Quality Assurance
Pharmaceutical-Grade Excellence in Polymer Engineering
GMP-Compliant Manufacturing
At SRDK, we adhere to the highest manufacturing standards to ensure every batch meets precise biomedical requirements.
Stringent Quality Control
Multi-stage QC protocols integrated into every step of the synthesis process, from raw material validation to final product release.
Batch Consistency
Precision-controlled polymerization kinetics ensure reproducible molecular weights, polydispersity, and monomer ratios across all production runs.
Comprehensive Testing
Every batch undergoes exhaustive testing for residual monomers, catalyst traces, and heavy metals to ensure absolute safety for pharmaceutical use.
Manufacturing Standards
- Controlled environment facilities (Class 10,000 / ISO 7 capable)
- Validated equipment with 21 CFR Part 11 compliant data systems
- Standard Operating Procedures (SOPs) for all critical operations
Regulatory Readiness
We provide the technical and regulatory foundation required for your clinical trials and commercial approvals.
FDA-Relevant Standards
Our polymers are synthesized following materials-use guidelines relevant to FDA, EMA, and other global regulatory bodies.
Client Filing Support
Assistance with IND, NDA, and ANDA filings, providing critical data for your Chemistry, Manufacturing, and Controls (CMC) section.
Full Documentation
Comprehensive documentation including Certificates of Analysis (CoA), Materials Safety Data Sheets (MSDS), and batch records.
ISO Certified
9001:2015 Standards
Data Integrity
Full Audit Trails
Advanced Analytical Capabilities
Our state-of-the-art laboratory is equipped to provide molecular-level confirmation of polymer structure and purity.
GPC / NMR Analysis
High-resolution Gel Permeation Chromatography for MW distribution and Nuclear Magnetic Resonance for chemical composition verification.
HPLC / Degradation Studies
High-Performance Liquid Chromatography for purity assessment and accelerated/real-time degradation studies to predict polymer behavior.
Purity Confirmation
Verification of residual monomer levels < 0.5% and catalyst traces to ensure the highest biocompatibility standards.
Analytical Toolkit
Ready for Production?
Contact our quality team for complete documentation, technical dossiers, and quality agreements.