{"id":20,"date":"2022-08-28T06:40:53","date_gmt":"2022-08-28T05:40:53","guid":{"rendered":"https:\/\/www.ceutiqus.com\/bam\/?page_id=20"},"modified":"2023-05-03T18:01:00","modified_gmt":"2023-05-03T17:01:00","slug":"services","status":"publish","type":"page","link":"https:\/\/www.ceutiqus.com\/bam\/services\/","title":{"rendered":"Services"},"content":{"rendered":"

[et_pb_section fb_built=”1″ _builder_version=”4.19.2″ _module_preset=”default” background_color=”rgba(0,0,0,0.48)” background_image=”https:\/\/www.ceutiqus.com\/bam\/wp-content\/uploads\/2022\/12\/Help-and-support-scaled.jpg” background_blend=”overlay” custom_margin=”||-149px|||” custom_padding=”0px||366px|||” global_colors_info=”{}”][et_pb_row _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”-76px|auto||auto||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.18.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” header_font=”|700||on|||||” header_text_align=”center” header_text_color=”#FFFFFF” header_font_size=”40px” header_line_height=”1.2em” custom_margin=”-18px|||||” header_font_size_tablet=”40px” header_font_size_phone=”30px” header_font_size_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Services<\/h1>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.19.4″ _module_preset=”default” custom_padding=”82px||42px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.19.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.4″ _module_preset=”default” header_line_height=”1.2em” custom_padding=”126px||0px|||” global_colors_info=”{}” custom_margin=”||-79px|||”]<\/p>\n

ATMP QP SERVICES<\/span><\/strong><\/span><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.18.0″ _module_preset=”default” custom_margin=”40px|||||” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″][et_pb_row _builder_version=”4.20.0″ _module_preset=”default” custom_margin=”62px|auto||auto||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.20.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.18.0″ _module_preset=”default” text_font=”|600|||||||” text_font_size=”20px” text_line_height=”0.4em” text_orientation=”center” custom_margin=”-45px||14px||false|false” custom_padding=”||26px|||” global_colors_info=”{}”]<\/p>\n

Biological & Advanced Therapy Medicinal Product (ATMP) <\/span><\/p>\n

Qualified Person (QP) Services<\/span><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ use_custom_gutter=”on” gutter_width=”2″ make_equal=”on” _builder_version=”4.18.0″ _module_preset=”default” width=”90%” max_width=”2560px” custom_padding=”16px|||||” locked=”off” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.18.0″ _module_preset=”default” custom_padding=”50px|20px|50px|20px|true|true” box_shadow_style=”preset1″ box_shadow_color=”rgba(71,71,71,0.18)” global_colors_info=”{}”][et_pb_blurb title=”ATMP Expert Consulting that gives you the greatest return on investment (ROI)” use_icon=”on” font_icon=”||divi||400″ icon_color=”#962141″ image_icon_width=”50px” _builder_version=”4.19.4″ _module_preset=”default” header_font=”|700|||||||” header_text_align=”center” header_font_size=”18px” body_text_align=”center” body_font_size=”16px” global_colors_info=”{}”]<\/p>\n

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

<\/span><\/span>We will provide you expert support with:<\/span><\/span><\/p>\n

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

Product & Process Design & Development<\/span><\/strong><\/p>\n

Quality by Design (QbD)<\/span><\/strong><\/p>\n

Chemistry, Manufacturing and Control\u00a0 \u00a0 \u00a0 <\/span>\u00a0 \u00a0(CMC)<\/span><\/strong><\/p>\n

Technology Transfer<\/span><\/strong><\/p>\n

Regulatory submissions (BLA, MAA, IND, CTA)<\/span><\/strong><\/p>\n

Environmental risk assessments for GMOs<\/span><\/span><\/strong><\/p>\n

Facility design<\/span><\/strong><\/p>\n

Quality Management Systems (QMS) Development & Management<\/span><\/strong><\/span><\/p>\n

