John Meijer Email and Phone Number

PeaK Bioanalytical ConsultingPeaK Bioanalytical Consulting offers bioanalytical consultancy and (interim) bioanalytical project management services. I have a professional attitude underpinned by dedication and open communication lines with the client. Peak provides detailed knowledge of relevant regulatory guidances (FDA, EMA, PMDA), submissions to regulatory authorities and outsourcing of bioanalytical programs.Tailored approach to clientsPeaK provides bioanalytical solutions and services fitting your needs, well balanced between time, cost, and quality. My methodology:1. Create an overview of bioanalytical requirements for your development program,2. design a fit-for-purpose BA strategy to satisfy these requirements, 3. monitor progress of project milestones towards goals, and,4. based on study results, reassess requirements and adjust the BA strategy where necessary.The above steps provide you with the tools to control your BA studies during the entire drug development program until regulatory submission and avoid unexpected budget or regulatory surprises.Services include:BA consultancy:• Assessment of the clinical development plan and creating a robust BA strategy;• Selection of BA technologies and evaluation of BA-methods;• Selection, monitoring and evaluation of CROs;• Due diligence of existing BA-packages;• BA-packages for regulatory submissions, gap analysis, risk mitigation, Q&A with regulators;• Authoring and reviewing bioanalytical sections in clinical documents;• Creating and reviewing BA SOPs and guidances;• Quality monitoring, metrics, KPIs;• Bioanalytical sample life cycle management and sample logistics;(Interim) Project management:• Managing BA validation and analytical studies (if needed via insourcing);• Project- and program management;• Technical writing.Feel the chemistry? Please contact me for further information or to make an appointment!