Delays in product registration can cause a huge loss in market potential. Many clients consider the value of the regulatory consultation as a key to drug registration and market access. Our consulting experts on pre-submission and strategic approach provide clients with clear action plans to achieve the desired drug registration outcome.
Highly experienced consultants fully support everything from consulting on drug development planning to drug registrations. We provide reliable support based on extensive experience with in-country clinical caretakers and clinical trial consulting. We provide comprehensive support for handling eCTD compilation, electronic applications, and computerized regulatory requirements. Our systems comply with CDISC standards.
A full range of regulatory consultation services that are your assurance of successful clinical trials.
- Clinical planning
- -Design development strategy, formulate clinical trial plan, and perform clinical development consulting, including on biosimilar and regenerative medicines
- -Support for PMDA clinical trial consulting (pre-interview and face-to-face meetings) and drug strategy consulting
- -Provide comprehensive support for approval applications based on CDISC standards
- Regulatory affairs
- -Consult on regulatory affairs and work on investigational drugs (labels, packaging materials, and delivery)
- -Consult on dealing with eCTD compilation, electronic applications, and computerized regulatory requirements
- -Consult on general pharmaceutical affairs business, CMC regulatory affairs (drug master file and foreign manufacturer accreditation including for pharmaceuticals), etc.
- In-country clinical caretaker
We will tailor an ideal solution for your specific needs.