We get the job done right,
the first time.
Client Goals are our Focus
We implement best practices to quickly identify our client's most important priorities.
With a strong focus on the client’s business goals, we use our expertise in licensure, risk management, and data integrity to meet our client’s long-term objectives.
Bringing a drug to the market is not a simple process. BioQPartners implements a wide array of biopharmaceutical practices to quickly help identify your most important priorities.
Our comprehensive support ensures approval of your BLA in accordance with regulatory compliance guidelines.
Successful navigation of the path from basic science to NDA approval, and then commercialization, requires experience and expertise. Ultimately, this is a challenge of technical creativity, planning, leadership, and especially for Quality, effective management of a variety of risks.
We have the expertise and experience to help you identify your risks, to determine your true, goal-oriented priorities, and to help you manage and address those factors, thereby helping to ensure successful approval of your BLA.
Quality Assurance
LEADERSHIP CONSULTING
Probably the most important attribute of effective Quality Assurance is the capability to identify, manage, mitigate and appropriately accept risk. It is therefore important to understand your own sensitivity and tolerances to risk, and to have a plan for dealing with the worst-case scenario. By understanding the basic first principles, you can develop the most effective solution for any situation.
Here are some specific services that I can offer as a quality assurance leadership consultant:
Quality Systems Approach: I can help you with the design and implementation of your Quality System, in a way that is phase-appropriate and based on the need to manage risks at each stage of development. I believe that Quality Systems, and the procedures they are built from, should be only as prescriptive and sophisticated as necessary to meet the needs for control. This means I’ll help you balance procedural controls with staff education, training and upskilling.
Risk assessment: I can help you identify and assess the risks associated with your project. This can involve a variety of tasks, such as identifying potential hazards, evaluating the likelihood of occurrence, and assessing the impact of each hazard.
Root cause analysis: I can help you identify the root causes of problems that occur during your project. This can involve a variety of tasks, such as collecting data, interviewing stakeholders, and developing hypotheses.
Corrective action planning: I can help you develop and implement corrective action plans to address the root causes of problems. This can involve a variety of tasks, such as developing specific actions, assigning responsibility, and tracking progress.
Training: I can provide training on quality assurance principles and practices to your team. This can help to ensure that your team is aware of the risks associated with your project and how to mitigate those risks.
I can also help you to develop a quality assurance plan for your project. This plan should outline the specific activities that you will undertake to ensure the quality of your project. The plan should be tailored to the specific risks and challenges of your project.
I am confident that I can help you to ensure the quality of your project. I have a wealth of experience in quality assurance and leadership consulting, and I am passionate about helping clients to achieve their goals. I would be happy to discuss your specific needs in more detail and to provide you with a proposal.
Quality Systems
DESIGN IMPLEMENTATION
Risk is intrinsic to plans and action. A failure to proactively manage risk will greatly increase the likelihood of a major disruption to those plans. With a program as complex as development of a novel biotech product, it is therefore essential to have a robust risk management plan in place. This would entail:
Risk identification and Inventory: Identify and record all major sources of business risk, from non-compliance, through workforce competition, all the way to natural disasters.
Risk characterization and quantitation: Determine the estimated likelihood, impact and detectability of each risk, reduced to financial and reputational costs, allowing comparison of disparate risks.
Risk Ranking and Prioritization: Sorting by factors based on characterization, typically using an “expected value” model.
Risk Mitigation Planning: Identify plans and actions to reduce unacceptably high risks. Manage actions to completion.
Risk Acceptance: The other alternative to mitigation – this structure process allows an organization to align on what level of risk is acceptable and to carry that risk in an informed manner going forward.
We can help you develop and implement comprehensive risk management programs for your company, that span not just quality and compliance, but a more holistic view, allowing a more complete allocation of available resources.
