Services
Advancing Pharmaceutical Excellence
Sushen delivers cutting-edge solutions across the pharmaceutical industry. From drug development and regulatory compliance to quality assurance and project management, our services are designed to meet the highest standards of business excellence and operational efficiency
Pharmaceutical Project Management Services
Sushen offers a critical understanding of global pharmaceutical requirements for the production and marketing of various formulations. Our services cover everything from the conceptualization and design of new plants to the setup of manufacturing facilities and their commissioning. Sushen’s expertise also includes the extension and expansion of existing plants, ensuring compliance with modern and regulatory standards. In short, we provide a complete turnkey solution for the pharmaceutical industry.
Designing Of Plant
(As per WHO-GMP / USFDA
/ UK MH-RA)
Our services span from site master planning and conceptualization to HVAC engineering, including equipment selection and comprehensive architectural design for robust medical facilities.
Equipment &Processing
We specialize in the procurement and setup of essential industrial machinery, supplying complete production gear, advanced HVAC systems, and high-quality cleanroom panels, with thorough and stringent qualification protocols.
Engineering Services
From inception to execution, we manage plant commissioning, conduct mock audits, perform gap analysis inspections, and create comprehensive SOP documentation.
Scale-Up Assistance
Our services include meticulous project design, precise equipment selection, rigorous scaleup studies, and thorough process validation for optimal outcomes.
Contract Development And Manufacturing Organization
Sushen provide CDMOs with customized development and manufacturing solutions, ensuring that specific product requirements are met while maintaining high standards in quality and compliance Dedicated facility for effervescent tablet from early-phase development and clinical trial production to commercial manufacturing and global distribution
Stability Studies Management
Sushen offer compliant sample storage,continuous parameter monitoring, timely retrieval and analysis, report generation,and rental storage facilities for seamless submissions.
Pre-Formulation
Studies
Sushen services include examining drug physiochemical properties, solubility, compatibility with excipients, method development and validation, and comprehensive stability studies.
Validation And Support Activities
Sushen Validation Master Plan (VMP) outlines protocols for DQ, IQ, OQ, PQ, system validation, with comprehensive reports and handson training support.
Formulation And Dosage
Sushen offers drug development services for various dosage forms, including tablets, capsules, and pellets, with both immediate and modified release formulations to meet therapeutic needs.
Clinical And Analytical Support
Sushen produces clinical trial batches and supports projects from formulation development to tech transfer. This section includes analytical development like method optimization and validation, crucial for drug development processes.
Regulatory And Microbiology
Sushen assists with BA/BE studies, regulatory dossier preparation (CTD/ANDA), and conducts microbiology studies, including endotoxin testing, to comply with safety and efficacy standards in pharmaceuticals.
Product Design & Development
Sushen specialize in oral dosage forms such as IR, MR, and CR tablets, dissolvable, sublingual, and various coated capsules and pellets. Our expertise ensures quality formulations tailored to specific needs.