Pharma Analytical Labs companies specialize in providing critical wing and analytical services to the pharmaceutical industry. These labs play a pivotal role in ensuring the safety, efficacy, and quality of pharmaceutical products throughout their lifecycle from development and manufacturing to release and post-market surveillance. Their primary functions including raw materials, intermediates, and finished dosage forms to comply with regulatory standards and ensure adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
As pharmaceutical companies expand globally, their analytical labs must ensure compliance with international standards and regulations. Regulatory support includes understanding the requirements of various markets and helping labs navigate these challenges.
- FDA (U.S.) Compliance: In the U.S., regulatory support ensures that laboratories meet the requirements of the FDA, including compliance with 21 CFR Part 58 (GLP) and 21 CFR Part 211 (GMP for finished pharmaceuticals).
- EMA (EU) Compliance: For labs testing products intended for the European market, regulatory support ensures compliance with the EU’s GMP guidelines and the European Medicines Agency (EMA) regulations.
- Health Canada and TGA (Australia): Laboratories must also comply with local regulations in Canada and Australia, which may include submission requirements and quality testing standards specific to these regions.
Masuu can help analytical labs develop and implement GLP-compliant systems, including laboratory practices, documentation, and quality control procedures, to meet regulatory requirements. Ensuring that testing facilities maintain proper audit trails, traceability, and data integrity. Ensuring that pharmaceutical analytical labs comply with Good Laboratory Practices (GLP), which are guidelines established by the FDA and OECD to ensure the reliability and quality of laboratory testing.
Masuu Provide Regulatory support for pharmaceutical analytical laboratories for ensuring that laboratories meet global standards for safety, quality, and efficacy testing. This support spans compliance with regulatory guidelines, submission of required documentation, validation of testing methods, and ongoing quality control. By working with experienced regulatory professionals, pharmaceutical companies can ensure that their analytical laboratories are fully compliant and capable of generating high-quality data that supports product development, approval, and post-market surveillance.