Anders Associates have over 30 years planning & design experience in the development of engineering solutions for pharmaceutical manufacturing and research and development facilities.
Our multi-disciplinary consultants have experience in the documentation and implementation of validation of all types of facilities and equipment to satisfy the stringent demands of the FDA, EMEA, and all other international regulatory authorities.
Regulatory Compliance Advice
Anders Associates provides consultancy in all aspects of regulatory compliance. This is done by widely experienced consultants, including ‘Qualified Persons’ under EEC Directives 75/319/EEC and 81/851/EEC. We can provide specialist consultants to undertake: • GMP compliance audits for evaluation of facilities and processes prior to regulatory inspection. • Design and engineering auditing • Supplier auditing, as required by regulatory authorities • Development of Quality Assurance systems in existing facilities • Planning and implementation of Total Quality Management, Quality Assurance, and Quality Control systems for new facilities. • Consultancy and advice on implementation of ISO 9000 standards and accreditation.
System & Facilities Validation
For new and existing facilities, we can provide consultancy services in the preparation of Standard Operating Procedures (SOPs), protocol writing, and their implementation. Anders Associates can provide full validation services from the preparation of the user requirements specifications, writing the validation master plan and though the qualification stages of project implementation. We are also able to provide prospective, retrospective and routine validation studies as well as training for validation.