As a part of umbrella network of scientists, SYENZ covers vast variety of expertise in Pharmaceutical Processes, Manufacturing, and Compliance areas. The list of our expertise covers following:
- Oral Liquid and Semi-Solid/ Topical OTC Formulations.
- Pre-screening/Physical & Chemical Characterization Properties, Stability Evaluation studies.
- OTC Regulatory Consultation including Monograph, ANDA, NDA, and 505B Filing.
- cGMP Consultation for Manufacturing and Analytical Laboratory Setup according to FDA, ICH, and WHO Guidelines.
- Process Engineering including Manufacturing/Analytical Labs Designs supported by Time and Motion Studies. Operational Simulation, Equipment Selection, OSHA and NIOSH Standards Compliance.
- Quality Engineering, TQM, Process Capability Studies, Six Sigma Tolerances, QbD, DOE, and Artificial Intelligence/ Fuzzy Logic, ANN Application.
- Validation: IQ/OQ/PQ, Process and Cleaning Validation for Oral solid dose (Tableting, Encapsulation, Granulation)/ Parenteral / Bio-reactors/ Fermenters, Autoclaves, and Washers. Class II to V HVAC Validation including Protocols, Execution, Final Reports, Filters Validation, Air Changes Study, and Thermal Logging.