Sales & Marketing

When your products are ready, you’ll want to find global buyers. Ardezen has a strong relationship base with companies all over the world looking for novel medicines. Formats vary depending on timing.  No matter what we can help with:

  • B2B lead generation
  • Presentation creation and updates (PPTS. SOPs, CoAs)
  • Market entry assessments
  • M&A support
  • Distribution partner introductions
  • Representation at industry events

Regulatory

Your regulatory accreditations will be one of the most critical aspects of your journey. Consideration of how your products will meet domestic and international standards needs to be introduced early to avoid delays in time and increases of spend. Ardezen helps with:

  • International & domestic regulatory analysis.
  • Import & export strategy development.
  • Manufacturing & supply pathway development.
  • Client representation & advocacv to ODC. TGA & State/Territories Regulators.
  • International & domestic regulatory intelligence
  • (Technical Monographs, Guidelines & Business Operations).
  • Drafting. review & submission of regulatory applications.

Operational Excellence

Once your infrastructure is developed, you will need the tools, practices and processes to run an efficient operation. The Ardezen team can support your operation with:

  • Manufacturing Execution System (MES) implementation & support.
  • Production Planning & Forecasting.
  • Lean Manufacturing Systems & Processes.
  • Data Analysis.
  • Daily Direction Setting.

Supply Chain & Globalisation

Having a strong understanding of each markets regulatory pathways and ensuring products get the appropriate approvals for import and export is critical when you go global. The Ardezen team can support your project with:

  • Assist clients in the creation and optimization of SOPs.
  • Strategic advice on areas to reduce risk and introduce agility within the supply chain (end to end).
  • Create implementation strategies to improve on existing supplier relationships
  • Stock inventory planning and management – review and implementation.
  • Oversight of global regulatory and product submission packages to obtain product approvals.
  • Identify and assist in the qualification of bulk raw materials / API manufacture’s/ packaging and device components – due diligence.
  • Participate in client facing discussions

Ardezen Service Offering Lifecycle

Bussiness Development
Project Management
GMP
Compliance
& Regulatory
Affairs
Supply Chain Management
Operational Excellence
  • B2B Lead Generation
  • Market Entry Assessments
  • M&A Support
  • Distribution Partner
  • Introduction

  • Advisory & Strategic
  • GMP Project Design.
  • Development & Delivery
  • Cannabis – Seed to Sale Solutions
  • Client Advocacy

  • Regulatory Affairs (ODC & TGA)
  • Quality Management Systems
  • Technical Documentation & Validation
  • Import & Export Strategy Development

  • End to End Supply Chain Management
  • Qualification of Controlled Materials
  • Client Advocacy
  • Supply Chain Risk Mitigation

  • Lean Manufacturing Principles
  • Facilities Management
  • Operations Management