Pharma | Bio Tech | Med Device

Commercial, Sales & Marketing

Field Sales Effectiveness

New Product Launches

CRM - SalesForce.com

Product Sample Drop & Signature Capture

Distributor On-Boarding & Launches

International Sales & Marketing

R&D, Manufacturing

Early Development Product Portfolio Tracking

Regulatory Product Data Tracking

Regulatory Product Publishing eCDT

Regulatory Document Storage & Tracking

Supply Chain Integrations

Contract Manufacturing On-boarding

Distribution Center Process Effectiveness

3PL Integrations & Process Effectiveness

 

 

"C" Suite & Corporate Functions

Post Merger & Bolt-On Acquisition Execution

Corporate Integrity Agreements Compliance

Regulatory Changes & Audit Compliance

Shared Service Center Road Mapping

Shared Service Centers (Finance, HR, Legal, Procurement)

Project Management Office Stand-ups & Resource Partnering

Contract to Pay Process Effectiveness

 

 

 

Commercial, Sales & Marketing - Business Cases

  • Field Sales (Mobility, CRM, Sampling) - Our initiative  introduced compliant mobile signature capture at the point of sample drop e.g. physician’s office. Allowed Field Sales Force the ability to “go paperless” and rely completely on their mobile tablets for all CRM and sample capabilities. Supply chain interconnectedness automatically procured a sample order and allowed for drop ship delivery or trunk stock hand delivery.

  • Marketing (New Product Release, Physician Training) - Designed and introduced a self service training portal to help increase the efficacy of an injectible medical device. The training was not mandated as part of the new drug’s regulatory approval, but elected by the company to ensure additional patient safety and product effectiveness. The product training portal confirmed good license standing, displayed a training video, recorded training results and initiated a sample product kit.

 

Research & Development - Business Cases

  • Regulatory Affairs (Product Tracking, Regulatory Submissions) - Streamlined the world-wide regulatory submissions process to help better support R&D (Development, Pre-Clinical, Clinical, Medical Affairs), and Commercial groups. The initiative allowed colleagues that support Regulatory Affairs functions in-market to better share and re-use critical data when applying or responding to country specific regulatory bodies (e.g. FDA, EMA, MHRA). Allowed Corporate R&D Product Portfolio Management more timely and accurate data to analyze and track the exact approval cycle stage per product (SKU) for each global region.

  • Regulatory Affairs (Product Tracking, Regulatory Submissions) - Introduced new processes & systems to help speed submissions to regulatory bodies (e.g. FDA, EMA, MHRA) by way of electronic common technical documents (eCDTs).  Electronic submission adoption increased for world-wide regions, as electronic submissions become the defacto standard for NDAs, ANDAs, New Indications, etc.. a global data privacy collection and sharing strategy.

 

 

 

Manufacturing & Supply Chain - Business Cases

  • Supply Chain (Distribution Centers, Mergers and Acquisitions) - Consolidated North American distribution centers to a single outsourced third party logistics provider as part of a consolidation and efficiencies plan.

  • Supply Chain (Integration, Wholesalers) - Upgraded mission critical wholesaler purchase ordering platform to improve just in time inventory performance and order fulfillment.

  • Manufacturing (Contract Manufacturers) - Facilitated the on-boarding of a new CMO onto SAP Manufacturing module.

 

Coporate Functions - Business Cases

  • We have consulted and advised on a wide array of projects related to the following areas:  Category Spend Analysis, Supplier Consolidations, Catalog Expansion & Enhancements, Contracting Process Enhancements, Electronic Signature Capture, SOX Compliance, ICOFR (Internal Controls over Financial Reporting), E-Discovery, and Intellectual Property & Patent Tracking.

 

-- Diagnostic Check-Up --

1)  Need to flawlessly execute a strategy, system implementation, or operational improvement project in the next 90 days?

2)  Do you want breakthrough results that generate 10-20X return on investment?

3) Are you looking for an alternative to “Big Box Consulting Firms”?

 

If you answered "YES" to ANY of these questions, let's talk!

Email: info(at)compassx.com

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