Services
Regulatory Affairs
Full support by Regulatory Affairs (RA) specialized consultants
As a CRO with many years of rich integrated experience and having to have the know-how, SRD will respond flexibly to all of the needs, from total support to pinpoint services.
01. Main service contents (RA for Medical devices)
We offer a range of services tailored to the needs of our customers, including support for new entrants from other industries, drafting of regulatory strategies and drafting of regulatory applications.
02. Main service contents (RA for Pharmaceuticals)
CMC related support services
- • Registration of Japanese Drug Master File (J-DMF)
Preparation of registration application forms and In-Country Caretaker services for drug substances - • Accreditation of Foreign Manufacturers (AFM)
Preparation of applications for accreditation (new/renewal) and change notifications, and In-Country Agent services. - • Support for GMP compliance inspection
Regulatory affairs consulting
- • Consulting on regulatory application strategy
- • Support for the various consultations to PMDA
- • Planning of clinical trial in cooperation with Clinical Development department
- • Support for obtaining Marketing Authorization Holder License
- • Support for preparation of GQP/GVP related documents
- • Support for preparation of Marketing Authorization Applications
- • Support for preparation of CTD
- • Consulting on quasi-drugs, cosmetics, etc.
