The Leader in Life Science Consulting Services
The life sciences industry is a dynamic environment, presenting new challenges and opportunities to the companies in it. As global Regulatory, Safety / Pharmacovigilance, and Market Access requirements continue to become increasingly complex and demanding throughout the product lifecycle, it is critical to have the human capital necessary to meet your goals. That’s where BioPoint comes in.
Having partnered with over 80 Life Science clients to support each of these key functional areas, we have the practical hands-on experience and focus to efficiently address your resource gaps and project deliverables. BioPoint’s consultants act as a direct extension of your staff, easily accessible to provide innovative solutions every step of the way. Whether you require a fixed SOW project based engagement or a Functional Service Provider model, BioPoint can tailor our services to your unique business needs and project scope.
Specialized Consulting Services
BioPoint’s experienced and knowledgeable team helps clients across the pharmaceutical and medical device sector navigate through crucial Regulatory, Product Safety, and Market Access landscapes to successfully bring their products to market. Our client-driven, flexible engagement models can present experts on an as-needed, just-in-time consulting basis, working remotely or embedded onsite with your group. Whether your project calls for tactical reinforcement or specialized strategic guidance, we can help.
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- Pharmacovigilance, Drug Safety & Risk Management Consulting – Case Intake, Case Processing, Case Assessment, Signal Detection, Risk Management, Benefit/Risk Assessment, REMS, Pharmacoepidemiology
- Regulatory Affairs Services – Regulatory Submissions, Biologic Formulations, Medical Writing, Regulatory Strategy, Advertising & Promotion, Labeling, CMC, Submissions Management
- Market Access / HEOR Consulting – Observational Study Design, Claims Analysis, Literature Review, Model Development, PRO Design, GVD Development
- Quality Assurance Consulting – Internal & External GXP Compliance and Auditing, Validation, SOP Development, Quality Systems Assessment, Development, Enhancement.
- Clinical Operations & Biometrics – Clinical Trial Management, Medical Monitoring, Clinical Data Management, Biostatistics, GCP Audit, SOP Creation, CRO Evaluation.
- Clinical Development Consulting – Clinical Development Strategy, Clinical Development Plans, Dossier & Submission Preparation, Competitive Landscape Mapping, Clinical Data Cleansing & Review, TPP and Protocol Development.
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