell’interazione con Opinion leader, nella stesura dei protocolli e nell’analisi dei dati.  
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Preclinical Studies

Test your hypothesis

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Test your hypothesis
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Medical Writing

From the raw data to publish paper

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Per ottenere la massima resa dai dati clinici del vostro prodotto in termini di audience professionale e scientifica, offriamo un’assistenza a 360°: analisi statistica dei dati, scelta della rivista, stesura dell’articolo scientifico, sottomissione, risposta ai commenti dei revisori e correzione delle bozze di stampa. I nostri medical writer non sono semplici free-lance ma sono ricercatori universitari che di routine generano dati scientifici e scrivono articoli scientifici.

Party’s expert

Make your opinions heard

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Make your opinions heard. In civil proceedings, technical consultancy is the activity carried out by an expert with specific skills and knowledge. We assist companies and law firms to assert their point of view in cross-examination with the judge’s expert.

Drafting Patents

Create added value

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Create added value. It is essential to protect the strengths of your DMs to make sure they remain unique. D&V farma has 10 years of experience in drafting patents and collaborates with several law firms that deal with industrial property. We can support you in the drafting of the patent, in the collection of data to support the claims, in the response to research reports as well as in the patent enforcing.

Who are our clients?

Our customers are small and medium-sized pharmaceutical companies that are expanding into the medical device and supplement industry. D&V Farma proposes, manages and supports the services necessary for the enhancement and expansion of its customers' market through time optimization and perfect knowledge of all the necessary mechanisms.

WHY CHOSE D&V FARMA

D&V Farma Srls was founded in 2018 with the aim of combining experts in the pharmaceutical field who collaborate organically in the development of medical devices and dietary supplements.

Our Skills

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Reliability

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It is the first recognition that our customers give us. For this reason, in addition to entrusting us with their projects, our customers recognize us as an integral part of their team and interface with us even for simple advice. Test us!
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Fast

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D&V Farma has meticulously built a network of experts and an operating model with the capability to rapidly provide the client with effective solutions.
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Commitment

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We put the maximum effort into every project by offering solutions that are a real added value for our customers, going beyond the mere execution of the assigned task.
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Expertise

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The D&V Farma team is made up of members with decades of experience in their field. Expertise and professionalism is what we ask of our experts and it is what we want to offer our customers.

D&V FARMA IN FIGURES

In the first two years of activity, we have supported more than 20 Companies in the registration, response to ministerial objections and development of about 70 medical devices and dietary supplements.

Clients

Products

funded patents

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WHAT THEY SAY ABOUT US

“In questi primi anni di sviluppo Aziendale, abbiamo trovato in DV Farma un partner di assoluto riferimento. Precisione, competenza scientifica e problem solving sono certamente dei punti fermi nel “DNA” di DV FarmaWe will certainly continue to count on them for many of our future projects.” Paolo Lategano CeO FB vision
Paolo Lategano

CeO , FB vision

I have been dealing with Medical Devices for about 26 years and I only recently had the opportunity to work with DV Farma. DV Farma has highly competent professionals in the field of Medical Devices with scientific skills far above the average. In fact, I was able to use their support for clinical evaluations for some of my clients who manufacture medical devices and, even with the most difficult evaluators, we reached the goal of certification without any difficulty.
Vincenzo Iaselli

Regulatory Affairs, Italdevice srl

“Ho avuto diverse occasioni di collaborazione con la DV Farma tramite la mia azienda per la stesura di valutazioni cliniche relative a dispositivi medici bordeline. Puntualissimi, preparati scientificamente e tecnicamente anche relativamente a prodotti che sono da sempre considerati i più difficili da trattare a livello regolatorio/clinico. Disponibilissimi anche ad effettuare piccole modifiche e/o aggiornamenti, in caso di richieste particolari provenienti dall’ON. Le loro valutazioni cliniche sono chiarissime e in compliance con le normative di settore!”
Fabiola Di Giacomo

Regulatory Affairs, D.M.G. Italia s.r.l.

CONTACTS

D&V Farma

Opening time: we are available 24 hours a day

email: dv@dvfarma.com

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