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hartered Pharma Consultants are proficient in various Pharmaceutical Quality and GMP regulations and training, including but not limited to:
- FDA 21 CFR Part 11, Part 210, and Part 211
- EU Guide to GMP (Volume 4)
- MHRA (Orange Guide)
- Health Canada (GUI-0001)
- PIC/S Guide to GMP for Medicinal Products
- ICH Quality Guidelines
- WHO
Trusted Compliance Experts
Chartered Pharma Consultants have been collaborating with pharmaceutical manufacturers and those in the supply chain for over 40 years. Our expertise encompasses reviewing Facilities, Equipment, Quality Management Systems, Computer Systems, Manufacturing and GMP processes to ensure compliance with regulatory standards. We support companies handling and producing pharmaceutical dosage formulations with defined therapeutic claims, including veterinary products, and active pharmaceutical ingredients. By partnering with Chartered Pharma Consultants, you gain access to consultants who routinely inspect facilities globally.
Comprehensive Training in Quality Assurance
Our consultants provide training to the people on quality assurance including data integrity, helping to enhance existing capabilities or new staff onboard. This knowledge is accessible through on-site and online, covering a wide range of topics in quality assurance and pharmaceutical product management/handling.
Excellence in Pharmaceutical Regulatory Consulting
Chartered Pharma Consultants has an unparalleled reputation for excellence in technical, regulatory consulting, and guidance services for the Pharmaceutical Industry, including generic and new drug products, OTC, monograph drugs, dietary supplements, and cosmetics. Chartered Pharma Consultants excel in the development, implementation, and management of diversified projects involving compliance such as regulatory inspection observations, scientific principles, technical aspects, and regulatory requirements related to pharmaceutical products.
Contact us to discuss your needs and discover how Chartered Pharma Consultants’ extensive expertise can benefit you.
Email : info@charteredpharmaconsultants.com
Phone: +353 1 564 3967