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

We have supported the design and development of a large variety of biologicals and advanced therapy medicinal products (ATMPs); their processes and also their facilities to ensure the most favourable balance of future-proof operational efficiency, compliance and patient safety.<\/span> <\/span><\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.18.0″ _module_preset=”default” custom_padding=”50px|20px|50px|20px|true|true” box_shadow_style=”preset1″ box_shadow_color=”rgba(71,71,71,0.18)” global_colors_info=”{}”][et_pb_blurb title=”ATMP Qualified Person (QP) Services & Quality Leadership” use_icon=”on” font_icon=”||fa||900″ icon_color=”#962141″ image_icon_width=”50px” _builder_version=”4.18.0″ _module_preset=”default” header_font=”|700|||||||” header_text_align=”center” header_font_size=”18px” header_line_height=”1.3em” body_text_align=”center” body_font_size=”16px” global_colors_info=”{}”]<\/p>\n

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We provide Qualified Person (QP) services and site leadership for advanced therapy medicinal products (ATMPs), such as cell therapy, gene therapy and tissue engineering in the UK and EU. <\/span><\/span><\/p>\n

We have QP certified hundreds of biological and ATMP product types for over a decade. <\/span><\/span>Our leading niche within ATMPs is in ocular ATMPs (including cell therapy, gene therapy, tissue engineering and regenerative medicine (TERM)). <\/span><\/span><\/p>\n

We offer full life-cycle support from early research through to large-scale commercial manufacturing. We\u2019re experienced at dealing with scientific and regulatory uncertainty and working at the cutting-edge. <\/span><\/span><\/p>\n

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

We have helped many organisations from the earliest concept stages through to global commercial manufacture. <\/span><\/span><\/p>\n

We offer free consultations to discuss your particular needs.<\/span><\/strong><\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.18.0″ _module_preset=”default” custom_padding=”50px|20px|50px|20px|true|true” box_shadow_style=”preset1″ box_shadow_color=”rgba(71,71,71,0.18)” global_colors_info=”{}”][et_pb_blurb url=”https:\/\/www.ceutiqus.com\/bam\/investing\/” use_icon=”on” font_icon=”||fa||900″ icon_color=”#962141″ image_icon_width=”50px” _builder_version=”4.20.0″ _module_preset=”default” header_level=”h2″ header_font=”|700|||||||” header_text_align=”center” header_font_size=”18px” body_text_align=”center” body_font_size=”16px” global_colors_info=”{}”]<\/p>\n

ATMP Angel Investing and ATMP Company Building<\/h4>\n

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

We are A<\/span>ngel Investors, company builders, industry experts and technology co-developers in ocular, biological, regenerative and advanced therapy medicinal products (ATMPs: cell therapy, gene therapy, tissue engineering).<\/span><\/p>\n

We invest in great science that has the potential to make significant impact to our patients’ unmet medical needs.<\/span><\/span><\/p>\n

We’re particularly interested in meeting, supporting and partnering with founders and innovators with promising technology to build impactful companies that will innovate life-changing future medicines for unmet medical needs, sooner.<\/span><\/p>\n

We love meeting founders and innovators!<\/span><\/strong><\/p>\n

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

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ use_custom_gutter=”on” gutter_width=”2″ make_equal=”on” _builder_version=”4.19.4″ _module_preset=”default” width=”90%” max_width=”2560px” custom_padding=”16px|0px||||” locked=”off” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.18.0″ _module_preset=”default” custom_padding=”50px|20px|50px|20px|true|true” box_shadow_style=”preset1″ box_shadow_color=”rgba(71,71,71,0.18)” global_colors_info=”{}”][et_pb_blurb title=”ATMP Business Development, Quality Management, Continuous Improvement & Quality Risk Management (QRM)” use_icon=”on” font_icon=”||fa||900″ icon_color=”#962141″ image_icon_width=”50px” _builder_version=”4.18.0″ _module_preset=”default” header_font=”|700|||||||” header_text_align=”center” body_text_align=”center” body_font_size=”16px” global_colors_info=”{}”]<\/p>\n

