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Submission: On October 14 via manual from US — Scanned from DE
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* Regulatory Sciences Expertise at every stage. DevelopmentClinicalCommercial Some of the specialized fields we support: Medical Device and DiagnosticCell and Gene Therapy OVERVIEW FDA SERVICES: DRUG DEVELOPMENT Regulatory Strategy/Gap AnalysisFDA Meeting Strategy and ExecutionFDA SubmissionsNonclinical Drug DevelopmentChemistry, Manufacturing, and Controls (CMC) Advice and ManagementClinical Pharmacokinetics (PK)/Pharmacodynamics (PD)Regulatory Due DiligencePre-Approval AuditsSpecialized Regulatory Consulting Services EMA/NATIONAL AGENCIES SERVICES: PRE-AUTHORIZATION Regulatory Strategy/Gap AnalysisRegulatory DeliverablesClinical Trial Applications (CTAs)Medical/Technical WritingScientific AdviceChemistry, Manufacturing, and Controls (CMC) Advice and ManagementPeri-Approval Services EMA/NATIONAL AGENCIES SERVICES: POST-AUTHORIZATION Product Lifecycle ManagementProduct LaunchRegulatory Project ManagementRegulatory Intelligence (RI)Promotional Material US & EU: MEDICAL DEVICE DEVELOPMENT FDA Medical Device Development and Regulation Consulting ServicesEU Medical Device Development EMA/NATIONAL AGENCIES SERVICES: REGULATORY OPERATIONS Regulatory Operations SPECIALIZED SERVICES Cell and Gene TherapyMedical Device and DiagnosticBrexit * Life Science Consulting Expertise at every stage. DevelopmentClinicalCommercial Some of the specialized fields we support: Medical Device and DiagnosticCell and Gene Therapy OVERVIEW COMPLIANCE Quality Management Systems (QMS)RemediationFDA Form 483 Inspectional Observations and Warning LettersQuality Assurance (QA)Qualified Person (QP) ServicesResponsible Person (RP) ServicesManufacturing and Import License (MIA) and European Market AccessPre-Approval Inspection and GxP AuditsQuality InvestigationsCompliance with the Falsified Medicines Directive PRODUCT AND PROCESS LIFECYCLE MANAGEMENT Technology TransferProcess OptimizationProgram and Project ManagementProcess and Product Development ManagementVendor Selection & Management Services COMMISSIONING, QUALIFICATION, AND VALIDATION Process ValidationCleaning and Sterilization ValidationGood Manufacturing Practices (GMP) Product Lifecycle MethodsData Integrity ServicesComputer System ValidationEquipment, Utilities, and Facilities CLINICAL CONSULTING Medical Monitoring ServicesData Safety Monitoring BoardSafety Management Plan (SMP) Development SPECIALIZED SERVICES Cell and Gene TherapyMedical Device and DiagnosticBrexit * R&D Technology Expertise at every stage. DevelopmentClinicalCommercial Some of the specialized fields we support: Medical Device and DiagnosticCell and Gene Therapy OVERVIEW R&D TECHNOLOGY SERVICES Research Systems Technology SolutionsClinical Systems Technology SolutionsLaboratory and Manufacturing Technology SolutionsCommercial Technology ServicesComputer System Validation * Clinical Research Solutions Expertise at every stage. DevelopmentClinicalCommercial Some of the specialized fields we support: Medical Device and DiagnosticCell and Gene Therapy OVERVIEW CLINICAL RESEARCH CAPABILITIES Clinical OperationsMedical Monitoring ServicesData Safety Monitoring Board (DSMB)Biostatistics and ProgrammingClinical Data Management ServicesMedical Writing ServicesPeri and Post Approval Services (PPAS) THERAPEUTIC AREAS / SPECIALTIES CardiovascularCell and Gene TherapyCentral Nervous System (CNS)Infectious Diseases and VaccinesMedical Device and DiagnosticsOncology / HematologyOphthalmologyPediatricsRare / Orphan DiseaseRespiratory WORK WITH US Full Service CROFunctional Service Provision (FSP)Decentralized Clinical Trials (DCTs) * Pharmacovigilance Expertise at every stage. DevelopmentClinicalCommercial Some of the specialized fields we support: Medical Device and DiagnosticCell and Gene Therapy OVERVIEW CLINICAL PV Safety Management Plan (SMP) DevelopmentClinical Pharmacovigilance (PV) Auditing ServicesIndividual Case Safety Reports (ICSR) Processing and ReportingAggregate Safety Report Generation and ReportingData Safety Monitoring BoardMedical Monitoring POSTMARKETING PV Qualified Person for Pharmacovigilance (QPPV) and Local Person for Pharmacovigilance (LPPV) ServicesIndividual Case Safety Reports (ICSR) Processing and SubmissionAggregate Safety Report Generation and ReportingGlobal and Local Literature ScreeningSignal ManagementPharmacovigilance System Master File (PSMF) Development and MaintenanceRisk Management Plan (RMP) Development and MaintenancePostmarketing Pharmacovigilance (PV) Auditing ServicesNamed-Patient and Compassionate Use Programs * Medical Information Expertise at every stage. DevelopmentClinicalCommercial Some of the specialized fields we support: Medical Device and DiagnosticCell and Gene Therapy OVERVIEW GLOBAL MEDICAL INFORMATION CONTACT CENTERS Global 24/7/365 Contact Center SupportAdverse Event (AE) Intake and Follow-up ServicesProduct Complaint Intake and Follow-up ServicesAfter Hour Services MEDICAL WRITING AND CONTENT MANAGEMENT Standard Document CreationCustom Response and Content ManagementResponse Document MaintenanceTranslation and Localization Services