BioPoint Inc

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.

• 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.

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.

Secure the Experts You Need, When You Need Them

Our subject matter experts look forward to bringing unique capabilities and approaches to your company, no matter the situation at hand. Whether it’s for a highly specialized task or larger, more diverse tasks, our services are shaped to meet your needs. To learn more about our consulting services, and to identify the expertise your company may need, be sure to contact BioPoint today.