Regulatory Service and Clinical Operation for Drug Development

Category: *CRO

Exhibitor: EFFICIENT PHARMA MANAGEMENT CORP.

Booth No: M820

Characteristic

Efficient Pharma Management Corp. (EffPha) has designed a complete range of services to meet the needs of drug development from drug evaluation consulting, execution planning, and regulatory submission to clinical trial management. The scope of services includes regulatory application services, clinical trial design and monitoring, and consulting services. EffPha provides professional consulting and management capabilities to help clients shorten development time and reduce risks.

1. Regulatory Services
In terms of regulatory services, EffPha provides document writing, information integration, and submission for new drug applications. After reviewing and evaluating the relevant technical documents provided by the client, the EffPha team integrates information from different fields to complete the writing of submission documents. Regulatory services related to new drugs include Investigational New Drug (IND) applications, drug registration of medicinal products (NDA, BLA, biosimilars), foreign plant master file (PMF), post-approval change, and related document preparation and submission, as well as consultation meetings with health authorities. EffPha is capable of providing regulatory services in both Taiwan and the United States.
In addition, electronic submission has become a trend for new drug regulatory applications worldwide. EffPha uses an eCTD system that meets the requirements of the US FDA to compile, publish, and validate clients' submission documents. By using the electronic submissions gateway (ESG) integrated with the US FDA system, e-submission is carried out.

2. Clinical Trial Design and Monitoring
EffPha's clinical operation team can provide clients with high-quality, efficient, and comprehensive clinical research services, covering various types of cases, including clinical study protocol design and writing, case report form (CRF), informed consent form (ICF), clinical site/ principal investigator (PI) evaluations, and submission to the institutional review board (IRB). In accordance with the GCP and clinical study protocol for monitoring the trial process, design a statistical analysis plan (SAP), conduct statistical analysis, and write up clinical study reports.

3. Technical Consulting Services
EffPha can provide technical consulting services to help clients solve technical problems encountered during the development process, such as difficulties in chemistry, manufacturing and control, pharmacokinetics/pharmacodynamics, toxicology, clinical trial design, and statistical analysis. EffPha's technology team is composed of experts with decades of experience in international pharmaceutical companies, providing comprehensive knowledge and technical services.