• Business Areas

    Clinical Trial Permission

    To complement your drug development and shorten the time to market, Tigermed offers RA services for both drug products, ranging from small molecules to biologicals and medical devices. Our regulatory experts have years of experiences with theFDA (US), NMPA (China), and the EU health authorities and are very familiar with the differences in local regulatory requirements.They can provide you with feasible strategies and act asliaison withvarious regulatory agencies, both on technical and regulatory issues.

    Registration of Drug Products in China

    ?         Acting as Health Authority liaison

    ?         Feasibility assessment for domestic registration 

    ?         Reviewing and providing guidance for improving the registration dossier 

    ?         Compilation (including translation) and submission of the registration dossier 

    ?         Reviewing specifications 

    ?         Tracking during the registration process

    Registration of Drug Products in Europe, US, and Australia

    ?         Act as a liaison to Health Authorities in the US, Europe and Australia

    ?         Feasibility assessment and registration planning for registration of drug products

    ?         Preparation and filing of DMFs for APIs

    ?         CEP certificate application for APIs and change applications

    ?         Preparation and filing of DMFs and EDMFs for pharmaceutical excipients and packaging materials

    Providing guidance on R&D for registration of drug products and reviewing of the dossier

    Establishing connections for clinical trials

    ?         Reviewing protocols and reports for clinical trials

    ?         Preparation and reviewing of registration dossier for drug products, conversion to eCTD format and submission

    ?         Tracking registration review

    Registration of Health Foods in China

    ?           Imported and domestic health foods

    ?           Technology transfer and technical changes in health food dossiers

    ?           New food raw materials

    Registration of Medical Devices

    ?           Domestic and overseas medical devices and relevant clinical trials

    ?           Domestic and overseas IVD reagents and relevant clinical trials

    ?           FDA 510(K) Certification of medical devices

    ?           EU-CE certification of medical devices

    Registration of Imported/Domestic Cosmetics

    ?         Filing of the license application for imported cosmetics

    ?         Filing of the license application for domestic cosmetics for non-special uses

    ?         Filing of the license application for domestic cosmetics for special uses

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