R&D Compliance and Quality made simple
Compliance: Fit for Purpose
DiMarco Consulting is a boutique consultancy helping scientists and health care professionals operating within the Pharmaceutical and Biotechnology regulatory environment understand how the regulations apply to their work, simply and effectively.
All companies need to follow the same set of regulations; however, each company has a different culture and organizational structure. There are many different ways to achieve compliance and quality. I love what I do and enjoy creating unique solutions because it is never “One size fits all”. Ultimately, it must be fit for YOUR purpose.
SIMPLE, SUSTAINABLE, SCALE-ABLE = FIT FOR PURPOSE
Approachable Compliance is about being open minded and flexible while still operating within the regulatory requirements.
A robust compliance program can help with:
- Getting to approval faster by helping to address the regulatory pitfalls that delay approval. (Risk Assessments)
- Ensuring health authority compliance through mergers and organizational change. (Due Diligence)
- Being inspection ready at all times. (Inspection Readiness)
- Developing a quality management system that is simple and sustainable. (Quality Services)
Because every organization is different, the solutions need to be customized, i.e. Fit for Purpose.
Compliance & Quality Services
Risks present themselves in different ways and not all risks are non-compliances. The biggest risk will always be:
“You don’t know what
you don’t know”.
This can be an internal gap analysis/compliance assessment or part of an acquisition or merger.
Inspection Readiness Programs
Determining who on the team is best positioned to represent a topic and capturing institutional knowledge are critical success factors for an inspection.
Audits, Root Cause Analysis, Corrective Actions and Preventative Actions (CAPA), Effectiveness Checks for GCP and PV System/GVP.
Lean Six Sigma: Black belt certified.
About DiMarco Consulting
DiMarco Consulting is a boutique consultancy passionate about providing compliance and quality consulting services for R&D teams in Pharmaand Biotech, specializing in simple, effective solutions.
All companies need to follow the same set of regulations; however, each company has a different culture and organizational structure. The areas of Research and Development (R&D) and post-approval functions are grossly under-served when it comes to Compliance and Quality.
I want to help change that.