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Medical & isẹgun nwon.Mirza

Medical & isẹgun nwon.Mirza

Ni CSC a loye bawo ni dukia rẹ ṣe ṣe pataki si ọ ati idi ti ikuna kii ṣe aṣayan. Ṣaaju ki ibẹrẹ ti iwadii ile-iwosan, paapaa fun igba akọkọ, iwọ yoo dojuko pẹlu awọn ibeere sisun ti a le ṣe iranlọwọ fun ọ lati wa idahun si

    Pe wa
    ọja alaye
    ọja apejuwe

    apejuwe1

    apejuwe2

    • Medical & isẹgun nwon.Mirza

      Awọn agbara Kikọ Iṣoogun kọja Igbesi aye Idagbasoke Ile-iwosan ni kikun

    Idi

    Ẹgbẹ kikọ iṣoogun wa ti pinnu lati tumọ alaye imọ-jinlẹ eka sinu awọn abajade ilowo pẹlu ibamu ilana ni kikun, mu ilọsiwaju idagbasoke oogun pọ si nipasẹ apẹrẹ ikẹkọ ile-iwosan ti aipe ati awọn iwe kikọ ti o dara julọ, idinku akoko ti o nilo lati mu oogun naa wa si ọja.

    Eniyan

    A ni awọn amoye ọjọgbọn ni Ilu China ati AMẸRIKA pẹlu imọ ti awọn ilana agbegbe ati oye ti o jinlẹ ti awọn ẹya ọja.

    10+ ti o ni oye pupọ ati awọn onkọwe ti o ni iriri pẹlu ipilẹ iṣoogun.

    Awọn agbara

    Dagbasoke deede, ko o, ati awọn iwe aṣẹ ibamu gẹgẹbi fun iṣẹ akanṣe ati awọn ibeere ilana.

    Iṣeto rọ lati ṣakoso ati mu idagbasoke idagbasoke iwe lati pade awọn akoko akoko.

    Awọn SOP ti o jẹ asiwaju ile-iṣẹ ati iriri iwosan ti o jinlẹ.

    Atilẹyin kikọ iwe iṣoogun leta lati awọn iwe aṣẹ kọọkan si awọn eto kikọ iṣoogun lọpọlọpọ.

    Eto ikẹkọ pipe lati rii daju ilọsiwaju igbagbogbo ti ẹgbẹ iṣoogun.

    Iriri

    Oncology: Immunotherapy, Monoclonal Antibodies, Itọju oogun ti a fojusi, Itọju Ẹjẹ ati al. fun ri to tumo & hematology.

    Awọn arun autoimmune: SLE, Psoriasis, Vifiligo, RA, AD, asthma, et al.

    Arun ti iṣelọpọ: Àtọgbẹ, Isanraju iwọn apọju, NASH, NAFLD, et al.

    Awọn arun CNS: Parkinson, Arun Alzheimer, Arun Guillain-Barre, et al.

    Fẹnukonu, Irora, et al.

    • Pẹlu awọn akitiyan apapọ ti awọn ẹgbẹ ijumọsọrọ ile-iwosan ati iṣoogun & awọn amoye oogun, a ni:

      Awọn apẹrẹ Ilana ti a firanṣẹ fun awọn idanwo ile-iwosan ti ọpọlọpọ-agbegbe (MRCT) ati awọn ifọwọsi IND ni Ilu China ati AMẸRIKA, ni aaye Oncology (solid & hematology) ati agbegbe autoimmune.

      Gba igbanilaaye ti Apẹrẹ Adagba Ipele II/III tabi apẹrẹ apa kan nipasẹ ibaraẹnisọrọ EOP2 lati mu idagbasoke idanwo ile-iwosan pọ si.

    akoonu iṣẹ

    Ifakalẹ IND:Ibaraẹnisọrọ Pre-IND, Ilana, CDP, IB, ICF, Akopọ Ile-iwosan (module 2.5), Akopọ Ile-iwosan (module 2.7), ati RMP.

    Ipele I~III iwadi:Ilana, · IB, · CSR, Iroyin SAE, Ipade oniwadi, Itumọ Ilana fun ẹgbẹ iṣẹ.

    Ipade EoP2 (Ibaraẹnisọrọ pẹlu CDE ṣaaju ikẹkọ pataki): Fọọmu Ibaraẹnisọrọ Apejọ, Awọn ohun elo Ibaraẹnisọrọ Apejọ.

    Ifisilẹ NDA:Ibaraẹnisọrọ Pre-NDA, Akopọ Iwosan (module 2.5), Akopọ Isẹgun (module 2.7), ISS & ISE, RMP, Iroyin Asopọmọra Asopọmọra Ẹya (Iforukọsilẹ wọle).

    Ikẹkọ ipele IV:Ilana, · CSR, Aabo Oògùn lẹhin-ọja.

    Iwadi IIT:Ilana, CSR, Iroyin SAE, Ipade oniwadi, Itumọ Ilana fun ẹgbẹ iṣẹ.