Process Development for APIs, NCEs, KSMs & Oncology Molecules

We specialize in designing and optimizing scalable, compliant, and commercially viable synthetic processes for a wide range of molecules, including APIs, New Chemical Entities (NCEs), Key Starting Materials (KSMs), and oncology intermediates.

Our development expertise includes:

• Innovative & Cost-Efficient Chemistry
  Development of novel and patent-free synthesis routes, with a focus on efficiency, yield improvement, impurity control, and overall process robustness. We strive to deliver competitive and sustainable manufacturing pathways.

• Polymorph & Salt Form Optimization
  Evaluation and development of multiple polymorphs, salt forms, and solvates to meet target product profiles, regulatory expectations, and specific customer requirements. Tailored solutions ensure optimal stability, solubility, and performance characteristics.

• Seamless Technology Transfer & CMC Support
  End-to-end process development with smooth technology transfer to partner facilities or customer sites. We provide demonstration batches, scale-up support, and comprehensive CMC documentation packages to facilitate regulatory submissions and commercial readiness.

Our scientific rigor, regulatory understanding, and focus on operational feasibility ensure that every process is optimized for quality, scalability, and cost efficiency — delivering value from lab to commercial scale.

CDMO & API Project Execution

We offer comprehensive contract development and manufacturing services covering the full lifecycle of API and KSM projects : from early development to commercial supply — supported by robust regulatory and documentation practices.

End-to-End Development & Supply

• Contract development, scale-up, and commercial manufacturing

• Reliable product supply with full regulatory and quality compliance

• Execution through qualified and audited facilities aligned with global guidelines (USFDA, EDQM, WHO-GMP, etc.)

Regulatory Documentation & Technical Support

• Complete development documentation and technology transfer packages

• Preparation and submission support for DMFs, technical dossiers, and regulatory filings

• Ongoing CMC documentation and lifecycle management

Flexible Supply & Launch Support

• API and KSM manufacturing executed through approved contract facilities

• Initial commercial supply from partner sites for the first 1–2 years, with certifications and audit readiness

• Smooth transition to customer-owned or alternate facilities if required

Our collaborative model ensures quality, regulatory confidence, assured supply, and seamless technology transfer : supporting customers through every stage from concept to commercialization.

Business Development Across Domestic & ROW Markets

Extensive experience in driving business development initiatives across domestic and Rest-of-World (ROW) markets. Skilled in identifying commercial opportunities, establishing strategic partnerships, and accelerating revenue growth across emerging and semi-regulated markets. Proven capability in navigating procurement cycles, regulatory pathways, and customer expectations to build sustainable long-term relationships.

Specialized Focus on Europe & USA Regulated Markets

Strong expertise in developing and managing business across highly regulated geographies such as Europe and the United States. Familiar with advanced compliance requirements, quality frameworks, and commercial expectations in these regions. Successfully engaged with global pharmaceutical companies, innovator firms, and generics players to support tech transfers, supply agreements, and long-term collaboration models.

Flexible Manufacturing Scale: From Development to Commercial

Capability to support projects from early development to full-scale commercial supply, offering flexibility from gram-level R&D quantities to multi-ton batch production. Strong understanding of scale-up dynamics, pilot trials, process optimization, and commercial manufacturing strategies to ensure timely and cost-efficient delivery across various project stages.

Regulatory-Compliant & Globally Accepted Manufacturing Network

Commercial supply from world-class manufacturing partners complying with international regulatory standards, including WHO-GMP, EDQM, and USFDA requirements. Experience working with facilities adhering to global audit norms and equipped for API manufacturing, advanced intermediates, and specialty chemical synthesis. Ability to support customers with high-quality documentation, regulatory filings, and seamless supply chain execution for global market entry.

CMC Support