Pharmafind can provide local regulatory consultants in specific European countries who can offer insight into their local requirements. We can help when seeking Scientific Advice from European key opinion leaders or with preparing and attending Health Authority meetings e.g. presubmission, submission, hearings or appeals. We offer assistance on interpreting European guidelines and on clarifying the methods used for licensing pharmaceuticals in Europe eg, the Centralised, Mutual Recognition and Decentralised procedures. Our team are hard working, creative and accomplished and their remit is to offer tips and solutions to maximise the chances of you reaching your regulatory goals.
Pharmafind are efficient and well organised at reviewing proposed European regulatory filing strategies and/or creating new strategies for clients. We have a flair for suggesting improvements within the context of the European regulatory framework. We also have the added benefit of having local representatives and can therefore offer local regulatory intelligence as required. Alternatively, if you wish to acquire a product or company our team are very effective and methodical at reviewing data for due diligence/ gap analysis projects and we can do so in an independent but proactive manner. We are happy to travel to do so, as required.
Unlike some larger organisations, Pharmafind use European consultants that are known to us. We are therefore confident both in their willingness to get the job done on time as well as in their ability to do it correctly. Our consultants love to work as part of their clients’ team and to work with them through the often complex route to regulatory approval in Europe. Our consultants are happy to travel to our clients’ premises, to work remotely or to do a mixture of both, as preferred. Our reputation is based on our ability to deliver and we value our reputation.
At Pharmafind our specialists can work with you to develop a robust European regulatory programme. Alternatively, they can do an independent review of your company’s proposed plans to maximise your chances of gaining European approval in the shortest timeframe. They are practiced at critiquing plans and can see yours in the context of many others and within the structure of the European legislation. They are skilled at making recommendations in a proactive but positive manner. We can propose Key Opinion Leaders with whom to discuss your plans, as well as arrange scientific advice meetings with the European Regulatory Agencies. Our regulatory experts are also adept at working with clients to author, review and sign clinical, non clinical and CMC (Chemistry, Manufacturing and Controls) documentation, accordingly we offer gap analysis and due diligence services.
At Pharmafind we know that our people are key to our continued success, we only use the best. Our regulatory consultants have a proven track record for delivering on schedule for clients. We can support you with the preparation of regulatory documentation e.g. Paediatric Investigation Plans (PIPs) and annual reports, post authorisation safety studies, briefing packs for European regulatory authorities, response to questions documents, as well as maintaining licences via renewals and variations. We also have a proficiency in and enjoy compliance checking of marketing materials. Our consultants have built up good working relationships with the European regulatory authorities and are very keen to maintain and nurture these professional relationships. Almost all of our consultants have a minimum of 10 years experience of working within the regulatory profession.
Pharmafind has a large team of European regulatory experts located across Europe. Therefore, we can build perfectly tailored training courses to meet your requirements. If you are looking for guidance on a specific aspect of European Regulatory Affairs e.g. if you would like detailed information about the European regulatory procedures or if you have an interest in a specific formulation, therapy area or European country or if you have a particular niche area where you require assistance e.g. biotechnology, medical devices, orphan drugs, Paediatric Investigational Plans (PIPs) etc. we will choose our most appropriate consultants and tailor your training specifically to meet with your requirements. We are happy to present our training via video link or should you prefer, we are happy to travel to you to deliver your training. Please just contact us to discuss your specific needs.
‘I worked with Niamh Lawler-Turner whilst she was both Regulatory Affairs Advisor and Business Development Director at Life Scientific. During my time there I found her to be very driven with a clear focus at all times on the goal. This coupled with a wonderful personality and open approach ensured numerous successes for Niamh. I would recommend Niamh to any future client/business partner’.
Scientific Director at Contract Research Company, Ireland.
‘I have worked with Niamh on the Board of TOPRA for some years. She has many fine qualities and has been an excellent Board member. I found her both responsive to the needs of members and focused in approach. In everything she does she maintains a high level of enthusiasm and is a real team player. It has been a pleasure working with her and I would recommend her as a trusted and conscientious colleague’.
Independent Pharmco-legal Advisor, United Kingdom.
‘Niamh is very committed to her work and puts all her energy and enthusiasm into any project. She is extremely hard working and has a great personality too which provides a dynamic combination and allows her to succeed in anything she puts her mind to. It's always great working with her’.
Pharmacist / final signatory, Multinational Pharmaceutical Company, United Kingdom.