OTHER MI SERVICES Patient Support ProgramsPromotional ReviewCongress/Booth SupportClinical Trial Emergency Unblinding Services * Product Lifecycle Stages Development Clinical Commercial * Specialized fields Medical Device and Diagnostic Cell and Gene Therapy * About Us * Blog * Events * Resources * * * * Deutsch * 日本語 * Careers * Request Services Home / Life Science Consulting< See Life Science Consulting / Cell and Gene Therapy CELL AND GENE THERAPY CELL AND GENE THERAPY – CENTER OF EXCELLENCE Cell and Gene Therapy (CGT), also known as Advanced Therapy Medicinal Products or ATMPs, holds the promise to deliver transformative outcomes in a wide array of hard-to-treat diseases. Our Cell and Gene Therapy Center of Excellence helps clients around the world accelerate their novel, advanced therapeutic products to market. ProPharma Group’s team of cell and gene therapy consultants has supported more than 100 different CGT development programs. These programs contain a diverse set of CGT/ATMP technologies, including various viruses and vector types, oncolytic viruses, and an increasing number of gene modified cell therapy modalities. Our cell and gene therapy consulting team has a combined 25 years of experience delivering unique lifesaving treatments to market in both EU, US, and Japanese regulatory environments. We have a diverse talent pool comprised of technical, scientific, quality assurance (QA), and regulatory sciences/regulatory affairs professionals to support you across the full development lifecycle to effectively and efficiently bring products to patients. We accomplish this by assisting our cell and gene therapy clients through early-stage and nonclinical product development, clinical trials, marketing authorization and all associated regulatory aspects, and GMP manufacturing. At ProPharma Group, our approach is to begin with the end in mind. We identify potential challenges and help craft strategies and solutions before you are confronted with them during a regulatory assessment. CELL AND GENE THERAPY SERVICES There are many regulatory, technical, and scientific challenges that can significantly impact the successful outcomes in the product development and commercialization of cell and gene therapies. Our Center of Excellence services, specific to cell and gene therapy, include but are not limited to: * Regulatory strategies and gap analysis development plans, to include a forecast of key milestones, necessary documentation, overall effort, cost, and plan of action * Formal Meetings with regulatory agencies, including formal meetings with FDA, EMA, and national competent authorities (NCAs) * Expedited approvals with FDA and EMA, including PRIME applications, orphan designation applications, Emergency Use Authorizations (EUAs), Priority Review, Fast Track, Breakthrough Therapy, and Accelerated Approval designations * Consulting on appropriate development strategies (eg, biodistribution, tumorigenicity, and orphan designations) * Clinical Trial Application (CTA) and Investigational New Drug (IND) support, working with you to develop and submit a complete and successful application including genetically modified organism (GMO) applications in the EU * SME Status Application, including guidance filling out and submitting the electronic declaration form with other necessary information such as proof of establishment, a chart of ownership structure, and recent data for the applicant enterprise * Pediatric Investigation Plans (PIP) that meet the needs of both the FDA and EMA, allowing your product to advance to the next regulatory milestone * Clinical trial support, including assistance designing and executing your clinical trials to achieve successful outcomes * EU Marketing Authorization Application (MAA) and FDA Biologics License Application (BLA) support, including development and submission of the application to the regulators * Good Manufacturing Practice (GMP) compliance assistance, including the design of GMP manufacturing facilities, including commission, qualification, and validation * Quality Management System (QMS) design, including the development and implementation of effective and customized QMS programs or the optimization of existing programs * Technical Transfer(s), including guidance for creating a comprehensive plan to manage the transfer of products and processes between sites * Classification advice – is your product a CGT/ATMP, a medical device, or a combination product? * Consultation on comparability studies for your product before and after changes are made to the manufacturing process * Regulatory submission and deliverable support, including data summary and document writing (eg, IMPD, IB) * FDA and EMA classification and certification procedures for CGTs/ATMPs * Regulatory aspects of grant applications * Clinical investigations for biomaterials including preclinical testing * Risk assessment and remediation of data packages, existing processes and systems, etc. * Process Optimization, using a tailored approach to streamline manufacturing procedures and overcome challenges that threaten the continuity of your commercial supply * Vendor selection and auditing to ensure compliance with quality and regulatory