Welcome to Valnizen - Your Trusted Source for 20+ Years of Expertise

IVDR

In Vitro Diagnostic

We are an emerging Medtech-CRO work closely with IVD manufacturers to help them bring their products to market by conducting clinical studies and providing support for regulatory approval. We also offer services related to quality assurance, product testing, and post-market surveillance.

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MDR

Medical Devices

As one of the leading Medtech-CRO we keep in consideration of our clients (Medical Device manufacturers) need and help them to meet the requirements of MDR

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SAMD

AI & Digital Health

SaMD stands for Software as a Medical Device, which refers to software that is intended to be used for medical purposes without being part of a physical medical device. An example of SaMD is a mobile app that analyzes data from a medical device to help clinicians make diagnostic or treatment decisions

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At Valnizen

We Invent For Life

We are committed to improve global health by utilizing the latest scientific research to tackle the world's greatest health threats.

Clinical Research & Trial Management

Looking in to the complex and competitive global medical device landscape, Regulatory approval of medical devices requires convincing clinical evidence. Valnizen ensures adherence to Good Clinical Practices (GCP), the European Clinical Trial Regulation (No 536/2014), the MDR/IVDR, and ISO 14155:2020 – Clinical Investigation of Medical Devices for Human Subjects, as well as ISO 20916:2019 – In-vitro Diagnostic Medical Devices. – Clinical performance studies using human subject specimens – Good research practice MDT can be involved in all or part of your clinical investigation operations, depending on your budget and the availability of in-house specialists.

Regulatory Affairs

Regulatory affairs for medical devices are a complex and highly regulated field that requires careful attention to detail and a thorough understanding of regulatory requirements. In addition to regulatory requirements, medical device manufacturers must also comply with quality management standards such as ISO 13485. These standards provide a framework for ensuring that medical devices are manufactured in a safe and effective manner. To make your compliance efforts impactful in this stringent and sophisticated medical device industry ecosystem, choosing a right regulatory partner is always essential. We are expert in the field providing regulatory consultation and services whether your objective is to develop the rationale for the equivalence of your medical device, confirm your regulatory pathway and your clinical evaluation strategy, or prepare for and obtain market approvals.

Prototyping & Contract Manufacturing

We handhold you in the most crucial steps of your journey of product development i.e, Prototyping and contract manufacturing of medical devices. We enhance the design and development of superior products through the integration of human factors and testing in our processes, from discovery to commercial readiness with the help of our experts’ careful planning and execution to ensure that the devices meet regulatory requirements and quality standards, and that they are manufactured efficiently and cost-effectively.

Commercial Strategies & Market Access

Commercial strategies and market access are critical components of the successful commercialization of medical devices. We perform market evaluations and develop business plans to effectively demonstrate the commercial potential of any product or service bringing them to market and ensuring that they are accessible to patients and healthcare providers.

Disruptive Healthcare Technology Acquisison

Epitome of our company lies in its strategy of acquiring latest disruptive technologies which have potential to disrupt the healthcare industries and solve the critical issues of healthcare sector. We have included Nine disruption from different therapeutic areas such as Oncology, Pulmonary, Gynacology, Beauty, wellness and dermatology, vaccines, digital health platforms, artificial intelligence (AI) and machine learning (ML) algorithms etc to our portfolio and looking for many more. We assure the innovators for taking their technology from innovation to deployment zone.

Our Stakeholders

Who Can Avail Our Range Of Services

Unlocking the Potential of Healthcare through Tailored Solutions

Med-tech Start ups

We are popular among medTech & healthcare startups for our wide range of services in the development of their products, from clinical trial and management to global regulatory affairs support, post-market surveillance.

Innovators

We mitigate the Challenges of Innovators and partnered with innovators at very early stage to provide appropriate Product designing and Prototyping, Clinical evaluation, trial, complying the regulatory bodies and taking care of Regulatory hurdles, Contract manufacturing, market access and commercialization of the product.

International CROs

We seek and welcome International CROs for the products and services targeting Indian market through a collaborative approach.

Device Manufacturers

We provide and support end-to-end regulatory services to all range of device manufactures which can scale up their business.

TBIs

We partnered with MedTech Incubators and TBIs as one stop solution to medTech and healthcare startups seeking Clinical research, Clinical trial and regulatory support to their innovation.

Valnizen can help you in overcoming the Challenges by

  • Initiating Consultation with the Client at an Early Stage
  • Regulatory consulting and communication with FDA and Other Regulatory Bodies
  • Planning and Conducting Clinical Studies
  • Regulatory submission, Approval and registration
  • Market Access

5000+

Patients Screened

60+

Sites Engaged

85+

Studies

6+

Countries

Our Partnersto

Partner with Valnizen

Valnizen is commited to make positive impact on global health by providing end-to-end services to Met-Tech Industries. We invite you to join us in our mission.

From the blog

The latest industry news, interviews, technologies, and resources.

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Practical approaches to operationalizing decentralized clinical trials

(Published – biopharmadive) Prior to the COVID-19 pandemic, there was a trend toward decentralized clinical trials (DCTs). DCTs are trials in which some or all of the participant visits occur outside the...