BioTechLogic - Biopharmaceutical and Technology Management Consulting

BioTechLogic is a biopharmaceutical and technology management and consulting firm that guides biopharma companies through all phases of the global biological pharmaceutical approval process. The company have proven capability to rapidly and successfully bring new biotech drugs to market through the augmentation and optimisation of a corporation’s technical resources.

Pharmaceutical approved process validation – the approach, the results, the conclusions.

BioTechLogic has expertise in managing all phases of process validation, and proven experience in presenting the approach, the results, and the conclusions of a successful validation to global regulatory agencies.

There are three important phases involved in process validation:

• Process pre-qualification
• Manufacturing qualification
• Life-cycle qualification

BioTechLogic can design the strategy to complete process validation in a timely and compliant manner, and effectively manage all activities related to these three phases.

BioTechLogic process validation services include:

• Pre-qualification report: establishment of critical process parameters and controls
• Process validation protocols and reports
• Life-cycle trending protocols

Regulatory submissions: development and preparation

BioTechLogic’s regulatory team supports global regulatory submissions, which have included recombinant proteins, antibody fragments, oligonucleotides, monoclonal antibodies and blood-based proteins. Our team has prepared briefing packages, module 2 (quality overall summary) and module 3 (chemistry, manufacturing, and controls) CTD regulatory submissions.

BioTechLogic regulatory submission services include:

• Developing the chemistry, manufacturing, and controls registration strategies for successful FDA, EMEA, and ROW submission and approval
• Preparing for agency meetings, including end of phase II meetings, BLA / NDA meetings, and facilities or process meetings
• Assisting with responses to questions from all global regulatory bodies

BioTechLogic has the staff to support the full preparation of module 2 (QOS) and module 3 (CMC) for global regulatory submissions. In addition, BioTechLogic will augment a client’s staff by performing the following tasks:

• Reviewing and evaluating manufacturing data
• Developing and reviewing CMC regulatory filings from Phase I INDs through license submissions
• Preparing BLA, NDA and MAA regulatory submission documentation in the CTD format for both drug substance / drug product and combination products

Pharmaceutical approved project management: cross-functional team leadership.

Founded on the principals prescribed by the project management institute (PMI), BioTechLogic’s work processes are tailored to meet the needs of the biopharmaceutical industry. Our highly skilled project managers possess project management protocol knowledge and have strong technical and business acumen. Their effective interpersonal and communication skills, and cross-functional team leadership experience allows them to work closely with your project leaders to plan, manage and execute the project.

BioTechLogic project management services include:

• Developing detailed plans and schedules
• Defining and documenting project team structures, roles and responsibilities
• Developing project communication plans and matrices
• Tracking and reporting progress to enable management at all levels to get a clear picture of project status, and upcoming activities and milestones
• Tracking and expediting the resolution of action items
• Highlighting critical project issues and risks, and mitigating action plans
• Planning, facilitating and conducting team meetings
• Managing the organization and storage of project documents
• Preparing periodic progress reports

Quality systems: assurance, compliance, audits and assessments

BioTechLogic provides 21st century global quality system consulting services to the pharmaceutical, biologics, and medical device industries. Quality for the 21st century is an initiative that needs practical and logical implementation.

Through the combined experience and knowledge of our staff, we have developed proven methodologies and approaches for providing reliable and dependable services in the following areas:

• The design and implementation of quality systems for pharmaceutical, biologic and medical device companies, with quality system upgrades to new standards and requirements
• The response of audits and assessments include responding to FDA 483 observations and addressing warning letters whilst preparing responses.
• Independent third-party GMP, QSR, ISO audits and gap assessments GMP / QSR / ISO quality system implementation and certified ISO auditor on staff.

Internal audits

The process for internal audits include, FDA / notified body inspection readiness training, mock PAI inspections and on-site audit support.