requirements While the science, quality demands, regulations, and clinical use of cell and gene therapy evolves, companies need a partner that can define appropriate development strategies to manage the ever-changing regulatory environment and anticipate what will be required in years to come. ProPharma Group is that partner. Our vast breadth of service offerings paired with our diverse panel of cell and gene therapy/ATMP specialists is unlike anything you have ever experienced. With a full suite of global services that spans the entire product lifecycle, our team of cell and gene therapy consultants is comprised of the best regulatory and compliance consultants across the globe. No matter what stage you’re in, you need to ensure your product remains compliant with applicable regulations and requirements, commensurate to the stage of development. Our cell and gene therapy consultants have the expertise to help you obtain successful interactions with regulators. CONTACT OUR CELL AND GENE THERAPY CONSULTING EXPERTS Our name truly does say it all: Cell and Gene Therapy – Center of Excellence. Delivering excellent work is not just our goal, it is all we will accept. But rather than tell you about it, here are some case studies that prove it. US TO EU TRANSITION (CELL THERAPY): * Company in clinical development in the US and planning to open trial sites in the EU * Regulatory gap analysis and development plan provided to define the EU regulatory strategy * EU scientific advice taken * Successful orphan application * IMPD written, liaising with EU manufacturer to provide the detail expected by national agencies in the EU * Regulatory support provided throughout the CTA FULL EU REGULATORY PROVISION (GENE THERAPY): * Company in clinical development in US * Regulatory gap analysis and development plan provided to define the EU regulatory strategy, support in scientific advice, and Orphan and PRIME submissions * Carried out the role of EU regulatory support to Sponsor, providing full CTA management services for over 20 CTA submissions and GMO application support * MAA leadership through to approval A GLOBAL TEAM BRINGING BROAD AND DEEP EXPERTISE IN CELL AND GENE THERAPY Our Cell and Gene Therapy – Center of Excellence nurtures a think tank of cell and gene therapy consultants. We provide a comprehensive suite of integrated cell and gene therapy services and solutions to advance your product to the next milestone while maintaining the highest compliance standards. Our team’s expertise supports you throughout the full lifecycle of cell and gene therapy product development, from early-stage concept development through post-commercialization. To learn more about our full suite of cell and gene therapy consulting services and how we can help you accomplish your goals, contact us today. Contact Us RELATED SERVICES * Cannabis and CBD * Data Integrity FIND OUT HOW WE CAN HELP YOU Our experts are ready to tackle your challenge. Request a Call PRODUCT LIFECYCLE Expertise at every stage. * Development * Clinical * Commercial HELPFUL LINKS * Contact Us * Blog * Events * Resources Interested in gaining an industry edge? Let us help you stay current. Sign up for email. Get Industry Insights -------------------------------------------------------------------------------- BLOG / October 12, 2022 Prescription Drug User Fee Act (PDUFA) VII and Type D… BLOG / September 27, 2022 What You Need to Know About CBER Pre-IND Meetings EVENTS 1. 2. 3. OCTOBER 19-20 Veeva R&D and Quality Summit OCTOBER 24-26 BIO-Europe OCTOBER 25-27 Gene Therapy for Rare Disorders… view all events Sign up for updates and industry insights -------------------------------------------------------------------------------- LOOKING TO MAINTAIN QUALITY AND COMPLIANCE FOR YOUR PRODUCT? Contact us to learn how our team of specialists can ensure quality and regulatory requirements are met throughout your product’s lifecycle to successfully bring your product to market. Interested in gaining an industry edge? Let us help you stay current. Sign up for updates and industry insights -------------------------------------------------------------------------------- All fields are required. There was a problem with your submission. Errors have been highlighted below. Contact us to learn how we can help -------------------------------------------------------------------------------- GAIN AN INDUSTRY EDGE WITH EXPERTISE FROM PROPHARMA GROUP Get the latest insights and top tips from our experts, delivered right to your inbox. Have a complex challenge? Contact us to learn how we can help -------------------------------------------------------------------------------- All fields are required. There was a problem with your submission. Errors have been highlighted below. LIFECYCLE STAGE * Development * Clinical * Commercial CORE SERVICES * Regulatory Sciences * Life Science Consulting * R&D Technology * Clinical Research Solutions * Pharmacovigilance * Medical Information PROPHARMA GROUP * About Us * Diversity, Equity, and Inclusion * Events * News & Blog * Resources * Press Center * Contact Us Careers Request Services * * Language: Deutsch | 日本語 Copyright © 2022. 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