Our Services
Discover our comprehensive services tailored to accelerate your research, development, and compliance processes effectively.
ESTABLISHING LABS AND QUALITY MANAGEMENT SYSTEM
Converting a building into a compliant research laboratory is complex and time-consuming. Our team can help establish compliant R&D lab, QC laboratories, or small-scale manufacturing facilities, considering quality and regulatory requirements, at a reasonable cost.
We assist in setting up comprehensive QMS for R&D facilities (new/existing) compliant with GDP, GLP, or GMP. Our support includes gap analysis, risk assessment, audit readiness, and crafting quality documentation like SOPs, forms, test methods, protocols, and operational processes. Our team can conduct virtual or on-site quality audits and training sessions.
STRATEGIC PLANNING FOR DRUG DISCOVERY AND DEVELOPMENT
Early drug discovery is crucial for effective drug development. The initial experiments lay a strong foundation for the entire process. Our team can expedite your discovery journey towards potential therapeutics by offering continuous support in your discovery journey with focus on lead optimization, understanding the mechanism of action, in-vitro in-vivo pharmacology, formulation and product development.
A successful drug development journey includes understanding and meeting regulatory and quality standards. Our collaborative efforts can expedite your journey by providing support in robust product, formulation and process development, Pre-clinical studies and toxicology assessments, Process scale-up, technology transfer and validations, IND Application, CRO/CDMO collaborations for successful clinical trials, data-driven strategic guidance throughout the process, preparation and review of regulatory and quality documentation and complete project management services tailored to client requirements with cost efficient planning and faster timelines.
ASSAY DEVELOPMENT AND VALIDATION
Analytical assays form the core of drug development process, enhancing confidence by offering greater accuracy and precision throughout the process and even after market approval. Our team specializes in identifying and implementing the necessary assays essential for development of higher-quality and safer therapies within regulations.
We offer services for technical solutions and trouble shooting and training for assay development, qualification and validation, in-vitro, ex-vivo and in-vivo assays, CMC and characterization, assistance in improving assay outcomes to meet regulations for accuracy, precision and robustness allowing it use throughout the life cycle management of the molecule, preparing/reviewing documentations for assays and instruments, data driven assistance in defining critical quality parameters to meet regulatory expectations.
Project Management
Proficiency in project management plays a crucial role in steering the drug development journey in the right direction.
It has the potential to markedly enhance the overall cost, efficiency, and timeline of the outcomes.
With extensive experience handling numerous development projects, our team comprehensively grasps the essential elements of managing such endeavors. We are well-positioned to provide – Complete project management services, Services tailored to client requirements with cost efficient planning and faster timelines, Scientific, regulatory and quality guidance to accelerate the process, Management of external contracts and documentations, Coordinate meetings, activities and communication across different functional areas, risk management, Data driven strategic guidance throughout the process.