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Regulatory affair

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 support all of the tasks such as paperwork/documents preparation, internal systems construction and approval, in smooth and bias-free manners.

Scope of services (RA consulting)

We receive all the consultations on the regulatory application associated with the domestic market of the product.

  • Consulting on regulatory application strategy
  • Support for the various consultations to PMDA
  • Consulting on internal system construction, such as GQP/GVP/QMS
  • Consulting on support for GMP/QMS/GCTP compliance inspection, planning of non-clinical study, selections (study sites, etc.) and study implementation
  • Suitable support for regulation of regenerative medicine products
  • Planning and implementation of clinical trial in cooperation with Clinical Development department
  • Evaluation of the non-clinical study and clinical trial data
  • RA seminars
    ※ Personalities who have been at the forefront of the industry are invited as lecturers.
  • Various consulting associated with the revision of the Pharmaceutical Affairs Law; Short name for the revised law The Pharmaceuticals, Medical devices and Other Therapeutic Products Act.

Scope of Services (Support for creation of RA documents)

We provide assistance with the creation of a variety of materials based on The Pharmaceuticals, Medical devices and Other Therapeutic Products Act

  • Support for preparation of application for marketing approval for pharmaceutical product or such, and the other related documents
  • Support for preparation of application for marketing approval for medical device, In-vitro diagnostic reagent and the other related documents
  • Support for preparation of application form for Marketing Authorization Holder,Manufacturer,Accreditation of Foreign Manufacturer, etc.
  • Support for preparation of GQP/GVP related documents
  • Support for preparation of GMP/QMS/GCTP related documents, and for preparation of CTD
  • preparation of registration application for Drug Master File and In-Country Caretaker work for drug substances

Main services (services for Medical writing and Safety management )

  • For Medical Writing related services, Click here
  • For Safety Management related services, Click here

Main services (Services for quasi-drugs and cosmetics)

  • Survey on propriety of ingredients
  • Support for the elaboration of application for Quasi-drugs marketing approval

Work flow of preparation support of regulatory application for medical device

Consulting from development to regulatory application for medical device Click here

  • Interviewing for current status of internal systems, developing products, application plan, etc.
  • Verification of the information such as general name, RA requirements, similar products for the developing products
Regulatory affair|Service|SRD
Examination and confirmation of approval
  • Examination, confirmation of the necessary approval and authorization, such as Marketing Authorization Holder License, Manufacturer registration and Foreign Manufacturer Registration.
Regulatory affair|Service|SRD
Confirmation of basic requirements
  • Verification of whether developing products meets the standards of basic requirements for medical devices
  • Examination, confirmation of evaluation test necessity
  • (If necessary) Consulting for selection and coordination of the evaluation testing laboratory, .
Regulatory affair|Service|SRD
Examination of the requirements
  • Examination and confirmation of approval, certification, materials necessary for the notification procedure, etc.
  • Confirmation of whether the display of the label, instruction manual (draft), etc. comply with the Pharmaceuticals, Medical devices and Other Therapeutic Products Act/ JIS, etc.
Regulatory affair|Service|SRD
Establishment of the system for business permit acquisition
  • Confirmation that the office meets the permit requirements
  • Consulting to meet the business permit requirements (if necessary)
Regulatory affair|Service|SRD
Elaboration of procedures, Maintenance of QMS/ GVP
  • Consulting to meet the Quality Management System (QMS) / Good Vigilance Practice (GVP) and Support for elaboration of the required documents for business authorization.
Regulatory affair|Service|SRD
Preparation support of application
  • Preparation support of application such as Marketing Authorization Holder License and Manufacturer License
  • Preparation support of application such as Approval, Certification, Notification to developing products
Regulatory affair|Service|SRD
Support for the correspondence to the authority
  • Consulting concerning on-site audit, written audit that occurs in a variety of procedures, etc.
  • Support for the inquiry correspondence from the reviewer of the authorities
Regulatory affair|Service|SRD
Authorization and certification
  • Various consultation after acquisition of authorization, if necessary

Application of Marketing Authorization Holder License for medical device Click here

  • Interviewing of application plans, current status of internal system, etc.
  • Verification such as office, organizational structure and staffing requirements
Regulatory affair|Service|SRD
Application support
  • Gathering of information and materials required for application-related paperwork
  • Preparation support of application form and attached documents, etc.
  • Preparation support of GQP/ GVP procedures
Regulatory affair|Service|SRD
License application
  • Support services for written audit, site audit and findings, etc.
Regulatory affair|Service|SRD
  • Support for procedures when change in application contents and also for the license renewal.


The reasons why SRD is chosen as a partner.

For those who acquire a work authorization for the first time, we will provide adequate support to guide you through the process.

At the time of contract, we will explain to you the acquisition process and the contents of work authorization that will be acquired. We will advance the preparation of application form with courteous interviews and counseling, so that you can rely on us with confidence, even if it is the first time for you to apply for a work authorization.

Coordination support with foreign manufacturers

If you are dealing with foreign-made products, in addition to the application for your products, it is also required to apply for Foreign Manufacturer Accreditation. In that case, the vast amount of information regarding the products and manufacturing site etc., will require to be gathered from the foreign manufacturer by contacting many times over. For saving time and effort, we will correspond and coordinate with the foreign manufacturer on behalf of our client.

Support for a wide range of services

We will carefully, flexibly and quickly provide you with support for every consultation on RA, from total service of licensing, various internal systems construction, product development/application, response to inquiries from the audit authorities, etc., to a precise service.

We will listen to you carefully and with enthusiasm, in order to make suggestions/ advices according to your position. Whenever, we think strongly to help you even a little with what we can do for what you hope to achieve.As we provide a flexible support, we can also provide services and other works that are not listed in here, please contact us for any questions.