REGULATORY

AFFAIRS

MediHelpLine provides comprehensive range of regulatory consulting services across of pharmaceutical and medical product development programs with regulatory requirements and commercialization. With regulatory experience in all areas of pharmaceuticals including medical device, herbal medicine and dietary supplement, MediHelpLine regulatory experts provide intelligence and strategic insight for development and strategic planning, execution and achievement of successful product registration with regulatory authorities in local and global.
Service Consulting

- Development and registration strategies of drug and medical device 

- Data review, gap analysis and strategic advice

- Documentation and presentation coaching expert report preparation

- Specific consulting strategies (e.g.  drug,  medical device, biosimilar, IVD, orphan)

- Risk management planning

- Response to agency queries and meeting the regulatory Agency

- Advisory committee preparation

- Feasibility market research

- Develop international regulatory strategic plans for each stage of development

- GMP inspection consulting 

Medical Writing & Document Publishing

- Development, preparation, assembly and submission of complete

  Common Technical Documentation (CTD) & Summary Technical Documentation (STED)

- Life cycle document management system

- Conversion of paper documents into electronic dossiers using e-CTD 

- Processional medical writing services: Investigator brochures, Clinical trial protocols,

  Risk Evaluation and Mitigation Strategy (REMS) & PMP, Periodic Safety Reporting, CMC, Non-clinical 

- Preclinical, Clinical, and CMC coordination and document management

- Translation service

Regulatory Submissions & Applications

- Dossier/submission preparation or review and filing 

 * Drug & Quasi-Drug registration: IND/NDA/DMF

 * Medical Device  and IVD Product Registration: Preparation of technical files , CE Marking , 510(k), 

    PMA

- Reimbursement Listing

Quality Assurance/Training Service

- Customized training program

- Customized life cycle documentation management system development

Post-Approval Life Cycle Maintenance

- Renewals

- Annual reporting

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Global  Healthcare  No.1