Our regulatory affairs consultants can help in all areas of international regulatory affairs relating to medicines, medical devices and other healthcare products in all the major territories of the world.
Our team of highly experienced regulatory affairs consultants can help with:
- Regulatory planning for a future submission
- Advice on international regulatory requirements
- Writing or reviewing a dossier
- Troubleshooting an unsuccessful submission or conducting an appeal
- Liaison with the regulatory authorities
- Maintenance of regulatory approvals throughout their life cycle
From early product development, our team of consultants can guide you to a regulatory pathway that will lead directly to a smooth and timely regulatory approval. Your scientific data can be assessed by discipline experts to identify and resolve any deficiencies and plan future studies. Formal strategic development plans can be drawn up and implemented. Furthermore, Wainwright Associates can provide global regulatory intelligence regarding local requirements for market entry in most of the major territories of the world, including emerging markets.
Meeting post-marketing pharmacovigilance, clinical study safety, or device vigilance obligations is a key requirement for most businesses. Wainwright Associates can help, whether it be the day-to-day handling of safety-related information on your behalf, providing consultancy for the safety aspects of your clinical trials/investigations, or conducting audits and training.
It is important to make sure all product literature has been user tested to confirm it is readily and accurately understood by patients. Leaflet testing is now a legal requirement for medicines in Europe. We offer several services in connection with product and patient information, including Summaries of Product Characteristics, labelling, PIL writing, user testing, artwork creation and preparation of versions for blind or partially sighted people.
Most companies at some stage enter into licensing negotiations with partners, whether for in- or out-licensing or for local manufacture, distribution or marketing. In these situations it is often convenient to contract out the ‘leg work' required to locate opportunities and judge the suitability of potential partners and/or products. In this way, clients are relieved of the task of ploughing through leads of which many may ultimately prove worthless, concentrating instead on the more positive opportunities that can be screened and short-listed by Wainwright Associates.
B2B Products and Services
Last Updated: 24-Jul-2012