Services

JGB BioPharma Consulting Inc. provides consulting and personnel placement services in the biopharma, medical device, and diagnostics industries.Our clients include start-up biotech companies, established pharmaceutical companies, venture capital firms, and diagnostics and device companies. JGB BioPharma saves you time by providing consulting expertise in all areas of Drug and Device development.

Some of the areas we focus on include:

• Clinical Research and Operations
• Product Development
• Project Management
• Quality and Audits
• CMC
• Corporate Development
• Personnel Placement

Clinical Research and Operations:

• Specialty MDs (Oncology, Opthomology, Autoimmune Diseases etc.); MDs with years of industry experience
• Clinical Strategy
• Protocol creation
• Clinical Project Management/ Operations
• Technical writing: Investigator Brochures, Protocols, Final Study Reports, SOPs for GCPs
• CRO Managment; Investigator Site Selection
• Study Initiation, Monitoring, and Close-out visits (Regional Monitors)
• Timelines and resources (Microsoft Project)
• Study budget creation & negotiation
• CRO Selection/ Contract Negotiations
• Safety/ Pharmacovigilence
• Data Management
• Biostatistics
• Statistical Programming

Product Development:

• Scenario analyses by indication, cost, market size
• Product development plans
• Strategic development

Project Management:

• Manage pre-clinical, clinical, or CMC
• Pre-IND to NDA submission; preparation for PAI and launch
• Implementing project management systems
• Running or Leading teams or subteams
• Liaison with corporate partners
• Establishing budgets, timelines, milestones for a project or department
• Microsoft Project expertise
• Acting Department Head (Project Managment, Project Leader, Product Development, Alliance Management)
• Established record of placing excellent project management staff from the coordinator to executive level

Quality and Audits

• Quality Assurance and Quality Control SOP Review and Creation
• Audits: GCP, GLP, GMP
• Batch Record Review
• Department Leadership
• Qualtiy Systems

CMC:

• Selecting and Managing CMOs
• Formulations expertise
• Process Development
• Manufacturing
• CMC Leadership
• CMC Technical Writing

Corporate Development:

• Creation of presentations and documents for potential partners
• Identifying & establishing contacts with potential collaborators
• Market, competitor research and product positioning
• Technology assessment (i.e., finding the best drug delivery company)

Personnel Placement:

• Finding the right talent for your company. Specializing in all positions in Drug and Device Development such as:
  • Project Management and Leadership
  • Clinical Research and Operations
  • Biostatistics
  • Data Management
  • Statistical Programming
  • Regulatory Affairs
  • Quality (QA and QC)
  • Formulations
  • Process Development
  • Manufacturing
• Established network
• Thorough screening interview

For Employers who would like to hear more about these services, please contact Julie@JGBBioPharma.com

For Job Seekers, please check for current job opportunities