Knowledge of regulatory affairs is crucial to the success of a clinical trial. Over the past few years, complex systems have been put in place to effectively regulate the marketing of medical interventions, leading to widespread collaboration between regulatory authorities, research scientists, clinicians, biotech companies, and pharmaceutical companies in sharing important data on medical products and clinical trials. This includes data on approval processes, clinical practice guidelines, quality assurance, and ethical aspects concerning the safe treatment of human subjects, informed consent, pharmacovigilance, data privacy, and the responsibilities of various stakeholders. Regulatory affairs professionals help liaise between companies and regulatory agencies by managing, compiling, and submitting data, which is then used by
by authorities in deciding whether a product should be on the market and how it should be marketed and sold.
Feasibility
Clinixir’s professional team will evaluate current regulations and analyze the impact of recent or potential changes, evaluate the registration pathways, timelines, fees, documentation requirements, and intricacies and country/ region specific needs.
Our services includes:
- Drugs
- Vaccines
- Medical Devices
Health Authority Consultation
Clinixir’s advisory team will work with you to navigate complex regulatory requirements and stay ahead of any compliance risks, all while liaising on your behalf with the relevant health authorities.
Clinical Trial Support
Clinixir will provide consultation throughout every stage of your clinical trial to ensure that all processes meet the latest regulatory developments and requirements. Compliance with regulation involves the proper management, maintenance, and verification of test sites, as well as the safeguarding of patients involved in clinical trials.
IND Submission
An IND application is a request for authorization to administer an investigational drug or biological product to humans. It is used in a clinical trial to investigate the drug’s safety and efficacy. Clinixir is familiar with the procedures and requirements that govern the IND approval process, ensuring that they meet local regulatory requirements.
NDA Submission
Following the Phase III Clinical Trials, Clinixir’s regulatory team will assist you in delivering a complete and accurate NDA submission that meets Thai FDA regulatory requirements. The NDA contains all of the data gathered to date about the drug.
As NDAs are formal requests to market the drug, this step occurs after all data demonstrate the drug’s safety and effectiveness.
Clinical Development Plan
Clinixir will offer tailored guidance to help you bring your novel drug development to market through clinical and regulatory support. A well-designed and documented clinical development plan will ensure that your clinical trial is on the right path. Our team will provide resources and cost estimates, and plan the progression of your clinical trials and strategies in accordance with medical, regulatory, and marketing considerations, while also compiling data on the safety and effectiveness of each drug or treatment method.
