Services

AQS Bio has the expertise to evaluate biopharma assets, for the China market, as well as for prospect licensee biopharma companies. Process Steps:

• Work with client to develop initial business strategy, marketing materials, such as initial slide decks, etc.
• Determine the best possible industry segment paths for potential licensing partners.
• Contact select industry segment companies and introduce/position the biopharma asset.
• Commence the CDA process and execute the CDA’s with interested companies and continue discussions, visit and set up introductory meetings.
• Start and coordinate the due diligence process, with biopharma asset and interested companies.
• Begin the Non-Binding Term Sheet negotiation process with interested parties and narrow down the group of companies that are the best fit for biopharma licensor company.
• Final Term Sheet negotiations with select companies.
• Choose License partner based on Term Sheet, industry segment, company size and reach, best fit, etc.
• Negotiate License Agreement terms with select licensee company.

As companies implement or upgrade large-scale systems, the delivery of these projects need to be on time and within budget; thus the importance of experienced project management. Whether implementing a single departmental project or an enterprise-wide project with several project components, experienced project management is essential.

AQS Bio’s project managers have the systems and regulatory expertise to manage all phases of a project, including:

• Organization
• Planning
• Deployment
• Execution
• Monitoring
• Risk Management

AQS Bio’s quality audit services utilize expert audit teams that will extend your breadth and capabilities in conducting internal and external quality and compliance assessments, audits, and evaluations.

Our audit services leverage our expertise in regulatory requirements, quality systems, business processes in the drug and device life cycle, technology, applications, and a risk-based approach to compliance management. Audit recommendations take into consideration of industry best practices, current regulatory expectations, and risk.

Our expertise includes:

• Computer System Validation Assessment
• Gap Analysis and Regulatory Reviews
• System and Process Audits
• Vendor Audits
• Mock Inspections
• Periodic Reviews
• Quality Reviews

In the area of Quality Assurance, AQS Bio can assist your organization in the development of practical and effective quality management systems, including:

• Internal audit program reviews targeting critical process control points and GMP weaknesses
• GMP/GLP audit program design for compliance and manufacturing control
• Risk management assessments for QA/QC for effective resource utilization
• Establishment of comprehensive QA and manufacturing improvement programs
• Assessment of GLP programs.

AQS Bio offers complete life cycle validation services for computer systems. We have extensive experience with computerized systems used in manufacturing, quality assurance, document management, R&D, and clinical trials among others. We can validate systems for off-the-shelf software, configurable software or custom designed software.

AQS Bio’s computer system validation and 21 CFR Part 11 services formally incorporate a risk-based approach to compliance as an integral part of the System Life Cycle to ensure compliance with regulatory requirements. AQS Bio’s consultants have expertise in regulatory requirements, CSV methodologies, the technical aspects of computer system development, and the surrounding business processes. Our senior consultants are experts in managing and coaching developers, users, and validation teams to ensure successful conclusion of system implementation and validation efforts.

AQS Bio’s CSV services cover the full system life cycle, from requirements analysis through system retirement, including:

• Develop Validation Master Plans
• Prepare User Requirements, System Configuration, Specification, and Design Documents
• Prepare computer system validation policies, procedures and work instructions
• Provide templates for pre-qualification and qualification documentation
• Perform vendor audits
• Develop and execute test protocols (IQ/OQ/PQ)
• Develop Validation Summary Report
• Conduct IS / IT Gap Analysis studies

AQS Bio’s staff of compliance experts have developed a suite of training programs to help your company address regulatory compliance obligations effectively and efficiently. These comprehensive programs represent a best practices approach to regulatory compliance and can be tailored to suit a variety of audiences. Whether you require an awareness program for executives, an introductory program for managers and supervisors, or an advanced “how to” program for those responsible for performing the work, AQS Bio will present the appropriate level of information in the proper business context. We can also create customized training programs with your company-specific information – creating a program that is specific to your unique situation.

Standard Programs

• A Risk Based Approach to Computer System Validation
• 21 CFR Part 11
• cGMP/GLP Introductory and Departmentalized Courses