561-972-7583

430 Toney Penna Dr.
Unit # 6
Jupiter, FL 33458
www.chiralanalytics.com

Revising, finalizing and scaling up formulation, Methods development, Methods validation... and more services we can provide.

Pharmaceutical Manufacturing Services & Support

  • Identify and qualify vendors for raw materials and API
  • Establish criteria for vendors as well as raw materials and API
  • Regulatory services such as: Establish specifications for API, SOPs, protocols etc. Keep records according to GMP requirements
  • Develop and validate methods for API
  • Develop and validate methods for cleaning reactor, surface etc.
  • State of the art instruments, routinely calibrated and certified according to GMP, well maintained and secured documents and audited by regulatory auditor/consultant
  • Accelerated stability studies: e.g. 40 °C/75% RH (6 months)
  • Long term stability study: e.g. 25 ° C/60% RH (12 months)
  • Photo stability study: Under UV light at 25 ° C (7 days)
  • Develop appropriate analytical method (s) for analysis after each sample time pool of sample
  • Prepare protocols for study including method of analysis, follow the protocol, record results and provide complete report with raw data and results in a timely manner
  • Effective communications, fast and reliable data in a timely manner that will save you time in manufacturing your products that will lead to faster production with confidence in analytical and regulatory issues