Innovative ECOSYSTEM FOR Biotech & CELL GENE THERAPY (CGT)

We offer traditional FDA Regulations based Quality and Compliance (QC) Services as below:

Our team of experts  have industry experience in setting QC strategy & framework, developing quality plan, policy and procedures based on FDA Regulations and Guidance in Biopharma, Cell Gene Therapy, Medical Devices companies.  

• Develop and Train on Quality Plan & Policy FDA CFR Part 210, 211, 820, ISO 9001, ICH
• Defining Quality Systems including Quality Management System (QMS), Learning Management (LMS) and Document Management System (DMS) , Audit, Quality Management Reviews (QMR) , Inspection Readiness,  Vendor Qualification and Quality Agreements with service level agreement (SLA)
• Define and setup common compliance controls framework using GenAI, this provides competitive advantage in knowing current compliance status with evidence at all times, ready for submissions and FDA inspections.  Covers vendors and CROs data to ensure confidence in data sources and use in internal systems.  GxP, HIPAA, SOC2, GDPR, SOX.

AI/ML and Data Science based QC Auto Pilot: coming soon to offer subscription fees based service that automates FDA Guidance and Annex based current updates, tied to company's (client) internal Policy and SOPs, to drive workflows with integration to internal GxP systems and equipment, that will perform many workflows that are done manually today.  This will change the industry wide life sciences ecosystem. 

• Perform Regulatory Submission work in IND, NDA for new start up clients, or existing companies to expand their therapeutics pipeline from Clinical Phase 3 to Commercial Launch.
• Perform Clinical Trial data management and systems setup and validation across EDC, IRT, CTMS, eCOA.  Perform complete UAT in selected systems (SaaS), in-house applications.  
• Perform Failure Mode Effect Analysis (FMEA),  ICH 9 QRM to document & manage risks
• Develop and deliver on CSV Life Cycle aligned with SDLC and/or Agile Process documentation in digital format.
• Execute on CSV and CQV protocols, document results and author summary reports
• Conduct CSV audits and Data Integrity Assessments, generate audit reports, issue CAPAs, work on Remediation effort to remedy audit observations for inspection readiness and product release
• Commission Facility, Utility, Equipment (FUE) and Labs Qualification Verification for selected systems.

• Define GxP IT Strategy and Program for Quality and Compliance Controls per FDA Regulations and Guidance, industry standards.
• Define installation and configurations of SaaS applications, per URS and FRS
• Configure systems to ensure Identity Access Management (IAM) and Cybersecurity  is robust and secured to avoid penetration attacks
• Perform change controls per documented and approved requests, make changes to configurations and workflows, test using CSV tools before release in production for users
• Conduct system maintenance and periodic reviews to maintain compliance and system health
• Timely backup and restore process to verify operations data is secured and available
• Disaster Recovery Plan and periodic testing to satisfy Business Contingency Plan (BCP)
• We provide under MSA, all IT services required by saving upfront costs, and increase funding for the actual R&D and scientific innovations.

• Drug Product and Aseptic Processing SME

• Small and Large-Scale mAb and Cell/Gene Therapy Facility Start-Up

• CMO and CDMO Selection and Manufacturing

• FDA Regulations / Regulatory Compliance (Part 211)

• Regulatory Preparation and Licensure

• DS and DP Clinical and GMP Manufacturing

• Technical Transfer

• Airflow Visualization SME

• Process Validation

• Operational Excellence

• Continuous Improvement

• Process Innovation

• Single Use Solution Design

• Facility Management

• Quality Systems

• CAPA (Corrective/Preventive Actions)

• Budget and Resource Forecast and Management

• Business Development

• Inventory Control processes

• Supply Chain and Logistics

• Procurement / Strategic Sourcing

We improve bioprocessing times and efficiencies by working with scientists and engineers. Set as-is vs. future models to demonstrates costs and time savings that results in reducing production time and gives a competitive edge to our customers in market place.

1. We can develop a ChatGPT-style interface trained on extensive, up-to-date bioprocess

knowledge. Expedite your process development activities with deeper queries on any CMC

topic, fully supported by literature references. Get the latest insights at your fingertips. This

could also be used to search your process specific data.

2. Novel data analysis of manufacturing data using neural network driven Bayesian Optimization

3. Automatically generate protocols, reports, and presentations to support Tech Transfer, Audits,

and CMC sections of Regulatory Submissions.

4. Process Development: Design of experiments, data analysis, presentation slides, supervision of

experiments either internally or at external CMOs

5. Tech transfer: Oversee tech transfer to either internal sites or CMOs, Design Scale up studies,

evaluate scale up risk using detailed process maps

6. GMP Production: Oversee GMP manufacturing either at internal sites or external CMOs, Draft

SOPs and other procedures, Deviation management, Root cause analysis, Risk assessments,

CAPAs and other quality documents

7. Raw Material: Sourcing of key RMs, setting internal specifications, oversee testing and release

of the RMs, Warehouse management, ERP implementation

8. Build Manufacturing Facility: Oversee conceptual designs, detail design and facility fit of

greenfield or brownfield projects. Equipment selection, procurement, installation and

qualification.

9. CMO management: Search and evaluate CMOs, Draft RFPs, compare bids, negotiate terms,

supervise the tech transfer of the process, oversee Engineering, clinical, PPQ and commercial

runs

10. Program and Project Management: Manage Program activities including product development

activities from early-stage lead generation, cell line development to clinical studies, and

commercial launch. Liasson with finance, marketing to ensure timely execution of activities

11. Validation: Design process characterization studies, write protocols, oversee execution of

studies, analyze data, define design space, write reports. Equipment IQ/OP/PQ

12. Continuous improvement: Lead Six sigma Kaizen events, Value mapping, Business process

improvements

13. IND and BLA write up: Draft and review CMC sections of IND, BLA and other regulatory

documents

14. Business Development: Draft business plans, represent the client in key conferences and

networking events, generate leads, coordinate meetings and negotiate term sheets

• State of the art virtual reality based platform to train and develop staffs in manufacturing operations that improves compliance and reduces deviations as a result of human errors.