BioPoint is a leading global Life Science consulting firm. We partner with Medical Device organizations to provide consulting services and flexible workforce solutions that help optimize product development from concept to post-market. BioPoint’s expertise encompasses a wide array of therapeutic areas and classifications for devices, combination products and diagnostics.
Specialties
Specialization, Flexibility, Results
BioPoint’s customized offerings include both strategic leadership and tactical support within the Regulatory, Quality, Clinical, Safety & Surveillance and HEOR / Market Access functions.
Clinical
Study Design/Analysis
> Biostatistics & Programming
Site Selection, Qualification, and Initiation
Study Management & Vendor Oversight
Clinical Data Management
Medical Writing – Clinical & Regulatory
>Protocols, IB’s, ICFs, CRFs, Monitoring Plans, CSRs, Scientific Publications, etc.
Clinical Evaluation Strategy and Writing – EU MDR / IVDR
> Gap Assessment & Transition Roadmap
> Literature Reviews
> Clinical Development Plans (CDPs)
> Clinical Evaluation Plans (CEPs)
> Clinical Evaluation Reports (CERs)
Regulatory
Regulatory Strategy and Health Authority Interaction
> Preparation & Facilitation for Regulatory Body Correspondence (US/EU/ROW)
> Submission Planning, Launch and Post-approval Guidance
> PMA/510k/De Novo/IDE/HDE/Design History File
> Design Dossier/Technical Files for CE Marking
Regulatory Operations
> Submission Development & Formatting
> Packaging, Labeling and Artwork Solutions
> User Manual Updates
> UDI
Regulatory Intelligence & Policy
> Global Landscape Surveillance
> Optimization of New & Existing Marketing Privileges
Quality
Navigation of Domestic and International Standards / Regulations
> 21 CFR Part 820 & 13485 integration, Part 11
> ISO 13485, 9001, 14971
> IEC 60601, 62304, 62366
Strategic Planning for EU MDR / IVDR Adoption
Quality System Implementation and Maintenance
Software & System Validation
Auditing and Inspection Readiness (MDSAP,FDA,ISO)
> Virtual & On-site Capabilities
> Gap Analysis
>Mock & Pre-audits
> Internal Audits
> Supplier Audits
Remediation of Quality & Compliance Issues
Safety & Surveillance
AE/SAE & Product Complaint Assessment, Investigation and Reporting
> Safety Database Support via case system migration, transition and/or upgrade
> Development of robust surveillance tools
Develop and Review of key clinical & post-marketed Risk Management documents
> Risk Management Plans & Reports
> Product Hazard Assessments & Evaluations
> Design FMEAs
Prepare safety statements for relevant communications purposes such as DHCP letters
Author required surveillance documents – PSURS, PMSP, PMSRs, SSCPs, PMCFs, etc.
Signal detection and monitoring medical safety profile for pre & post-marketed products
Epidemiological Research & Design
HEOR & Market Access
RWE Generation Strategy and Analysis Supporting Value Proposition
> Observation Study Design
> COA Development & Validation
> Economic Modeling, Statistical Analysis and Programming
> Cost-effectiveness
> Budget Impact
> Global Value Dossier Development
> Publication, Manuscript and Abstract Design
Global Market Assessment Ensuring Successful Product Positioning
Coverage & Reimbursement Analysis, Strategy and Implementation
> Payer Mix Selection through Patient Demographics and Site of Service analysis
> Influential Stakeholder Identification & Interaction
> Regulation / Policy Navigation
> Coding Assessment & Development Activities
> CPT, ICD, HCPCS