Our IPM Service utilizes all the functions and knowledge that we have acquired through experience to provide solutions to our clients’ various concerns.
Our service cases are as follows:
Situation 1: A company operating in Japan seeks to transfer marketing authorization of a prescription drug.
Pharmaceutical companies often face the challenge of prioritization to improve the focus of their organization. Due to strategic considerations, it happens that pharmaceutical companies wish to divest products by transferring their right to other pharmaceutical companies. How could CMIC Group prove a solution?
OrphanPacific, Inc., a subsidiary of the CMIC Group, was established as a joint venture between CMIC and Medipal Holdings Corp., which has over 300 sites across Japan for the distribution of pharmaceuticals and medical devices. OrphanPacific manufactures and markets orphan drugs for rare diseases affecting small patient populations. The company has experience in various aspects of authorization transfer for orphan drugs and essential drugs, such as regulatory, supply chain, quality assurance, and product strategies. It has also completed authorization transfer free of any confusion or problems in the clinical setting. Clients can remain as marketing and manufacturing authorization holders, and only transfer marketing activities to CMIC. We offer optimal solutions tailored to clients’ individual circumstances. Please visit our website for details.
Situation 2: A company seeks to form an alliance in Japan.
When a pharmaceutical company is primarily focusing on medical affairs and development but would like to outsource post-marketing surveillance and promotion, why is CMIC group a good choice?
CMIC Group has been involved in the efficient management of EPPV (early phase pharmaco-vigilance) and PMS (post-marketing surveillance). Developing strong links with specialists by the provision of tailored medical and scientific information to support the optimal usage of our products, we have gained a good reputation.
Situation 3: A foreign company plans to find a partner in Japan.
As an established R&D organization overseas, a foreign company contemplates launching an orphan drug in Japan but have no affiliate of legal presence in Japan to proceed through the regulatory process of submission, approval, pricing negotiation and terms of supply in the fields via wholesalers. How and why CMIC Group could be the right solution for the company?
CMIC Group has built a robust regulatory affairs management system to provide continuous and specific advisory support to foreign companies willing to introduce new products to the Japanese market. If the situation requires, we offer the possibility to hold the license on behalf of the originating company while operating on its behalf in terms of promotion and medical development. We have an experienced team in drug safety data management that is used to cooperate with firms in Europe and in the US to guarantee the timely and accurate reporting of adverse drug reactions.
Situation 4: A bio-venture or academic research organization plans to develop a new drug.
A bio-venture or academic research organization is primarily focusing on basic research but would like to pursue the feasibility of the new drug through formulation design, translational research and clinical development. How CMIC Group can assist them in this case?
CMIC group has development and regulatory experts so it can guarantee the planning and the coordination of operations. Also, our individual teams are specialized in various areas, including pharmaceutical formulation design, clinical development planning, implementation of studies, manufacturing and marketing authorization applications, and consulting on drug pricing strategies. We will provide high-quality wide-ranging services from optimization of development plans to implementation of studies and application for approval. It is possible to deliver the products across the whole market in compliance with Japanese Good Supplying Practice (JGSP).
Situation5: A new pharmaceutical company is planned to be established.
You have a plan to create a pharmaceutical company in Japan, how could CMIC Group be of help in this project?
CMIC Group can provide support to your plan of creation of a licensed pharmaceutical business while effectively running the commercial, regulatory, and medical business, with a framework of progressive disengagement as your new business gets more resources and staffing. Our group experts’ team will be able to extend support and training to newly formed organization to ensure a smooth transfer of competency.