QA/QC
Ensuring Quality, Safety and Compliance across the Product Lifecycle
Anthem offers a full range of Quality Control (QC) and Quality Assurance (QA) services to ensure pharmaceutical products meet the highest standards of quality, compliance, and regulatory requirements. Our services span the entire product lifecycle, from development to commercialization.
Our Core Values: Precision Accuracy | Regulatory Compliance | Global Standards
Core Quality Control Offerings
1
Method Validation & Development
Specializing in analytical methods using HPLC, GC-MS, and LC-MS to ensure precision and accuracy in compliance with international guidelines.
2
API Release Testing
Rigorous testing for purity, content uniformity, and microbial safety, ensuring adherence to global pharmacopoeial standards.
3
Stability Studies
Comprehensive long-term and accelerated studies to assess physical, chemical, and microbiological stability under diverse conditions.
Separation Science & Microbiology
1
Chromatographic Techniques
Expertise in HPLC, UHPLC, and preparative HPLC for advanced impurity profiling and complex chiral separations.
2
Purification Support
Analytical support for process optimization to ensure the highest product purity during the manufacturing phase.
3
Microbiology Services
Equipped for sterility and bioburden testing within specialized laboratories to ensure total product safety.
Regulatory Affairs & Documentation
1
Global Filing Support
Assisting clients with the preparation and management of IND/IMPD applications, Drug Master Files (DMF), and e-CTD documents.
2
Standard Adherence
Ensuring total compliance with global regulatory standards including FDA, EMA, and ICH guidelines.
3
Agency Interaction
Expert support in responding to regulatory deficiencies and managing the review process with international health authorities.
Infrastructure & Modern Laboratories
1
Advanced Instrumentation
Laboratories equipped with the latest HPLC, UHPLC, GC-MS, and LC-MS instruments for high-precision testing.
2
Controlled Environments
Advanced stability chambers designed for testing under various specified temperature and humidity conditions.
3
GxP Excellence
Full GxP compliance for laboratory operations and cGMP-compliant facilities guaranteeing consistency at every stage.