Regulatory Operations

Medical writing

We offer total support with one-stop services. With a combination of writing and regulatory operation support services, we can make efficient and optimal proposals for submission to the authorities.

CDISC standardization support services

We provide support for consultation on CDISC models, creation of clinical database, conversion of data, etc. based on CDISC SDTM.

eCTD Compilation and Submissions via Gateway

Based on the experience in supporting creation of archiving copies of eCTD, we offer complete off-site outsourcing service for the first time in the industry.

eCTD compilation system implementation support

We provide wide range of services from the development of eCTD compilation process, system implementation and validation, to the operations after implementation.

Public document masking service

We provide masking service for the eCTD documents which will be published as regulatory review information of the prescription drug, as well creation of a statement of reasons. We provide quick and efficient support even within a fixed period or tight schedule, using the tool developed for this service.

SEND dataset creation service

Ensure accurate and timely creation and verification of SEND datasets and Define.xml. We can also provide you with support for preparation of the Nonclinical Study Data Reviewer’s Guide.

SWIFTeS – Tool for support of NDA document creation

By using Microsoft Word templates that assist creation of eCTD documents, users can create application documents more smoothly in compliance with eCTD specification.

SWIFTeS Proof – Microsoft Word Text Proofreading Tool

SWIFTeS Proof is a simple, cost-effective tool to solve a problem with ensuring a level of word and sentence consistency throughout your documents.

ToolBox – PDF processing tool

PDF processing tool provided by DXC.tecnology with a proven track record in the US and Europe. By simply adding plug-ins to Acrobat, users can access functions used at pharmaceutical companies around the world.

Publisher – Publishing system

A publishing system provided by DXC.tecnology with a proven track record in the US and Europe.

eCTDXPress – eCTD compilation system

eCTD compilation system provided by DXC.tecnology with a proven track record in the US and Europe. In Japan too, eCDXPress holds a top class share in the eCTD tool category.

DSIMS (NSDS/SWP/ToxVision) – SEND data conversion solution

DSIMS is our fully integrated solutions to prepare and convert nonclinical study data into CDISC SEND datasets. Using this system, you can assess SEND datasets in the same way the FDA does.

Electronic assessment and consulting services

Full support for process maintenance required to handle the next generation of electronic submissions from CDISC formatted data creation to eCTD compilation and gateway submission.

Consulting and outsourcing service of global regulatory submission

We support global regulatory submission in liaison with overseas consultants and vendors of wide experience.

CSV consulting services

We can propose a plan optimized to meet your system size or risk concerns based on our extensive experience. You can choose from a wide range of system lifecycle services from system implementation and preparation through to the operational phase and disposal.

CSV support service for system implementation

Support for validation in implementing systems such as for clinical development, pharmaceutical application, postmarketing surveillance, and pharmacovigilance.

Medical Science Services for Real World Data Study

We provide medical science services for real world data study in all processes involved in developing and conducting a protocol (framing a hypothesis, designing study, analysis, and writing papers) as follows.