{"id":8671,"date":"2020-04-13T20:38:16","date_gmt":"2020-04-13T20:38:16","guid":{"rendered":"http:\/\/box5506.temp.domains\/~direxaco\/?page_id=8671"},"modified":"2020-08-22T13:08:00","modified_gmt":"2020-08-22T17:08:00","slug":"services","status":"publish","type":"page","link":"https:\/\/direxaconsulting.com\/?page_id=8671","title":{"rendered":"SERVICES"},"content":{"rendered":"

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Services<\/h1>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.4.4″ background_color=”#f7e0a5″][et_pb_row column_structure=”2_3,1_3″ custom_padding_last_edited=”on|desktop” _builder_version=”4.4.3″ background_color=”rgba(0,0,0,0)” custom_margin=”||||false|false” custom_padding_tablet=”” custom_padding_phone=””][et_pb_column type=”2_3″ _builder_version=”4.4.3″ background_color=”rgba(0,0,0,0)” custom_padding=”50px||50px||true|true” custom_padding_tablet=”” custom_padding_phone=”|25px||25px|true|true” custom_padding_last_edited=”on|phone” border_width_all=”1px” border_color_all=”#e2e2e2″][et_pb_text admin_label=”Heading Text Services” _builder_version=”4.5.7″ header_font=”Prata||||||||” header_2_font=”Prata||||||||” header_2_font_size=”48px” custom_margin=”-60px||||false|false” hover_enabled=”0″ header_4_font=”Prata||||||||” header_4_font_size=”30px”]<\/p>\n

Recent projects include work in these areas:<\/span><\/strong><\/h4>\n

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Develop and build statistical strategy for process and analytical development, scale-up, validation and ongoing monitoring.<\/strong> <\/span><\/p>\n

Areas of specialty include:<\/span><\/strong><\/p>\n

    \n
  • Quality by Design<\/span><\/li>\n
  • Justification of specifications<\/span><\/li>\n
  • Stability study design & analysis<\/span><\/li>\n
  • Estimation of shelf life & internal release limits<\/span><\/li>\n
  • Control strategy development<\/span><\/li>\n
  • Biological assay statistical design including cell-based potency assays<\/span><\/li>\n
  • Reference standard qualification & bridging<\/span><\/li>\n
  • Process characterization<\/span><\/li>\n
  • Statistical Design of Experiments (DoE)<\/span><\/li>\n
  • Formulation (mixture) experiments design and analysis<\/span><\/li>\n
  • Robust process & product design<\/span><\/li>\n
  • Multivariate modeling of starting materials and process performance<\/span><\/li>\n
  • Analytical method development, qualification & validation<\/span><\/li>\n
  • Comparability protocol and criteria<\/span><\/li>\n
  • Process validation strategy<\/span><\/li>\n
  • Continued Process Verification (CPV)<\/span><\/li>\n
  • Deviation investigation & resolution<\/span><\/li>\n
  • Independent 3rd <\/span>party review of data packages to support submissions<\/span><\/li>\n<\/ul>\n

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    Webinar:
    Accelerating Drug Commercialization<\/span><\/strong><\/h4>\n

    Slide presentation
    with voice over.<\/span><\/p>\n

    \u00a0<\/span><\/p>\n

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    ServicesRecent projects include work in these areas: Develop and build statistical strategy for process and analytical development, scale-up, validation and ongoing monitoring. Areas of specialty include: Quality by Design Justification of specifications Stability study design & analysis Estimation of shelf life & internal release limits Control strategy development Biological assay statistical design including cell-based potency […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"footnotes":""},"class_list":["post-8671","page","type-page","status-publish","hentry"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t