Outsourcing
A Pharmaceutical dosage form contract Manufacturing Third Party/ Loan Licence facilitation through qualified Reputed Pharmaceutical Manufactures and Pharma companies to cut costs, speed up development, access expertise, and scale flexibly while focusing on core innovation.
Regulatory Documentations
Essential dossiers like CTDs, INDs, NDAs, etc.. Submitted to Regulatory Authorities CDSCO and Application forms like Form 19, Form 24, Form 27 for sale / Manufacturing, Licensing douments, Guidance Documents, Coordinated between Central (CDSCO) and State Licening Autorities.
Clinical Trials Assistants
A pharmaceutical Clinical Research Assistants, Supports Clinical trials, handling essential paper work, data entry, Site Co-ordination and ensuring adherence to protocols (PHASE-4) and also PMS-Post Market Survelliane, BABE Studies for Regulatory filling.
Stability Studies Services Outsourcing
Helps Manage the crucial process of Testing drug Shelf-Life, involving Sample management, Data review of COA, Documentation (SOPs/Report) Co-ordinating with QA/QC/Manufacturing and ensuring compliance with GMP, often focusing on Scheduling, tracking and ensuring quality records for stability trials of new and existing Pharmaceutical products.
Analytical Method Development
We involve in Developing, Optimizing and Validating testing methods for Pharmaceutical products to ensure their Safety, Quality and Efficacy. Improve the efficiency and quality of your bioanalytical studies and increase throughput. Ensure data integrity and traceability in real-time for immediate correction.
Regulatory Services
In Regulatory Affairs, we help Drug Companies ensure their products to meet Regulatory Authority rules for Development, Manufacturing, Marketing and Handling the Crucial tasks like Preparing, Submission Documents and Managing Compliance with Regulators.
Formulation Development
Helps to Create final Drug products by supporting research, Pharmaceutical stability Testing Services and solid dosage - Drug Formulation Development Services like Drug-Excipients Compatability Studies, working in fast-paced R&D on Manufacturing Environment.
Clinical Research Solutions
We provide end-to-end Services, often through Contract Research Organisations (CROs) to manage and execute clinical trials for new drug/devices, and Pre-clinical Services for identified Head Molecules Analytical method, validation services, Pre-clinical and Toxicology Testing Services.
Compliance Services
We help Drug Companies follow Complex health, regulations for Safety and Market access, covering GMP, Quality Systems, Audits, Pharmacovigilance, Labelling and Documentation by ensuring products to Safe, Effective and Legally sound from development to Post-Market, reducing risks like fines and reputation damage.
