Regulatory Compliance Audits Support Services
YOU will be sure that we will be getting the right help YOU need to carry out YOUR business Regulatory tasks
- GMP Compliance: Ensuring compliance with Good Manufacturing Practice (GMP) regulations, which dictate the quality standards for the manufacturing and testing of pharmaceutical products.
- Labeling and Packaging Compliance: Ensuring that drug labeling and packaging meet the necessary regulatory standards for accurate information and safety.
- Regulatory Reporting Compliance: Verifying compliance with requirements for reporting information to regulatory authorities, such as product changes
- Pharmacovigilance: Evaluating compliance with pharmacovigilance regulations, including the proper reporting and management of adverse events associated with pharmaceutical products.
- Pharmaceutical Storage and Distribution Compliance: Ensuring that pharmaceutical products are packaged, stored, and distributed in compliance with regulatory guidelines.
- Controlled Substances Compliance: Assessing compliance with regulations for handling and distributing controlled substances used in pharmaceutical products.
- Advertising and Promotion Compliance: Verifying compliance with regulations related to pharmaceutical product advertising and promotional materials to prevent misleading claims.
Our objective is to listen and understand YOUR business needs in order to provide YOU with the right regulatory solutions
Dr. Samer Sowidan