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

Who Can Avail Our Range Of Services
Unlocking the Potential of Healthcare through Tailored Solutions
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
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.

Roche sets bar in early lymphoma treatment with Polivy study results
(published - biopharmadive) Roche said its cancer drug Polivy combined with a common chemotherapy regimen held lymphoma in check for longer than the standard drugs alone in patients who had not been.

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...