a) Project management & site upgrade

Project Definition

  • Project Basis & Chart

Process

  • Process map
  • Flow Diagram
  • Material Balance
  • Specification
  • Raw Materials
  • Specification of Finished Products

Layout, Material flow, Personnel Flow, Hygienic Zones

  • General layout
  • Material Flow
  • Personnel flow
  • HygienicZoning
  • If needed / Hazardous Area

Upgrade of Existing Facilities:

System Evaluation and preparation

Preparation of Working Plan

Gap Analysis

  • Production efficiency
  • Quality system
  • Layouts
  • Air Handling System
  • Utility System

Layout, Material Flow, Personnel Flow, HygienicZones

  • Preparation of fresh layout drawings
  • MaterialsFlow
  • Personnel flow
  • Hygienic Zoning
  • Explosion / Hazardous Area

b)  Third Party Audits

(Supports Pharmaceutical and Medical Devices manufacturers in performing many kinds of audits, conducted worldwide by our lead auditors that have a minimum of 15 years of field experience) for both routine and due diligence audits.

  • Manufacturers of API, Excipients and Intermediates
  • Due diligence Audit for GxP Compliance IT Systems and Business Plan Challenging
  1. Compliance &Quality

Overall we will support you to find the most sustainable way to develop practical and tailored plans that align global quality capabilities with your business strategy.

  • Quality Metrics
  • Compliance Strategies
  • Continuous Improvement and Performance Metrics Implementation
  • Quality System Implementation
  • Quality Structures (QC, QA, RA) Assessments for Skills and Staffing
  • Inspection Readiness Master Plans
  • Training Systems Implementation / Mentoring / Coaching
  1. Strategic advice & Facilitate Market
  • To ‘build, borrow or buy’ new technologies in anticipation of future customer needs and market requirements, by creating visions of what the future might hold.
  • By helping our clients understand complex technical situations, we ensure their technologies deliver commercial success in rapidly evolving markets.
  • Business plans often fail to capture the versatility needed to manage uncertainty. Our approach enables rapid, practical decision-making by covering not only the ‘what?’ but the ‘why?’, ‘how?’, ‘when?’, ‘where?’ and ‘for whom?’
  • We draw on internal and external expertise to understand markets, opportunity spaces and the competitive intensity in those spaces, complementing our clients’ in-house capabilities.
  1. Regulatory Strategy & Implantation Facilitating
  • EPG supports customers through both the entire drug and medical devices regulatory lifecycles, providing a full range of regulatory activities
  • Worldwide Regulatory Strategy
  • Dossier Gap Analysis & Review for Drug Products and Drug Substances
  1. Due Diligence
  • Buying a business is a calculated risk. What may seem attractive from the outside may look entirely different once an acquirer takes full control. That’s why due diligence is such an important step. Done right, it helps acquirers minimize risk and gives them confidence that they can actually create sustainable value through the acquisition.
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