All‑encompassing Strategies
PLANNING AND EXECUTION
Strategic planning is essential for any organization, but it is especially important for biotech companies. The biotech industry is highly competitive, has very complex technology and is highly regulated. Therefore, companies need to have a clear plan in order to succeed. Strategic planning and the integration of effective risk management practices are particularly important for smaller companies seeking to attract investment capital, or companies seeking to be acquired.
Here are some of the benefits of having a strategic plan for a biotech company:
Increased focus: A strategic plan can help biotech companies to focus on their core competencies and to avoid distractions.
Measurement of Success and definition of Goals: Business goals exist in support of strategy execution. Measuring success by fitness for this purpose helps avoid extra work and mis-aligned effort.
Clarity and Alignment for NDA content and submissions to major health authorities: While health authorities each have their own specific requirements, there is huge overlap in expectations. Additionally, major HA’s communicate regularly and are know to share notes on submissions for the same product in different geographies. Getting ahead of this complexity will aid in NDA preparation and approval.
Improved decision-making: A strategic plan can provide biotech companies with a framework for making decisions. This can help to ensure that decisions are made in a timely and informed manner.
Increased efficiency: A strategic plan can help biotech companies to be more efficient by streamlining processes and eliminating waste.
Improved communication: A strategic plan can help biotech companies to communicate their goals and objectives to their employees and stakeholders. This can help to ensure that everyone is on the same page and working towards the same goals.
Increased collaboration: A strategic plan can help biotech companies to collaborate with other organizations, such as universities and research institutions. This can help to accelerate the development of new drugs and therapies.
Technical Guidance
REGULATORY COMPLIANCE
In the Biotech field, the degree to which you have solid systems and processes in place will determine your project’s level of success or failure. We have the unique ability to understand how Quality Systems work and to utilize those systems to ensure you operate in a safe and compliant manner. Whether you’re building a new building, a process, or a novel therapeutic, Quality Systems are integral to giving your project the greatest chance of success. Infrastructural development, as it relates to quality, is a hallmark of any biotech manufacturing facility. We build systems that are not only sustainable but perform as they should in the long run.
Accuracy Assurance
DATA INTEGRITY
FDA and other Health Authorities have clear expectations for data integrity. Data integrity is about the accuracy and reliability of data and confers fitness for purpose. It’s important to think about data integrity when we first start to generate data that may be used to support an NDA. Many companies address this point too late in the development cycle, thereby jeopardizing the approval of the submission. By having a robust data integrity program in place, you can minimize the risk of errors and ensure that your company is compliant with regulations.
Enterprise Perspective
RISK MANAGEMENT
Risk is intrinsic to plans and action. A failure to proactively manage risk will greatly increase the likelihood of a major disruption to those plans. With a program as complex as development of a novel biotech product, it is therefore essential to have a robust risk management plan in place. This would entail:
Risk identification and Inventory: Identify and record all major sources of business risk, from non-compliance, through workforce competition, all the way to natural disasters.
Risk characterization and quantitation: Determine the estimated likelihood, impact and detectability of each risk, reduced to financial and reputational costs, allowing comparison of disparate risks.
Risk Ranking and Prioritization: Sorting by factors based on characterization, typically using an “expected value” model.
Risk Mitigation Planning: Identify plans and actions to reduce unacceptably high risks. Manage actions to completion.
Risk Acceptance: The other alternative to mitigation – this structure process allows an organization to align on what level of risk is acceptable and to carry that risk in an informed manner going forward.
We can help you develop and implement comprehensive risk management programs for your company, that span not just quality and compliance, but a more holistic view, allowing a more complete allocation of available resources.
Launching New Modalities
NOVEL THERAPEUTICS
The regulatory landscape for novel therapeutics such as cell therapy and gene therapy is developing rapidly. At the same time, product development is progressing at an even faster pace, resulting in the need for companies to future-proof their early work against later standards at the time of NDA submission and approval. We use a combination of real-world experience and first principles thinking to establish the right controls and then plan the right studies, with the aim of filling all the needs of the NDA.