NCE Development Solutions
At Shilpa Pharma, we are committed to supporting pharma and biotech companies in developing New Chemical Entities by providing end-to-end solutions across the entire drug development lifecycle while maintaining the highest standards of safety, quality, and efficiency.
Our expertise in route scouting, proof-of-concept studies, process research, risk assessment, and scale-up ensures that we deliver high-quality, scalable, and regulatory-compliant drug substances.
Route scouting
We specialize in identifying and developing the most efficient synthetic routes at the early stage of a program.
Our experienced scientists and process engineers focus on evaluating different pathways to optimize yield, purity, and cost-effectiveness. By conducting detailed feasibility studies, using phase-appropriate approach ensures that the chosen route aligns with the requirements of early-stage research, clinical trials, and commercial manufacturing.
Proof of Concept (POC) studies
Our POC studies validate the feasibility of the selected synthetic route and ensure smooth scale-up and regulatory acceptance. By conducting small-scale manufacturing, we supply initial batches swiftly to generate preliminary data from biological testing, stability evaluation, and toxicological studies to nominate a drug candidate.
Our team focuses on process robustness, ensuring that the selected route could be extrapolated to higher scales to meet the future demands and compliant with regulatory expectations. These investigations form the foundation for further process optimization and commercial scalability.
Process research and development
With our state-of-the-art facilities and experienced scientific teams, we focus on developing and optimizing robust manufacturing processes for NCEs.
Our development expertise includes route optimization, reaction parameter refinement, and impurity profiling, ensuring efficient and scalable synthesis. We implement Quality by Design (QbD) principles, identifying Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs) to ensure batch-to-batch consistency. Our integrated approach allows us to develop cost-effective, scalable, and regulatory-compliant manufacturing processes for clinical and commercial production.
Scale-up studies
Our scale-up capabilities safeguard a seamless transition from lab-scale synthesis to pilot-scale and full-scale manufacturing. We optimize processes for reproducibility, yield improvement, and cost efficiency, ensuring that the manufacturing process remains robust across different scales.
Our GMP facilities allow us to produce pilot-scale batches that are critical for regulatory submissions and commercial readiness. With a strong focus on process validation and technology transfer, we ensure that scale-up activities align with global regulatory requirements.
Risk Assessment
A robust risk assessment strategy, incorporating HAZOP and HAZAN, is embedded into every phase of NCE development to ensure process safety, regulatory compliance, and scalability. We systematically evaluate potential risks tied to raw materials, reaction conditions, thermal hazards, and impurity formation and mitigate process-related risks. Through the integration of HAZOP, we conduct detailed deviation analyses to uncover operational and safety risks, while HAZAN provides a quantitative assessment of hazard likelihood and severity.
By leveraging predictive risk assessment models, we ensure the development of safe, reproducible, and regulatory-compliant processes, aligning with global standards and minimizing risks throughout the product lifecycle.
Manufacturing Solutions
At Shilpa Pharma, we offer end-to-end contract development and manufacturing solutions, ensuring seamless progression from concept to commercial.
With over 35 years of expertise, state-of-the-art infrastructure, and a commitment to regulatory excellence, we provide high-quality, scalable, and compliant drug substance manufacturing services tailored to the evolving needs of the pharmaceutical industry.
Pre-Clinical Supply
At Shilpa Pharma, we support pharma, mid-pharma, biotech and Academia in accelerating early development by offering pre-clinical development and manufacturing. Our expertise in route scouting, feasibility studies, and small-scale nGMP & GMP production enable our partners to access early-stage material for toxicological studies and proof-of-concept evaluations.
Our scientific team focuses on optimizing synthetic routes and developing robust processes that ensure a smooth transition from concept to commercial. Our analytical capabilities complement this phase by providing method development and validation to ensure the reliability of early-stage data.
Clinical Supply
Our clinical supply manufacturing services ensure that drug candidates progress seamlessly across all clinical phases with high-quality, GMP compliant drug substances. We provide phase-appropriate drug substance manufacturing, ensuring scalability and regulatory compliance at every stage. With flexible manufacturing capabilities, we efficiently produce clinical trial materials in line with global regulatory requirements.
Our process optimization ensures that clinical batches are manufactured consistently, allowing for a streamlined transition to late-stage development and commercialization.
Process Validation
We specialize in manufacturing PV batches that are essential for regulatory submissions and commercial-scale readiness. Our expertise lies in process optimization, critical process parameter (CPP) identification, and batch consistency, ensuring the robustness of a manufacturing procedure at an appropriate batch size.
Our regulatory-driven approach ensures compliance with major regulatory bodies, including the USFDA, EMA, PMDA, MFDS, and other global health authorities, supporting seamless NDA and ANDA approvals. By ensuring scalability and reproducibility, we help pharmaceutical companies achieve smooth commercialization while maintaining high-quality standards.
CMC Support for IND & NDA Filings
Our Chemistry, Manufacturing & Controls services play a crucial role in enabling successful IND and NDA filings. We provide comprehensive CMC documentation, covering process development, analytical method validation, impurity profiling, and stability studies in accordance with ICH guidelines. Our regulatory experts ensure compliance with stringent global requirements, streamlining the approval process.
With a strong focus on data integrity and quality assurance, we support pharmaceutical companies in meeting regulatory expectations while advancing their drug development programs efficiently.
Commercial Manufacturing Services
At Shilpa Pharma, we offer large-scale commercial manufacturing services for a wide range of KSMs, RSMs, Intermediates, APIs (oncology and non-oncology), peptides, and specialty chemicals. Our state-of-the-art cGMP facilities are designed to meet the highest global regulatory standards, ensuring the consistent production of high-quality drug substances.
With a strong commitment to process efficiency and quality control, we ensure seamless commercial-scale production while maintaining compliance with USFDA, EMA, PMDA, MFDS, and other international regulatory agencies. Our expertise in HPAPI manufacturing, coupled with advanced containment technologies, makes us a preferred partner for global pharmaceutical companies seeking reliable and scalable manufacturing solutions.
Tech Transfer & Customized Supply Security Solutions
Ensuring a seamless technology transfer from development to commercial-scale manufacturing is a key aspect of our services. At Shilpa Pharma, we specialize in technology transfer strategies that ensure a smooth transition from R&D to full-scale production, minimizing risks and maintaining product quality.
Our customized supply security solutions ensure uninterrupted global drug availability, with a focus on strategic inventory management and risk mitigation. By integrating regulatory compliance, supply chain resilience, and process optimization, we help our partners achieve long-term sustainability and global market success.