R&D Compliance and Quality made simple
Compliance: Fit for Purpose
I come with the belief that everyone wants to do a good job, motives are pure and intentions are well meaning. Sometimes execution or results do not align with expectations. That is OK.
I haven’t found anyone, who is perfect (this includes me). It’s the actions taken to bring the deficiency into alignment that is important, i.e. achieving for the intended purpose.
Simple, sustainable, scale-able = Fit for Purpose
Compliance & Quality Services
Risk Assessment
You don’t know what you don’t know.
Risks present themselves in different ways. They are not limited to the non-conformances identified in audits or inspections. While these non-conformances are a type of risk, they do not constitute all possible risks. Left neglected, many risks lead to non-conformances.
DiMarco Consulting can help mitigate those risks. We can help maintain or, if necessary, improve compliance. Our systematic approach identifies risks and we can help mitigate negative outcomes.
When activity is useful: Organizational re-design, change in leadership, mergers/acquisitions.
The business of science.
Due diligence is focused on the interactions between your company and another entity and the impact on the asset. It is an evaluation of the implications for your company/asset and helps to determine the favorability of the business activity, e.g. co-marketing, co-development.
At DiMarco Consulting, we understand how business decisions impact regulatory compliance and how regulatory compliance supports the business.
When activity is useful: Mergers/acquisitions/divestment, new business partner/co-marketer/ distributor, co-development/investigator-initiated research, vendor selection
Due Diligence
Due Diligence
The business of science.
Due diligence is focused on the interactions between your company and another entity and the impact on the asset. It is an evaluation of the implications for your company/asset and helps to determine the favorability of the business activity, e.g. co-marketing, co-development.
At DiMarco Consulting, we understand how business decisions impact regulatory compliance and how regulatory compliance supports the business.
When activity is useful: Mergers/acquisitions/divestment, new business partner/co-marketer/ distributor, co-development/investigator-initiated research, vendor selection
Inspection Readiness Programs
Practice Success.
The success factors with any inspection are effectively communicating what was done and being able to demonstrate it. Sounds simple…yet it can be difficult to do especially in the high-stress scenario of a health authority inspection.
Being prepared significantly increases chances of success and these programs help ensure institutional knowledge is captured, strategy is set and the pertinent individuals to represent the company/topics are identified. With work being highly outsourced and/or conducted across the global, establishing the expectations of those not on site during the inspection is also critical.
When activity is useful: awaiting product approval, mergers and acquisitions, once established…routinely
Plan, Do, Check, Act: GCPs and GVPs.
Applying Quality concepts to R&D activities can be challenging, particularly as the Quality requirements within the R&D space have grown well beyond the conduct of audits.
Process improvement activities, e.g. Kaizen, are necessary to ensure processes are robust and support the organization’s growth. Trend analysis of audit findings identifies risks. Key performance Indicators and Key Quality Indicators (KQIs) are used to track the health of the organization.
DiMarco Consulting can help in translating and applying the concepts to the work at hand.
When activity is useful: assessing compliance with GCPs or GVPs, inspection readiness
Quality Services
Quality Services
Plan, Do, Check, Act: GCPs and GVPs.
Applying Quality concepts to R&D activities can be challenging, particularly as the Quality requirements within the R&D space have grown well beyond the conduct of audits.
Process improvement activities, e.g. Kaizen, are necessary to ensure processes are robust and support the organization’s growth. Trend analysis of audit findings identifies risks. Key performance Indicators and Key Quality Indicators (KQIs) are used to track the health of the organization.
DiMarco Consulting can help in translating and applying the concepts to the work at hand.
When activity is useful: assessing compliance with GCPs or GVPs, inspection readiness
What service is right for you?
These topics are often intertwined, e.g. an audit is part of due diligence in selecting a vendor, a risk assessment is completed as part of inspection readiness program. At times, the biggest challenge is having the leadership and personnel in place to execute as individuals move to other organizations.
When this occurs, DiMarco Consulting provides supplemental or interim leadership for Quality and Compliance organizations while the company searches for a leader full time. DiMarco Consulting can work with you to determine what is needed to meet your goals. We provide the services fit for YOUR purpose.
About DiMarco Consulting
At DiMarco Consulting, I want to help you find a way to be compliant that is simple and sustainable. The Quality Management System (QMS) is typically designed and managed by the manufacturing organization. Manufacturing and R&D are different. It isn’t always clear as to how the requirements are applied or impact the science being done.
Once the requirements are clear, there are many different ways to achieve and demonstrate compliance. It is never “One size fits all”. The DiMarco Consulting philosophy is that solutions need to be Simple, Sustainable and Scale-able. The solutions or processes put in place, must be FIT FOR PURPOSE. If not, those doing the work may not be able to execute.