As pharmaceutical, food and FMCG processing and packaging consultants, our biggest aim is to comply with the regulatory standards of the industry that our clients are in, while offering cost effective solutions. Having marketed and distributed products compliant to the various regulatory bodies, our team has gained vast experience with regards to regulatory knowledge and requirements, and we are thus in a well-equipped position to provide mock audits or third-party audits for facilities seeking various regulatory compliances.
Control of raw materials, both Active Pharmaceutical Ingredients (APIs) and Inactive Pharmaceutical Ingredients (IPIs or excipients), is a critical factor in any pharmaceutical manufacturing facility. The types of laboratory testing and the management of the testing methods and specifications is of utmost importance to ensure regulatory compliance is achieved and a quality product is consistently manufactured. All testing methods should be verified or validated by the site, to allow for full testing of any materials if ever required.
- Specification and method evaluation for raw materials and finished products
- Trouble shooting of problematic methods
- Analytical method transfers, including protocols and reports
- Method verifications and validations