Consulting
Features of Consultation offered by our company
We have a number of senior-level consultants with decades of experience in research and development at major pharmaceutical companies, and we provide consultation services underpinned by accumulated experiences.
In addition to consultation on clinical trial design, protocol framework planning, and policies for preparation of summary reports and application documents, our experienced consultants propose effective strategies for major development milestones such as PMDA consultation and submission for approval. We will strongly support our clients to achieve efficient clinical development and early approval.
Please feel free to contact us with any questions you may have. We will appoint a consultant with expertise and know-how in the subject matter of your consultation, based on a thorough understanding of your requirements and product characteristics.
Consultation on CTD preparation policy
(approval submission strategy)
Our consultants with extensive experience in regulatory affairs are in charge of consulting on CTD preparation policies. By analyzing in detail the vast amount of clinical trial data obtained, we will identify the characteristics of the product in terms of both safety and efficacy, extract the data that should be included in the CTD, and propose an effective CTD drafting policy for early approval, while envisioning the final draft package insert from a risk-benefit perspective.
Consultation on strategy making for each PMDA consultation
Effective use of PMDA consultation leads to more efficient development and early approval. We have senior members who have experience in numerous PMDA consultations and have achieved early approvals for many products, and are trusted by the PMDA. Our experienced consultants will propose strategic consultation policies and effective consultation materials.
Consultation on preparing protocol framework of clinical studies
In preparing the framework of a clinical study protocol, the key point is whether or not it is possible to construct a consistent application strategy from non-clinical studies to pivotal clinical trials, including the clinical trial in question. We have experienced consultants who, as development project leaders at major pharmaceutical companies, have led projects from the initial research phase to pivotal clinical trials and have succeeded in obtaining regulatory approval. We will propose an efficient clinical study protocol framework strategy based on non-clinical study results and clinical study results already obtained.
Testimonials
We have always received prompt and appropriate responses to our urgent requests. Not only did they show us the way to establish a pharmaceutical strategy and how to deal with the PMDA, but they also taught us from one to ten how to do it to those who have no experience in this type of work, without leaving any stone unturned, which is the philosophy of Medical Grown, “passing on the heart and skills.” The consulting service is not just a one-size-fits-all consulting service. We have received detailed guidance on the PMDA’s habitual wording and how to deal with the PMDA reviewers (negotiation), which has not only helped us to succeed in our consulting services, but also improved our own skills. In addition, in our daily interactions with him, we have learned about his good personality and the important things in life, which has made us say, “With Dr. Nomura here, I can do my work today with peace of mind! He is like a stabilizer and a good-luck charm for us. We hope to have a long-lasting relationship with Medical Grown in the future.
（A customer who asked regulatory consultation）
As a specialist in CMC and quality, I have received advice on PMDA consultations. He provides very reassuring support to our inexperienced regulatory affairs staff by explaining in an easy-to-understand manner not only how to prepare specific consultation materials and consider issues of concern, but also the intentions of the regulatory authorities based on his wealth of experience and his thinking with an eye toward post-approval filing. He is honest when he discusses matters that are slightly outside of his area of expertise, and even then he explains his thinking clearly based on his own research and experience, so I never feel uneasy. I am rather charmed by his unassuming and gentlemanly personality, and I even look forward to the web meetings I participate in while being comforted by Mr. K.M.’s voice. We hope that he will continue to provide us with guidance through his personality and delicate viewpoint.
（A customer who asked CMC consultation）
