Medical Writing
Our Services
Support for Regulatory Documents
intellim supports you to prepare various documents as per Pharmaceutical Affairs Act.
- From preparation of regulatory documentation (for pharmaceuticals and medical devices) to submission support
- Preparation of DMF（active ingredients, additive and packaging material）, DMF filing to regulatory authorities (PMDA, FDA, EMA and MFDS (KFDA）)
- Translation of regulatory documents
Medical Writing for clinical trial related
intellim supports you to prepare various documents related to clinical trial
- Development and preparation of Protocol, CSR, CTD and other related documents
Scope of Business
[Preparation of various documents related to pharmaceuticals and medical devices (development to application, until PMS)]
| Phase | Scope of Business | Pharmaceuticals | Medical devices |
|---|---|---|---|
| Clinical Trail | Preparation of Standard Operating Procedure (SOP) | ○ | ○ |
| Preparation of IND | ○ | ○ | |
| Development of Protocol | ○ | ○ | |
| Development of master ICF (Informed Consent Form) | ○ | ○ | |
| Preparation of Clinical Study Report (CSR) | ○ | ○ | |
| Preparation of Investigator’s Brochure (IB) (Pharmaceuticals) | ○ | ||
| Preparation of Investigator’s Brochure (IB) (Medical devices) | ○ | ||
| Application | Preparation of CTD (Common Technical Documents) | ○ | |
| Preparation of documents for Manufacturing and Sales license | ○ | ○ | |
| Preparation of documents for Manufacturing license | ○ | ○ | |
| Preparation of application for manufacture and sales approval | ○ | ○ including STED |
|
| Preparation of application for manufacture and sales authorization | ○ including STED |
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| Preparation of application for partial change and notification for change | ○ | ○ | |
| Approval | Preparation of the response to the matters inquired into | ○ | ○ |
| Post-Marketing | Preparation of Post-Marketing Survey sheet | ○ | ○ |
| Preparation of Report for Early Post-marketing Phase Vigilance, Treatment Outcome Study | ○ | ○ |
[Support for import and export of active pharmaceutical main ingredients]
| Scope of Business | Japan | USA | Korea | Taiwan |
|---|---|---|---|---|
| Preparation and filing of Master File (MF) | ○ | ○ | In Preparation | In Preparation |
| Application for Accreditation of Oversea Manufacturer | ○ |
For more information
If you have any comments, questions, please contact us.
