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REGULATORY AFFAIRS |
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| Establishing a European presence is a big undertaking and requires expert advice and careful planning. Our regulatory team will guide you through the legal and regulatory minefield and ensure a clear path to market. So what does this involve? Our work includes: • Regulatory support for pharmaceutical development services including manufacturing, analytical chemistry, formulation development, microbiology, biotechnology and clinical research • Development, preparation and assembly of complete dossiers for Europe and USA • Preparation of responses to regulatory authorities, comment letters, and assessment reports • Representation to regulatory agencies and meeting planning • Regulatory submission critique including recommendations to help improve review of applications by regulatory authorities • Assistance in responding to compliance issues • Accurate labelling • Due diligence on product regulatory packages • Dossier submission to regulatory authorities Practical advice and help We can provide advice on product formulation, indications and dosage instructions. We'll resolve issues around products with specific difficulties. For novel forms of therapy, we'll represent your company. We'll meet with regulatory agencies to discuss key concerns and report back on best course of action. Regulatory due diligence Regulatory due diligence can be undertaken for potential licensing opportunities. Our team will help you with chemistry and manufacturing as well as preclinical and clinical assignments. Helping to resolve regulatory questions Regulatory consultants act as a linchpin between many groups of people. From drug development teams through to marketing and legal affairs, as well as external health authorities. This holistic view of the drug development process means we're well equipped to respond to questions raised by regulatory agencies. We'll review questions raised and examine all submitted data. We will work with agency on your behalf to achieve a successful outcome. Document preparation Work begins as soon as a new drug is discovered and continues long after product reaches pharmacy shelves. Stringent testing requirements have to be met and include accurate and detailed information along with convincing analysis and results. Before documentation is submitted, it's down to regulatory affairs to ensure the right tests have been done at the right times - and with the correct interpretation of results. Even when a licence to sell a new treatment has been granted, work doesn't end there. It's important to ensure a medicine's packaging is accurate and informs patient about benefits and potential drawbacks. We'll manage implementation of responsible labelling and packaging to ensure new treatments are effective, have minimal risks and quickly reach your market. Good labelling can safeguard against drug misuse and prevent dangerous side effects. Accurate labelling can be as much a lifesaver as the drug itself. We'll prepare the following documents on behalf of our clients: • Mutual Recognition response documents • Briefing documents for pre-NDA or EMEA scientific meetings • Expert reports: CTD pharmaceutical, preclinical or clinical overviews. Acuo Dossier - the secure and user-friendly way to compile regulatory submissions Acuo Dossier is designed to enable rapid compilation of regulatory information required within each CTD module. It automates tasks and processes within the compilation and management process. Manual data entry is minimised, leaving your regulatory professionals to apply their skills to more important areas. 'Drag and drop' along with 'search and retrieve' tools enhance eCTD management during compilation. Post-submissions, updates and regulatory body requests are easily handled. These factors ensure Acuo Dossier will significantly reduce your CTD compilation time and costs. It's also kind to the environment by reducing volumes of wasteful paper. Acuo Dossier is a joint venture product of PDS and Point Solutions. |
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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 |
