solutions

Aster supports discovery teams and early clinical developers with fast, flexible, and high-compliance manufacturing options. We recognise that the earliest stages of drug development demand agility, precise execution, and rapid technical turnaround.

Our solutions give you:

• Instant access to pre-qualified partners capable of producing GLP toxicology batches and early GMP material under short timelines.

• Flexible production scales, enabling smooth transitions from milligrams and grams used in discovery to pilot-scale batches for Phase I studies.

• IND/CTA-ready documentation, robust analytical support, impurity profiling, and stability data tailored to global regulatory expectations.

Whether you are preparing for in-vivo studies or gearing up for first-in-human trials, our network ensures scientific reliability and accelerated speed-to-material.

Emerging biotech companies face a critical challenge when moving from promising clinical data to commercial readiness: they must quickly scale manufacturing, strengthen regulatory foundations, and build resilient supply chains—all without compromising speed or quality.

Aster provides a structured pathway for this transition:

• Manufacturing partners with proven FDA, EMA, and PMDA credentials, ensuring confidence for pivotal trials and commercial filings.

• Commercial-scale API capacity, including dual-sourcing strategies for risk mitigation and supply security.

• Comprehensive DMF/CMC support, documentation alignment, and regulatory intelligence designed to streamline global submissions.

We act as an extension of your technical and regulatory teams, helping you scale efficiently while maintaining the robustness required for late-stage development.

Generics companies operate in a highly competitive marketplace where cost, quality, and regulatory readiness determine long-term success. Aster helps established generic manufacturers strengthen their sourcing strategies and expand their portfolios profitably.

Our offering includes:

• Access to India’s most competitive, quality-assured API manufacturers, each pre-audited for compliance and operational robustness.

• ANDA-ready documentation, including complete DMFs, CEPs, stability studies, and analytical validation data to support rapid regulatory approvals.

• Multi-product sourcing relationships that consolidate supply chains, reduce administrative burden, and create long-term commercial advantages.

We bring cost efficiency without compromising compliance, allowing generic companies to launch reliably and scale sustainably.

Innovator and specialty pharma companies developing complex molecules require more than standard manufacturing—they need specialised chemistry, advanced containment infrastructure, and continuous scientific collaboration.

Aster supports these high-value programs through:

• Expertise in chiral chemistry, high-potency APIs (HPAPIs), and oncology molecules, along with facilities equipped for contained handling and specialised analytics.

• Route optimisation, impurity control, and yield-improvement programs that enhance process economics and support robust commercial scale-up.

• Long-term technical partnerships that span clinical supply, validation, commercialisation, and lifecycle management.

From complex early-stage intermediates to commercially sensitive oncology APIs, we help innovators bring challenging molecules to market with confidence and continuity.