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Regulatory and technical program management and submission document preparation


Regulatory and technical program management and submission document preparation

There are many critical decision points in the drug development process. Our Regulatory and Technical Program Management (RTPM) and Regulatory Affairs (RA) teams could provide clients comprehensive solutions and directly address their questions and concerns during R &D.


We are here for you:

  • To ensure IND submission succeeds without insufficient or inappropriate nonclinical data
  • To ensure IND package to meet more than one jurisdiction requirements, eg. FDA, CFDA, and other regulatory authorities’ requirements, with the best regulatory strategy, the most cost effective approach, and the shortest timeline
  • To identify issues early during the process in order to make adjustments in time without losing time or money
  • To provide the professional and prompt consultation or guidance during this dynamic process to assure the success

In summary, our teams of professionals will increase insights into early drug development, which can facilitate clients to uncover potential risks and opportunities, efficiently answer their arise questions, resolve their issues at the beginning and during the process, and ultimately, mitigate risk to assure your success.

 

Here are what we can do for clients during drug R & D process:

 

Initiation & Evaluation
  • Collect the compound’s information to evaluate if the project is suitable to start IND-enabling studies or if pre-IND supports come first. 
  • Establish a mutual trust relationship with clients.
Custom- Built Packages
  • Identify the right strategy for unique program .
  • Select the right IND –enabling studies to fit regulatory requirements –based on the compound’s nature, clinical indication, intended clinical trial regime, data from previous studies, and the jurisdiction(s) that intend to submit.  

No more and no less than what the project needs to save the cost and time!

Multiple Study Designs

RTPM will coordinate with internal (and external if necessary) expertise to provide appropriate study designs in all the package studies. Our professional and constructive suggestions and consultations will facilitate sponsors making the final decisions for all the study design and ultimately, making successful submissions

Scientific Monitoring Process
  • Continuity is essential to the success of the program. RTPM will be with you at every stage.
  • RTPM will scientifically monitor all the process starting from lead optimization, pharmacology, DMPK, CMC, safety assessment, all the way through IND/CTA submission.
Dynamic Study Result Discussion and Consultation

Based on the collected updating data/results, RTPM will continually tune up the studies and process during the progress of project for the best outcome.

Integrate Individual Study Reports

RTPM will coordinate with internal scientists to harmonize all data and results in the reports from different areas to deliver constant products in order to meet regulatory requirements.

Submission Documents Preparation
  • RTPM, joined with Regulatory Affairs team under the same umbrella, prepare the regulatory submission documents for clients, from CMC, pharmacology, ADME, to safety assessment, we all prepare for you.
  • RTPM, joined with our clinical development team, will select the first-in–human (FIH) dose based on the nonclinical data, and to prepare clinical trial Phase I protocol, which are all required by complete IND packages
Advance Continuous Support for Clinical Develop

RTPM will continuously support your clinical development as required, to provide nonclinical support for issues arise from clinical trials. With RTPM, you benefit from the retained knowledge from nonclinical study results and interpretation of potential findings to move your compound across phases more effectively.