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

We will develop your ATMP business and create the right culture from the initial concept and vision. <\/span><\/span><\/p>\n

W<\/span><\/span>e improve quality, productivity, brand, reputation, patient-centredness and customer satisfaction. <\/span><\/p>\n

We create asymmetric risk-reward ratios to stack the odds in your favour with larger margins of safety for patient protection. This is our highest value.<\/span><\/span><\/span><\/p>\n

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

We believe your customers should always come back but never your products!<\/span><\/span><\/span><\/span><\/p>\n

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

Greater quality &<\/span><\/span><\/span><\/span>\u00a0<\/span><\/span><\/span><\/span>productivity<\/span><\/span><\/span><\/span><\/p>\n

Greater brand & reputation<\/span><\/span><\/span><\/span><\/p>\n

Greater patient-centredness<\/span><\/span><\/span><\/span><\/p>\n

Greater customer satisfaction<\/span><\/span><\/span><\/span><\/p>\n

Greater project management<\/span><\/span><\/span><\/span><\/span><\/p>\n

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

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.18.0″ _module_preset=”default” custom_padding=”50px|20px|50px|20px|true|true” box_shadow_style=”preset1″ box_shadow_color=”rgba(71,71,71,0.18)” global_colors_info=”{}”][et_pb_blurb title=”ATMP Education & Talent Development” url=”https:\/\/www.ceutiqus.com\/bam\/courses\/” url_new_window=”on” use_icon=”on” font_icon=”||fa||900″ icon_color=”#962141″ image_icon_width=”50px” _builder_version=”4.19.4″ _module_preset=”default” header_font=”|700|||||||” header_text_align=”center” header_font_size=”18px” body_text_align=”center” body_font_size=”16px” global_colors_info=”{}”]<\/p>\n

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We support the development of your greatest assets; your people. <\/span><\/p>\n

We do this with world-class education and training provided by the:<\/span><\/p>\n

<\/span>BioPharmaceutiQals Academy Masterclass (BAM)<\/a><\/strong><\/p>\n

We also provide<\/a> succession planning training services e.g. trainee QP coaching and mentoring. <\/span><\/p>\n

We enable you to attract, recruit, train and retain the best using excellent training systems.<\/span><\/p>\n

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ATMP Expert QP designed & led<\/span><\/p>\n

Popular & p<\/span>roven system<\/span><\/p>\n

Regularly updated with the l<\/span>atest advances<\/span><\/p>\n

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

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.18.0″ _module_preset=”default” custom_padding=”50px|20px|50px|20px|true|true” box_shadow_style=”preset1″ box_shadow_color=”rgba(71,71,71,0.18)” global_colors_info=”{}”][et_pb_blurb title=”We design bespoke ATMP courses specific to your needs ” use_icon=”on” font_icon=”||fa||900″ icon_color=”#962141″ image_icon_width=”50px” _builder_version=”4.19.5″ _module_preset=”default” header_font=”|700|||||||” header_text_align=”center” header_font_size=”18px” header_line_height=”1.2em” body_text_align=”center” body_font_size=”16px” global_colors_info=”{}”]<\/p>\n

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

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

We have designed many courses tailored specifically to organisational needs and delivered them onsite for many organisations for many years. <\/span><\/p>\n

These courses give your staff the competitive advantage to successfully propel the organisation forward. <\/span><\/span><\/p>\n

They can also be co-designed with your input or we design them independently once we understand your unique and specific needs.<\/span><\/p>\n

