Business Model

We invest deeply in identifying, evaluating, and onboarding the right manufacturing partners so you don’t have to. Every facility undergoes a structured, multi-dimensional assessment covering:

• Technical Capability & Process Chemistry Fit
  Evaluation of reaction expertise, handling capabilities, technology platforms, and scale readiness.

• cGMP & Quality Systems Audits
  Rigorous audits to verify compliance, documentation practices, data integrity, and quality culture.

• Regulatory Standing & Inspection History
  Review of USFDA, EU, WHO, PMDA, and other regulatory inspection outcomes and overall compliance maturity.

• EHS & Sustainability Checks
  Assessment of environmental footprint, waste-handling systems, worker safety, and ESG alignment.

• Financial & Operational Robustness
  Ensuring the partner has the stability, infrastructure, and governance to support long-term supply commitments.

Once qualified, Aster builds strategic, future-ready partnerships that enable predictable scale and supply continuity.

• Preferred or Exclusive Supply Agreements
  Securing priority allocation and strengthening reliability across product lifecycles.

• Reserved Capacity for Priority Molecules
  Guaranteed production windows ensure uninterrupted scale-up and commercial supply.

• Joint Development for Complex Intermediates
  Co-engineering solutions for challenging chemistry, achieving faster speed-to-market.

• Periodic Re-audits & Continuous Quality Monitoring
  Governance systems maintain compliance, consistency, and continuous enhancement.

We work as an extension of your sourcing, development, and regulatory teams, ensuring seamless project execution.

• Requirement & Risk Analysis
  Understanding your technical, regulatory, and commercial expectations to guide partner selection.

• Matching to the Optimal Manufacturing Partner(s)
  Aligning the right capabilities with your project’s complexity, timelines, and compliance needs.

• Documentation & Regulatory Package Preparation
  Supporting dossiers, technical files, and regulatory submissions to meet global standards.

• Tech Transfer & Scale-Up Coordination
  Ensuring smooth knowledge transfer—from lab to pilot to commercial scale.

• Ongoing Supply & Quality Oversight
  Proactive oversight to maintain consistency, manage deviations, and drive continuous improvement.

Our role does not end with successful supply; we continuously optimize your sourcing ecosystem.

• Supply Chain Risk Tracking
  Mapping vulnerabilities and building long-term resilience through proactive controls.

• Regulatory Intelligence Updates
  Monitoring global regulatory developments that may impact compliance or market access.

• Process Optimisation & COGS Reviews
  Improving yields, reducing costs, and enhancing sustainability through scientific and operational upgrades.

• Alternative & Dual Sourcing Strategies
  Safeguarding reliability with qualified backups and risk-mitigation pathways.