Q1 How will GCS provide support to development CMC of regenerative medicine
products in Japan ?
A1 From compatibility with a standard of biological ingredients, GCS provide
support to evaluate the ingredients and establish
adequate process control and spec & test method. In addition, GCS
will provide to stability test plan of regenerative
medicine products to secure starting clinical trials and submission
timely.
Q2 How will GCS provide support to conduct PMDA regulatory strategic meeting
?
A2 GCS will instruct items which should be noted regarding quality (CMC)
and non-clinical safety of regenerative medicine
products before face to face advice by PMDA in regulatory strategic
meeting. In adittion, GCS will provide support to
prepare clinical syudy protocols and to cretae PMDA meeting documents
along with countermeasures of PMDA inquires.
Q3 How will GCS provide support to FDA Pre-IND on regenerative medicine products ?
A3 GCS will identify the subjects to be solved by assessment and provide
the countermeasure of them when the FDA Pre-IND
Meeting. In addition, GCS will provide support of a series of process
as follows;
1. Preparation of documents to be submitted to FDA
2. Countermeasure of FDA inquires
3. Attendance at the meeting
Q4 What kind of regenerrative medicine products will GCS provide development
and support ?
A4 GCS will provide support clinical research of the project of university-originated
regenerative medicine products and
regenerative medicine products introduced from overseas to develop within
Japan by companies. This development
support means that countermeasure based on a series of CMC evaluation
of regenerative medicine products,
manufacturing for investigational regenerative medicine ptoducts and
their quality control based on a series of evaluation.
Q5 Would GCS provid edevelopment and support of the combination product composed
of regerative product and medical
device?
A5 Administration route of regenerative medicine products depend on the formulation.
Topical transplantation, intravenous
administration and local administration by interventional therapy, etc.
are conducted. Particularly, local sdministration by
interventional therapy is combined by specially controlled medical devices
utilized catheter technology and regenerative
medicine products.
GCS will provide support development of such a combination product concentrating
abilities of medical device expert and
RM CMC expert with their high skills. GCS will comply with a guideline
of application procedure for approval on
combination products, which was issued on 24th October, 2014.
Q6 Would GCS provide development and support of biopharmacetical and/or low molecular pharmaceutical products?
A6 GCS have originally provided development and support on biopharmaceutical
and low molecular pharmaceutical products.
Experts experienced for long time in Japanese pharmaceutical industry
with high skills (CMC, pharmacology, toxicology,
ADME and clinical pharmacology, clinical affairs) at GCS will provide
development and support of them.
Q7 What kind of scientific experts are at GCS ?
A7 The outline of these scientists is page in About US.