Consulting Services

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The scope of EPC services address multiple aspects of both company and product lifecycle management including:

Initialization

  • In-licensing Assistance and Negotiations
  • Due Diligence
    - Evaluation of Product Portfolios
    - Funding Strategies
    - GAP Analysis
    - Intellectual Property Reviews
    - Regulatory Strategic Plans
  • Cross-functional Team Building
  • Competitive Intelligence
  • Building Scientific Advisory Boards
  • Development, Review and Implementation of Business Plans

Operations

  • Prioritizing Development Plans and Setting Milestones
  • Establishing Successful Project Management
    - Pre-clinical
    - Clinical
    - CMC
  • Selection and Management of Service Organizations
    - Formulation Development, Analytical, Clinical, Operations
    - Clinical & Commercial Manufacturing, Supply Chain Optimization
    - Commercialization and Ancillary Services
  • Regulatory Agency Assistance
    - Guidance Clarification
    - Regulatory Agent
    - Regulatory Meetings and Responses
  • Pre-meeting Packages
    - Global Regulatory Filings
  • IND/IMPD/NDA/NDS/MAA/PMA/BLA/510k Applications
  • Annual Reports
  • Orphan Drug Applications
    - Regulatory Agency Negotiations and Meeting Preparation
    - Responses to Regulatory Actions
    - Label Negotiation
  • Quality Oversight
    - Review and Advice
    - Audit Preparation and Auditing
  • Formulation Development and Selection
  • Clinical and Commercial Manufacturing Assistance
  • Materials Sourcing

Corporate Planning, Finance & Funding

  • Market Analysis and Forecasting
  • Business Asset Valuation
  • Business and Development Plans
  • Corporate Development Strategic Consulting
  • Incorporating NewCo's and Capitalization
  • Strategic Partnering
  • Launching and Growing Virtual Organizations
  • Guidance, Insight and Assistance
    - Private Placement, Venture Capital, Angel Investors, Wall Street

Commercialization

  • Brand Creation
  • Product Launches
  • Strategic Partnering
  • Development of Marketing Plans and Surveys
  • Outsourcing Key Functional Areas
  • Strategic Management

About EPC
EPC is an integrated global biotech consulting and product development company. Our priority is to maximize the efficiency of the development process by eliminating unnecessary expense or work, proactively identifying issues in a straightforward manner, and facilitating interactions with regulatory agencies, financiers and outside vendors.

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Our team is there to help your team, no matter how complex or how simple the assignment. We are willing to roll up our sleeves and work closely with your team to optimize your project.

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The scope of EPC services addresses multiple aspects of both company and product lifecycle management including initialization, operations, corporate planning, finance & funding and commercialization.

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