Quality Integrations: Building Success Through People, Product, Process, & Retention
P3R Quality manages a complex company or asset integrations while your internal Quality team stays focused on their day-to-day priorities.
The integration story will be Inspection-Ready well before the asset(s) are ready for Marketing Applications.
Every new company or asset purchase is Unique and there WILL be surprises.
P3R Quality works alongside your Quality team to manage changes related to pipeline expansion- including new products, QMS/E-Systems, portfolios, new modalities, facilities, expertise.
P3R stands for: People, Product, Process and Retention.
Mitigate risks & issues identified during company and asset integrations.
Welcome your new People with professionalism, clarity, and a well-constructed integration plan, reducing stress and preserving knowledge during a period of uncertainty.
Bring order, decision-making, and focus to the chaotic phase of integrations.
Handle Change management, operational streamlining, SOP harmonization, QMS consolidation and optimization.
Leverage synergies to bring newly acquired asset(s) to market faster.
Ensure knowledge retention and knowledge transfer from incoming People.
Be inspection-ready to defend the integration story years before Marketing Applications.
“Tressa has the right experience to help our small biotech with its first clinical stage integration. She can navigate the choppy waters, the unexpected surprises.”
About Me
Tressa Allington, PhD
Tressa has over 15 years of experience in biopharmaceutical development including therapies for rare diseases, neurology, metabolics, oncology, hematology, and gene therapies. She has led more than 10 small company integrations from a Quality perspective, defending integration records for MHRA, EMA, and FDA inspections. She is comfortable working with all biotech functions that support integration -such as IT, Operations, R&D, HR, Tax, Finance, & Portfolio Management. She supports most effectively embedded with your Quality team, working collaboratively across all areas that are over-extended by an acquisition. Her primary areas of expertise are: GLP, GCP, risk management, data integrity, laboratory operations, and inspection readiness.
She has a bachelor’s degree in Chemical Engineering and a PhD in Pharmacology. Tressa resides in the metro Denver area of Colorado and is available for domestic and global travel as needed.