Bio-Pharma is an industry leading Talent As A Service (TAAS) Platform that provides vetted, elite leaders and subject matter experts to help Life Science businesses solve their toughest problems.

Our clients use Bio-Pharma platform’s “On Demand” Services when they need highly specialized leadership professionals at highly competitive rates. They also use our platform when they need Subject Matter Experts with specific project backgrounds who can hit the ground running and meet challenging budget and time constraints.

Companies ranging from venture backed start-ups to Fortune 500s have trusted us with numerous engagements. Utilizing our robust, referral-generated platform of highly skilled professionals, and agencies, our clients always get the expertise they need. Our seasoned experts not only solve problems, but add to the knowledge and skills that are a necessity for clients’ long term success.

At Bio-Pharma our mission is simple, we strive to develop and deliver effective, competitive and practical business solutions for small, medium, and large organizations specializing in Biotechnology, Medical Device and Pharmaceutical Industries – that allow these organizations to optimize their operational efficiency and maximize Return on Investment in time and under budget.

QUALITY ASSURANCE & CONTROL

Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Warning Letter & Consent Decree prevention/remediation
  • 483 Responses
  • Remediation
  • Design History Files
  • Device Master Records
  • Drug Master Files
  • Risk Management
  • CAPA and Adverse Events (AE)
  • Document Control including Labeling
  • Complaint management & complaint systems
  • Quality Systems
  • Supplier Quality assessments, relationship management, and remediation
  • GXP Consultants: GMP, GLP, GCP
  • Quality and Reliability engineers
  • 3rd Party Experts

REGULATORY AFFAIRS

Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Global Submissions & Approvals
  • Drug: IND, A/NDA, BLA, CBE, DMF Amendment, EMA
  • Device: IDE, 510(k), PMA, CE Marking Design Dossiers/Technical Files
  • Regulatory Subject Matter Experts & Strategists including specific approval pathway consulting
  • Licensing, Packaging, and Labeling Approvals
  • Technical Transfers, CMC, & new manufacturing site documentations and submissions
  • Life Cycle Management
  • Remediation Projects
  • Site & Documentation Audits
  • FDA Liaison

MANUFACTURING AND SUPPLY CHAIN

Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Tech Transfers
  • Site Separation and Relocation
  • Product Expansion and Launch
  • Chemical, Manufacturing, and Controls (CMC)
  • Supplier Quality
  • Supply Chain Sourcing
  • New Manufacturing Plants
  • Raw Materials & API Development

RESEARCH AND DEVELOPMENT

Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Total Product Life Cycle (TPLC) from initial concept to product retirement
  • Cross-functional and Clinical leadership (Phases 1 – 4)
  • R&D PMO Tools and Processes
  • Clinical Trial design, management, and data management (CTMS)
  • Clinical Compliance: Sites, Protocols, Study Reports
  • Pipeline & Portfolio Management
  • Therapeutic Area (TA) Subject Matter Experts including study physicians scientists, Medical monitors, and principle & reliability engineers
  • Combination devices and software interactions
  • Benchmarking Strategy & Analysis

MEDICAL AFFAIRS

Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Global Affairs Strategy & Operations
  • Organizational Change Management, Communications & Training
  • Therapeutic Area (TA) and Disease specific support including physicians/scientists and medical monitors
  • Pharmacovigilance and Medical Safety
  • Compliance Operations
  • Product Launch Strategy & Support
  • Key Opinion Leader (KOL) Facilitation and Management

Commercial & Marketing

Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Product Launch
  • Strategy
  • Processes and Improvements
  • Training
  • Execution
  • Commercial Strategy & Optimization
  • Product expansion into new global markets
  • Promotions and Product Labeling
  • LCM (Life Cycle Management) & Product Defense
  • Global Medical Communications and Event Management
  • Acquisition and Divestiture logistics
  • Insights and Analytics
  • Market Research and Analytics

Shared Services

Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Global Software Implementations (ERP, PLM, CRO, PPM, etc)
  • Integration & Separation Activities
  • Business and Functional Analysis
  • Business, Enterprise, and Solution Architecture
  • Data Management
  • Interim Leadership

Program Management Office (PMO)

Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • PMO Creation and Process Development
  • PMO/PPM Tool Implementation and Adoption
  • Portfolio Management
  • PMO Maturity level assessments, strategy, and improvement
  • Resource and Demand Management
  • Communication and Training
  • Dashboard design and creation

M&A, Integrations, Divestures

Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Separation/Merger/Divestiture Planning & Transformation
  • Master Data, Records, and Document Management
  • Transitional Service Agreements (TSAs)
  • Process/SOP Integration & Alignment
  • Renaming and labeling changes
  • Organizational Change Management & Training
  • Sales and Reporting Integration

Resume Review

Work with a resume review coach to turn your existing resume into an eye-catching, ATS-beating doc that clearly tells hiring managers why they should bring you in for an interview.

LEVEL INCLUDED IN THIS PACKAGE PRICE
Individual Contributors
  • An update resume from your coach
  • An update resume from your coach
  • An update resume from your coach
$60/hrs
Supervisors
  • An update resume from your coach
  • An update resume from your coach
  • An update resume from your coach
$75/hrs
Managers
  • An update resume from your coach
  • An update resume from your coach
  • An update resume from your coach
$95/hrs
Directors
  • An update resume from your coach
  • An update resume from your coach
  • An update resume from your coach
$125/hrs
VPs
  • An update resume from your coach
  • An update resume from your coach
  • An update resume from your coach
$160/hrs
Executive Leadership
  • An update resume from your coach
  • An update resume from your coach
  • An update resume from your coach
$300/hrs