Life Sciences Consulting

Biotech Intellectual Property Evaluation

With technology advancing at an unprecedented rate, we believe in the power of knowledge-sharing, especially in the life sciences industry. We help clients in biotech intellectual property evaluation in order to accelerate the R&D development process and deliver drugs to patients in a shorter timeframe.

Assessment and Due Diligence

The continued growth of the biopharmaceutical industry is, in part, supported by partnerships, mergers and acquisitions. We facilitate such processes by assisting biotechnology companies with portfolio prioritization and technical and commercial evaluation of in- and out-licensed assets. Our services include preclinical review for pharmacology and toxicology, clinical and commercial assessment, and advice on clinical trial strategy.

Followed by the assessment process is our due diligence process. All available information from the public domain is assessed and used to identify potential opportunities for an asset. This asset then undergoes further evaluation, and a detailed risk analysis is conducted in order to fully assess the opportunity for investment and deal structuring.

Technology Asset Valuation

We are the expert in valuating development cost and assessing market potential. Our team has, in various areas, assessed over 50 assets, including a variety of modalities such as small molecules, biologics, regenerative medicines and medical devices.

With our integrated, cross-functional regulatory and clinical teams focused on medical value communications, patient-centered outcomes and real-world evidence, JRC is able to provide in-depth pricing and market access expertise to define and communicate the value of novel therapies for optimal commercial success.

MRCT Services and China NMPA Submission

We also provide services to assist U.S. sponsors in conducting MRCT (Multi-Regional Clinical Trials) in China. In addition to our well-established relationships with Chinese hospitals and CRO partners, our experienced regulatory team is able to provide customized services and professional advice that allow U.S. sponsors to successfully conduct trials in China. Our team utilizes an online data platform to assess the company and review its products. If deemed necessary, we will conduct site visits to manufacturing plants, R&D facilities, and/or the company’s corporate headquarter. Once our team of experts has analysed all available information and performed a rigorous pharmaceutical due diligence review, we will report our findings and recommendations to the clients, which may include general recommendations, go or no-go advice, regulatory hurdles and suggested next steps.

In addition, we are also dedicated to helping clients optimize clinical success for their product candidates. From drug discovery to phase 3 clinical trials, we provide strategic development plans for product candidates launching in both U.S. and China, shortening the development process and opening the doors for new markets.

In terms of NMPA (National Medical Products Administration, formerly known as the CFDA) submission, the process is complicated and time-consuming. If the submission contains inaccurate or inadequate information, the product’s development may be significantly delayed and its future may be at risk. Our experienced regulatory team invests numerous amounts of time in preparing and scrutinizing each submission, ensuring an impeccable submission for every client, demystifying the regulatory process and saving our clients’ time in the go-to-market process.

Commercialization Solution

The market for healthcare products has become more crowded than ever, and a successful commercialization depends on many factors. To ensure the success of market entry for our clients’ products, JRC develops tailored business plans and solutions that enable clients to strategically launch their products in a new market and gain acceptance.

At JRC, our clinical teams deliver the necessary education about the new products to healthcare professionals, patients and advocacy organizations. Delivering the latest evidence-based scientific information and relevant clinical data about disease states and current treatments can effectively impact the decision-making of consumers in the healthcare industry and enhance acceptance for new products.

Additionally, a Medical Science Liaison (MSL) is often deployed well in advance of a product launch in order to inform the medical community of the new product and gauge acceptance of such product.

Cross-Border Regulatory Consulting

We bridge together the U.S. and Chinese healthcare industries. Our clients in the biopharmaceutical industry include leading biotechnology and pharmaceutical companies, most of which are involved in the most advanced technology in the field. We bring our clients to the U.S. to initiate or continue their research and development activities by collaborating with CROs (Contract Research Organizations) across the states, helping them to ultimately obtain approvals and commercialize their products in the U.S. market.
This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish. Read More
If you would like to get in touch with us, please click here. Contact us