Expertise & Skills

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:

  1. Oral Liquid and Semi-Solid/ Topical OTC Formulations.
  2. Pre-screening/Physical & Chemical Characterization Properties, Stability Evaluation studies.
  3. OTC Regulatory Consultation including Monograph, ANDA, NDA, and 505B Filing.
  4. cGMP Consultation for Manufacturing and Analytical Laboratory Setup according to FDA, ICH, and WHO Guidelines.
  5. Process Engineering including Manufacturing/Analytical Labs Designs supported by Time and Motion Studies. Operational Simulation, Equipment Selection, OSHA and NIOSH Standards Compliance.
  6. Quality Engineering, TQM, Process Capability Studies, Six Sigma Tolerances, QbD, DOE, and Artificial Intelligence/ Fuzzy Logic, ANN Application.
  7. 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.