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| QUALITY
ASSURANCE Reliable QA advice and help Taking the fear out of regulatory inspections Quality management designed for your business Trusted outsourcing - contractor management Reducing the burden on your QP |
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| Quality and compliance is all about ensuring your business runs smoothly. This means taking the workload off the QP, reducing agency investigations and making sure your systems comply with regulations. There are many ways we can help achieve this. Reliable QA advice and help Many companies are looking to establish a presence in Europe to sell and distribute their pharmaceutical products. They often find it hard to get reliable advice and help to ensure a smooth rollout. This is where we come in. Our experts have over 20 years experience in the multinational arena. We'll help you set up the right quality systems covering the entire product lifecycle. This includes everything from product development and manufacture through to packaging, labelling and distribution. We help European companies import new products from outside the European Union. We'll explain what the regulators require and ensure you have acceptable systems in place. QPs can be provided to release products for manufacture. Taking the fear out of regulatory inspections Business owners often fear the inspection process. They worry their methods and procedures won't be acceptable to a regulator or potential investor. Our job is to take the fear out of the inspection process and ensure your procedures meet current standards and are the best they can be. Quality standards are more than just satisfying regulators, they add real value to your business and can prevent expensive delays and fewer adverse inspection findings. Quality standards expected by the regulatory authorities increase continually, and systems must be updated regularly. Quality systems must be seen as an investment for improving business and not just an expense. Working on your behalf, our experts will work with you to obtain the best outcome to any regulatory inspection. We'll examine: • Your manufacturing processes and submitted data • GMP review of manufacturing facilities and quality management systems • Work with in-house QA experts to improve presentation of facility and systems for investigator • Prepare response documents or appeals on your behalf • Work with you and represent you at oral hearings Quality management designed for your business Every business is different and requires quality systems that work best for them. We'll assess your needs and create a quality management system that suits your operation. We will assist you in meeting compliance with cGMP, ISO9000 and latest quality systems as appropriate. Trusted outsourcing - contractor management We retain complete independence and accept no fees from any contractors. Successful contractor management is about establishing good relationships with people involved. We have good working relationships with people at all levels in many key UK and European contractors. We carefully select contractors and people with the right skills and experience for each stage of your project, such as product development, manufacturing and packaging processes. We conduct routine contractor GMP reviews, and in-depth audits for specific projects, covering facilities, quality systems, manufacturing, packaging and analytical operations for small molecules and biotechnology products. Reducing the burden on your QP Regulations are essential to maintaining high standards, but they also create plenty of administration. Inspectors expect to see details of active ingredients, and complete chains of manufacturing authorizations, supply contracts and technical agreements. We'll reduce the burden on your QP by taking care of routine management and providing a series of reports to say each stage in your supply chain meets regulatory requirements. |
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| © 2008 Pharmaceutical Development
Services Limited. All Rights Reserved. Pharmaceutical Development Services Limited The Surrey Technology Centre, 40 Occam Road, The Surrey Research Park Guildford, Surrey GU2 7YG, UK Tel +44 1483 685420, Fax: +44 1483 685421 Registered in England and Wales, Number 4476828 VAT registration number 761 1430 60 |
