Consultant

Our consultants serve in strong partnership with clients to offer assistance in diverse areas, including drafting development strategies, responding to inquiries from authorities, preparing application documents, and obtaining approvals.
 

  • Regulatory Affairs
  • Research and Development (R&D)
  • Regenerative Medicine and Tissue Engineering
  • Chemistry, Manufacturing and Control (CMC)
 
Regulatory Affairs (RA) Consultant

A

Experience R&D in bio and antibody pharmaceuticals, clinical trials management and application dossier processing for approval at the Japanese pharmaceutical company.
Specialty QA, RA and GCP inspection.

Regulatory Affairs (RA) Consultant

B

Experience Long experience in RA and whole range of pharmaceutical development from basic research to clinical trial at the major foreign pharmaceutical company. Published many papers on respected magazine such as “Nature”.
Specialty Cardiovascular disease, metabolic disease

Regulatory Affairs (RA) Consultant

C

Experience Pharmacist. Whole range of RA experience at the major Japanese pharmaceutical company.
Specialty RA including NDA

Regulatory Affairs (RA) Consultant

D

Experience R&D, RA and project management at the major foreign pharmaceutical company (more than 25 years).
Specialty Digestive system, cardiovascular system, respiratory system and CNS

Regulatory Affairs (RA) Consultant

E

Experience Pharmacist. Basic research, R&D, project management and RA at the major foreign and the Japanese pharmaceutical company.
Specialty Application dossier processing for approval and authority consultation support
Research and Development (R&D) Consultant

F

Experience Ph.D. (Pharmacology). R&D and medical affairs at the major Japanese pharmaceutical company.
Specialty Immunity, inflammation, allergy, cancer. Research paper writing. Research paper processing strategy consultation and researching service.

Research and Development (R&D) Consultant

G

Experience Ph.D. (Pharmacology) and Pharmacist. R&D of new drug at the major Japanese new-drug pharmaceutical company. Long experience in PK, clinical pharmacology studies, joint R&D with western new-drug pharmaceutical company and global development.
Specialty Clinical pharmacology, Japanese and non-Japanese NDA and joint R&D with foreign pharmaceutical company

Research and Development (R&D) Consultant

H

Experience R&D at the major foreign pharmaceutical company
Specialty Non-clinical trial application form processing, protocol processing, clinical trial related application form processing, monitoring, pharmaceutical development and negotiation with authority on new drug development of CNS, orthopedics, dermatology, hemodialysis, infectious diseases, cardiovascular and blood medicine.

Research and Development (R&D) Consultant

I

Experience R&D, RA, medical writing and marketing at the major Japanese and the foreign pharmaceutical company.
Regenerative Medicine and Tissue Engineering Consultant

M

Experience R & D and clinical development in the pharmaceutical department of the chemical fiber manufacturer. Basic research, clinical development and application dossier processing for approval in the development of protein products of serum and coagulation fibrinolytic and therapeutic agents for dysuria disorder. Officer of PMDA R&D and RA strategy consultation department: consultant for academia and venture company of regenerative medicine, tissue engineering and gene therapy for 5 years.
Specialty Protein formulations of serum and coagulation fibrinolytic, therapeutic agents for dysuria disorder, regenerative medicine and tissue engineering
Chemistry, Manufacturing and Control (CMC) Consultant

N

Experience Ph.D. (Engineering). Basic Research at Japanese pharmaceutical company, Director of preclinical development at the foreign pharmaceutical company. After this experience, established his own biopharmaceutical venture company for gene therapy.

Chemistry, Manufacturing and Control (CMC) Consultant

O

Experience Ph.D. (Pharmacology). Deputy director of the analytical laboratory at the Japanese pharmaceutical company.

Chemistry, Manufacturing and Control (CMC) Consultant

P

Experience Ph.D. (Engineering). Director of production technology research institute at the Japanese pharmaceutical company.

Chemistry, Manufacturing and Control (CMC) Consultant

Q

Experience Deputy plant manager and quality control officer of analytical research institute at the Japanese pharmaceutical company.

Chemistry, Manufacturing and Control (CMC) Consultant

R

Experience Ph.D. (Engineering). Deputy director of research institute at the Japanese pharmaceutical company.
 
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