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

Customised<\/span><\/p>\n

Convenient<\/span><\/span><\/p>\n

Improved efficiency & productivity<\/span><\/p>\n

Deeper understanding<\/span><\/span><\/p>\n

Greater technical expertise<\/span><\/span><\/p>\n

Greater engagement<\/span><\/p>\n

Greater staff retention<\/span><\/p>\n

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

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ use_custom_gutter=”on” gutter_width=”2″ make_equal=”on” _builder_version=”4.19.4″ _module_preset=”default” width=”90%” max_width=”2560px” custom_padding=”16px|0px||||” locked=”off” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.18.0″ _module_preset=”default” custom_padding=”50px|20px|50px|20px|true|true” box_shadow_style=”preset1″ box_shadow_color=”rgba(71,71,71,0.18)” global_colors_info=”{}”][et_pb_blurb title=”We are frequently invited to speak at ATMP corporations and conferences.” use_icon=”on” font_icon=”||fa||900″ icon_color=”#962141″ image_icon_width=”50px” _builder_version=”4.19.4″ _module_preset=”default” header_font=”|700|||||||” header_text_align=”center” header_font_size=”18px” header_line_height=”1.2em” body_text_align=”center” body_font_size=”16px” global_colors_info=”{}”]<\/p>\n

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We are frequently invited to speak at corporations and conferences on our expertise.<\/span><\/p>\n

We have also delivered onsite corporate training to multiple companies in the areas of:<\/span><\/span><\/p>\n

Making quality biological and advanced therapy medicinal products (ATMPs)<\/span><\/p>\n

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

Investigating Deviations Effectively and efficiently<\/span><\/p>\n

Quality by Design (QbD)<\/span><\/p>\n

Good Clinical practice (GCP)<\/span><\/p>\n

Good Manufacturing Practice (GMP)<\/span><\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.18.0″ _module_preset=”default” custom_padding=”50px|20px|50px|20px|true|true” box_shadow_style=”preset1″ box_shadow_color=”rgba(71,71,71,0.18)” global_colors_info=”{}”][et_pb_blurb title=”ATMP GMP Audits: Internal Self-Inspections and External Audits” use_icon=”on” font_icon=”||fa||900″ icon_color=”#962141″ image_icon_width=”50px” _builder_version=”4.19.5″ _module_preset=”default” header_font=”|700|||||||” header_text_align=”center” header_font_size=”18px” header_line_height=”1.2em” body_text_align=”center” body_font_size=”16px” global_colors_info=”{}”]<\/p>\n

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

We provide comprehensive GMP auditing services. These can be internal audits if we’re integrated into the team or external audits of your suppliers for excellent supply chain management.<\/span><\/span><\/p>\n

We commonly conduct QP-led GMP audits of critical suppliers to provide the greatest assurance from both a GMP expert and also a ATMP expert.<\/span><\/span><\/span><\/p>\n

We have proudly provided these services to not just make improvements but also build great partnerships within and outside the company.<\/span><\/p>\n

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

Supplier Management<\/span><\/span><\/span><\/p>\n

Materials Management<\/span><\/p>\n

QP Declarations<\/span><\/span><\/p>\n

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

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.18.0″ _module_preset=”default” custom_padding=”50px|20px|50px|20px|true|true” box_shadow_style=”preset1″ box_shadow_color=”rgba(71,71,71,0.18)” global_colors_info=”{}”][et_pb_blurb title=”Permanent ATMP Regulatory Authority Inspection Readiness Preparation & Remediation” use_icon=”on” font_icon=”||fa||900″ icon_color=”#962141″ image_icon_width=”50px” _builder_version=”4.19.4″ _module_preset=”default” header_font=”|700|||||||” header_text_align=”center” header_font_size=”18px” header_line_height=”1.2em” body_text_align=”center” body_font_size=”16px” custom_padding=”||0px|||” global_colors_info=”{}”]<\/p>\n

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We improve compliance, capability and confidence with the best advice on best practice to reduce inspection-anxiety and increase trust with regulatory authorities on a continuous basis for sustainable success.<\/span><\/span><\/p>\n

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

Gap Assessment &\u00a0Analysis<\/span><\/p>\n

SOP Development<\/span><\/p>\n

Inspection Readiness<\/span><\/p>\n

Mock Audits (UK, EU, US, ROW)<\/span><\/p>\n

Remediation and Implementation Plan<\/span><\/p>\n

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

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 <\/p>\n

Please get in touch for a free consultation to discuss your needs.<\/p>\n

 <\/p>\n

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