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Regulatory Operations and Market Entry Optimisation

We empower organizations to achieve optimal performance and deliver exceptional results

Regulatory Operations and Market Entry Optimisation

We empower organizations to achieve optimal performance and deliver exceptional results

Who we are

Welcome to Romeo Life Sciences, the premier consulting firm for all your pharmaceutical, medical device, food supplement, and cosmetic needs. Our diverse and experienced team boasts scientists, market access experts, and regulatory affairs specialists who excel in areas such as submission preparations, regulatory agency interactions, medical writing, market access, import-export and distribution, and ISO consultancy. With a focus on meeting urgent and long-term global product development needs, we provide top-notch advice and services to ensure the success of your projects.

At Romeo Life Sciences Consulting, our driving force is our passion for innovation and dedication to providing top-quality service to our clients. This dedication to excellence is rooted in our extensive expertise across all aspects of the life science process.

Memberships & Qualifications

Our Expertise

Early Clinical Development

Specialized expertise and customized support to pharmaceutical and biotechnology companies during the initial stages of bringing a new drug or therapy to market. These services aim to streamline the drug development process, improve efficiency, and increase the likelihood of successful outcomes in early clinical trials.

Oncology

In-depth understanding of the regulatory and reimbursement environment for oncology treatments. Strong relationships with regulatory bodies, payers, and key opinion leaders. This allows us to develop a comprehensive approach, encompassing clinical trials, evidence generation, regulation, HTA, reimbursement, and postmarket implementation.

Medical Devices

We offer comprehensive development and commercial services that guide medical device manufacturers through the entire CE Marking process, ensuring their products are successfully brought to market.s.

In Vitro Diagnostic

Tailored assistance in navigating the latest challenges of the In Vitro Diagnostic (IVD) Regulation with our customized support.

Digital Health

Our team of digital experts is equipped to assist Pharma and MedTech clients in their pursuit of innovative digital health technology solutions.

Tenders

Our business partnerships with manufacturers and suppliers allow us to participate in a wide range of tenders. We use our expertise in sourcing and distribution to ensure competitive pricing and reliable supply within the strict timeframes of tenders.

Nutraceuticals

Market entry strategies for new nutraceuticals and product registration in compliance with regulatory requirements.

CBD Products

We provide services that ensure compliance with all CBD regulations and succeed in bringing legal cannabis and CBD products to market.

MDRP Provision

The main responsability of Medical Device Registered Person (MDRP) is to ensure compliance with the industry's applicable Medical Device Regulation and local legislations, as well as, with the regulatory, quality and safety agreements with the Manufactureers or Suppliers.


Our Services

Market Access Consulting

Clinical Regulatory & Quality System

Import/Export & Distribution

ISO Consultancy

Market Access Consulting

Clinical Regulatory & Quality System

Import/Export & Distribution

ISO Consultancy



Get in touch

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