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Your Partner in Biotech Success: Comprehensive CQV and Integrated Solutions
Empowering innovation and excellence in biotechnology and life sciences, we specialise in transforming complex challenges into strategic opportunities. With unparalleled expertise in CQV, project management, laboratory design, and regulatory compliance, our tailored solutions drive impactful results and foster sustainable growth for organisations at the forefront of scientific advancements.
Comprehensive Biotech Services for CQV and Beyond:
At BioServices, we are committed to advancing biotechnology by providing end-to-end solutions tailored to meet the evolving needs of the industry. From Commissioning, Qualification, and Validation (CQV) to regulatory compliance, laboratory design, and project management, we empower organizations to achieve excellence in both scientific and commercial endeavors. With unparalleled expertise and a dedication to innovation, we support cutting-edge research, streamline operations, and drive impactful progress to deliver measurable results for our clients worldwide.
Empowering Biotechnology for Breakthrough Results
Explore our diverse range of biotech services, built on innovation and excellence to meet your needs.
End-to-End CQV and GMP Solutions: Your Partner in Commissioning, Qualification, Validation, and Operational Excellence
Laboratory Design & Setup: Creation of cutting-edge facilities, procurement of equipment, and integration of workflows for operational excellence.
Regulatory Compliance & Quality Assurance: Expertise in SOP development, audits, risk assessments, and regulatory documentation to maintain GMP and QC standards.
Clinical Trials & Product Development: Guidance on drug development, ATMP production, and bioprocessing for advanced therapies.
Business Development: Market research, strategic planning, and client engagement to foster long-term partnerships and growth.
Training & Knowledge Management: Development of training programmes, technical documentation, and operational resources to support efficiency and compliance.
Process Optimization: Implementation of cost-saving strategies, operational improvement, and automation solutions.
Sustainability Strategies: Integration of eco-friendly practices in facility operations and process development.
Technical Audits & Due Diligence: Comprehensive reviews to ensure compliance, quality, and operational readiness.
Risk Management: Identification, assessment, and mitigation strategies to manage project challenges effectively.
Research Support
Designed to enhance your research with precision and expertise.
Development Solutions
Tailored strategies to streamline your developmental processes.
Innovation Consulting
Focused on delivering exceptional insights and dependable results.
Accelerating Biotech Advancements with Tailored Expertise
Explore the comprehensive range of services we offer to empower groundbreaking research and accelerate progress in biotechnology and life sciences. Our expertise in Commissioning, Qualification, and Validation (CQV) ensures operational excellence and regulatory compliance for GMP utilities, systems, and facilities. From drafting and implementing Validation Master Plans (VMP), Standard Operating Procedures (SOPs), and User Requirements Specifications (URS) to executing protocols such as IQ, OQ, and PQ, we deliver tailored solutions for seamless commissioning and startup.
In addition to CQV, we excel in laboratory design, project management, bioprocessing for advanced therapies, and Health & Safety (H&S) compliance. Our expertise also extends to facility and equipment relocations, where we provide comprehensive support to ensure smooth transitions with minimal disruption to operations. This includes planning, coordinating logistics, revalidation, and ensuring compliance in the new setup.
Our proficiency in conducting FAT/SAT testing, performing audits, risk assessments, and navigating complex regulatory landscapes ensures your project is handled with precision and care. Whether developing ATMPs, integrating H&S best practices, or streamlining operational processes, our team of experts is committed to driving innovation and creating impactful results. Partner with us to transform challenges into opportunities and achieve excellence in every facet of your biotechnology journey.
Advanced Diagnostics
Enhancing precision and accuracy for cutting-edge scientific analysis.
Custom Biotech Services
Tailored solutions designed for unique research and development needs.
Sustainable Processes
Promoting eco-friendly advancements in biotechnology applications.
Collaborative Research
Fostering partnerships to achieve groundbreaking scientific discoveries.
Innovative Services for Your Biotech Challenges
Our Services
Whether you are navigating complex regulatory landscapes, setting up cutting-edge labs, or optimizing your operations, our expertise ensures success. Our core offerings include:
Project & Programme Management: Efficiently managing resources, risk, and timelines while driving success through effective planning and prioritization.
Laboratory Design & Setup: Creating state-of-the-art facilities, managing equipment procurement, and ensuring compliance with regulatory standards.
Regulatory Compliance & Quality Assurance: Assisting clients in achieving GMP and QC compliance with services such as SOP development, audits, and risk assessments.
Clinical Trials & Product Development: Providing guidance on R&D, drug development, ATMP production, and bioprocessing for advanced therapies.
Business Development: Supporting client engagement, market research, and establishing sustainable partnerships to foster long-term growth.
Training & Knowledge Management: Developing tailored training programmes, user documentation, and operational frameworks for enhanced efficiency.
Highlighted Service: CQV (Commissioning, Qualification, Validation) We specialise in commissioning, qualification, and validation (CQV) services to ensure your GMP utilities, systems, and processes meet stringent regulatory standards. Our comprehensive CQV solutions include:
Ensuring seamless Commissioning, Startup, and ongoing process validation.
Development of Validation Master Plans (VMP).
Integrated Commissioning and Qualification (ICQ) and execution of Pre-Operational Verifications.
Drafting and implementation of User Requirements Specifications (URS), Standard Operating Procedures (SOPs), and Risk Assessments.
Execution of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Conducting Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
Current Good Manufacturing Practice (cGMP) and Good Automated Manufacturing Practice (GAMP) reviews.
Delivery of Summary Reports, Technical Audits, and Due Diligence.
We also assist and deliver to organizations of any size strategic, IT and business consulting and advisory services with a strong emphasis on internal controls implementation, auditing readiness, policy development and process optimization. Our goal is to help businesses operate more efficiently, stay compliant, and unlock sustainable growth.
With over a decade of experience across diverse industries, our consulting services are built on deep expertise in:
- IT Governance & Cybersecurity Compliance (NIST, SOX, ISO 27001, TISAX, UK Cyber Essentials, GDPR, SOC)
- IT Auditing Readiness & Risk Management
- Cloud Security, Data Protection, Cyber Risk Mitigation, IT Data Engineering among others
- Business Process and IT Auditing and Optimization
- Policy, Procedure, and Controls Design & Implementation
We go beyond strategic advice by working directly with clients to:
- Develop and implement robust company policies tailored to business, regulations and operational needs
- Improve and standardize existing business processes to eliminate inefficiencies and reduce operational waste
- Align policies and procedures with industry best practices to support compliance and long-term performance
- Introduce automation and data-driven tools to enhance audit readiness, security posture and decision-making
- IT Consulting & Digital Transformation by integrating AI into business processes
**Our penetration testing services will be launching in due course. Stay tuned for expert security assessments to help safeguard your systems.**