TRUE INNOVATION

COMES FROM RESEARCH

True innovation comes from research. This belief is summarized in our motto: “From bench to bedside”.
For this reason, 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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In order to have the indications of your medical device certified by the notified body, the evidence must be presented with a solid methodology, integrating the data present in the literature on equivalent medical devices with any clinical data collected on your medical device.

The methodology is precisely described both in MEDDEV 2.7 / 1 and in the Medical Devices Regulation (EU) 2017/745. The D&V farma scientific team members either direct or belong to laboratories characterized by a high quality scientific production, a requirement that allows them to master the data analysis methodology necessary for certification.

Biological Evaluation

Drafted in accordance with ISO 10993-1: 2018

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Primum non nocere is the cornerstone on which both the medicine and the legislation on medical devices are based. Starting from the medical device design, the ISO 10993/1 indicates how to collect the safety data present in literature and, if necessary, which laboratory tests to perform and how.

The collection of safety data present in the literature is integrated within the Italian and European regulatory framework that increasingly takes into account animal welfare. Toxicology and pharmacology opinion leaders are key members of D&V farma scientific team.

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Postmarket vigilance and surveillance

Always updated performance and safety of your DM

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Are you aware of all the potential of your DM? Both in 93/42 and in the MDR, post-marketing vigilance and surveillance play a crucial role in the life of the DM. In particular, they monitor and confirm its safety, effectiveness and possibly expand its indications.

Surveillance, as well as clinical evaluation, must be a systematic process and includes various activities carried out by the manufacturer aimed at the proactive collection of data on the DM marketed. Entrust our experts with the preparation of vigilance and surveillance reports.

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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Let your product stand out. Both the surveillance activities (post marketing clinical follow-up) and the promotion of the product require a collection of clinical data.

D&V farma provides support in identifying and interacting with Opinion leaders, in the drafting of protocols and in data analysis.

 

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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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To obtain the maximum yield from the clinical data of your product in terms of professional and scientific audience, we offer a 360 ° assistance: statistical analysis of the data, choice of the target journal, drafting of the scientific article, submission, response to reviewers' comments and proofreading.

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

cups of coffee

WHAT THEY SAY ABOUT US

"In these first years of company growth, we have found in DV Farma a partner of absolute reference.
Precision, scientific competence and problem solving are certainly fixed points in DV Farma's "DNA". 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 had several opportunities for collaboration with DV Farma through my company for the drafting of clinical evaluations relating to bordeline medical devices. DV Farma solo recentemente.
La DV Farma dispone di professionisti altamente competenti nel campo dei Medici Device con competenze scientifiche molto al di  sopra della media.
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

“I have had several opportunities for collaboration with DV Farma through my company for the drafting of clinical evaluations relating to bordeline medical devices.
Punctual, scientifically and technically skilled also in relation to products that have always been considered the most difficult to treat at both regulatory and clinical level.
Also very willing to make small changes and / or updates, in case of special requests from the notified body.
Their clinical assessments are very clear and in compliance with industry regulations!”

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