Biotech & Pharmaceutical Consulting Firm

Biotech and pharmaceutical businesses need to have the expertise to keep up with the rapidly evolving complexity of their industries. This is why many turn to GForce Life Sciences when they need a biotech/pharmaceutical consulting firm that can connect them to the resources they need. Whether they want to augment their staff, need expertise on a project basis or have to find executive leadership to guide them into the future, we are there to help.

 

Our pharmaceutical and biotechnology consulting capabilities enable us to fulfill a wide range of requirements. From experience regarding medical device development and manufacturing to serving as a functional service provider during clinical trials, few other pharma or biotech consultants have the combination of resource delivery models that we do. You can depend on us to hand-pick and closely monitor the pharmaceutical consultants that best fit your company and projects.

 

A Completely Tailored Approach

 

We don’t believe in providing a one-size-fits-all service. Unlike many other biotech and pharmaceutical industry consultants, we take a close look at your individual needs and develop a plan that is yours and yours alone. Our capabilities as they pertain to consulting, staff augmentation, subject matter expertise and executive searches can be combined in any way that suits your specific requirements. It is this commitment to tailored services that makes us unique among biotech and pharmaceutical strategy consulting firms.

 

To learn more about our pharmaceutical and biotech consulting or any of our other services, get in touch with us today to get started on addressing your needs.

Clinical
Development
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  • Clinical Development Plan Design (Phase I – IV)

  • Program Resource

  • Planning & Budgeting

  • Cross-Functional Asset Development

  • Clinical Development Teams

  • Strategic Program Planning & Resourcing

  • Asset Pipeline & Lifecycle Management

  • CDP Risk Management & Mitigation 

  • Translational Development Transition & Management

  • Laboratory Information Management System (LIMS)

Clinical
Operations
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  • Clinical Project Management Phase I – IV  

  • Study & Site Management 

  • CRO & Vendor Selection & Management

  • Site Contracts & Budgets

  • Site Monitoring

  • SOP Development & Compliance

  • TMF Management

  • Project Budget Analytics

  • Clinical Staff Coaching & Mentoring 

  • High Performing Functional Leads

  • Competitive Intelligence & Metrics (Dashboards)

  • Laboratory Information Management System (LIMS)

Quality
Assurance

  • Quality Management Systems

  • QA SOP Development

  • Site & Vendor Qualification & Auditing (GCP, GLP, CLIA Accreditation)

  • Internal Sponsor SOP Audits

  • Process Deviation & CAPA Management

  • Harmonization & Validation

  • Sponsor & Regulatory Inspection Readiness

  • Manufacturing Oversight (GMP)

  • Computer Systems Validation

Medical
Writing
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  • Document Quality Assurance

  • CSR & Clinical Protocols

  • Publications & Manuscripts

  • Regulatory Documents (CMC, clinical & non-clinical)

  • Document Development SOPs

  • Submission Document Management

Data
Management
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  • Project Management

  • Data Management Plan

  • CRF Designing

  • Customized Database Design, Screen Testing & Development

  • Edit, Validation and Design check programming, UAT

  • Data Validation

  • Data Cleaning

  • Local Lab Data Management

  • Patient Diary Data Management

  • Serious Adverse Event (SAE) Reconciliation

  • Manual / SAS® Data Listings Review

  • Quality Control – Sample QC & Critical QC and Data Quality Audits

  • Database Soft & Hard Lock and Export to SAS®

Medical
Affairs

  • Health Economics & Outcomes Research (HEOR)

  • Medical Information 

  • Medical Communications 

  • Portfolio & Asset Lifecycle Management

  • Study Design (Phase IV & Registry Studies)

  • Early Phase Indication, Epidemiology & Patient Assessment

Safety & Pharmacovigilance
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  • Clinical & Marketed Case Safety Reports

  • Region Specific & Aggregated Safety Reports

  • Scientific Literature Surveillance

  • Safety Signal Recognition & Analysis

  • Safety Risk Management

Regulatory
Affairs

  • International Asset Registration & Licensing  

  • Technology Transfer & Asset Integration  

  • Label Development & Review

  • Regulatory Operations Support

  • Regulatory Project Management

  • Regulatory Activity SOP Development 

  • FDA & EU (483 Observations, Warning Letters, Consent Decrees) Remediation

Project & Program Management

  • Program & Project Planning

  • Resource Allocation & Management

  • Budget Establishment, Analysis & Tracking

  • Project Scope Definition

  • Coach, Mentor & Train others PMs

  • Functional Leaders & Team Members

  • Success Measures & Metrics (Dashboards)

  • Assessments

  • PMO & PPM

Pharmaceutical Operations & Technology 

  • Operations & Manufacturing Strategy 

  • Process Development

  • Technical Transfer

  • Innovation & Product Development

  • Sourcing & Procurement

  • Integrated Planning & Analytics

  • Supplier Compliance

  • Contract Manufacturing Oversight

Audits

  • Quality Management System (QMS)

  • Baseline or Gap Assessment

  • Inspection Readiness

  • GMP, GCP, GLP

  • Supplier/Distributor

  • Contract Manufacturer

  • ISO 9001

  • 21 CFR Part 210 & 211

  • 21 CFR Part 11

  • Auditor Training