About Us

Q. Which industries do you work in?
A. We work in the pharmaceutical, biological, medical devices, herbal, cosmetics, food supplements, in vitro diagnostics, homoeopathic industries and are experts in advising on borderline considerations.

Q. Can we outsource part of our regulatory affair or pharmacovigilance?
A. Yes, we are happy to assist with as little or as much as you wish to outsource. We offer a flexible service that will cater to your needs.

Q. How long does the registration process take?
A. The registration process will vary dependent on the project. We will be happy to advise potential timescales when we conduct our initial consultation.

Q. Do you have eCTD capabilities?
A. Yes, high quality, professionally published submissions are now an expectation of all regulatory authorities and use of the eCTD is increasingly demanded.  At Wainwright Associates, we have a full in-house facility to ensure that the published output bears the high quality and user-friendly finish. This will help create the right impression and facilitate review throughout validation, assessment and approval.

Q. Can you help with finding a local manufacturer or distributor?
A. Yes, we will work to your requirements;  conduct searches, vet companies and arrange meetings. Through our network of local advisors, this service can be offered worldwide. 

Q. Do you have access to local advisors?
A. Yes, we work with local representatives in over 60 countries who have the knowledge and good contacts in their national authorities to help with any query you may have. All our advisors are independent and speak the local language and can not only help with local regulations in their country but also advise on current attitudes.

Q. Do you work in emerging markets?
Y. Yes, we can help with registrations, strategy development, providing local QPPVs and numerous other services to companies in emerging markets.

Q. Do you have translation capabilities?
A. Yes, English is the primary language we work in; however, we have partners in nearly all EEA member states who can provide translations in all languages.

Q. Can you source new licensing opportunities?
A. Yes, we can help with both in-licensing and out-licensing. Our consultants can begin with a search within our database of over 8000 licensing opportunities for generic medicines or conduct a proactive search for novel technologies. We will perform due diligence, assist with negotiations and then handle the transfer of ownership and technology.

Q. What training do you offer?
A. Our training and seminars services can be either dedicated one-to-one training sessions or customised seminars on any topic relating to regulatory affairs or pharmacovigilance. Please click here for more information on training and seminars.

Q. Can you train our staff in-house?
A. Yes, we offer in-house and offsite training as well as web-based approaches. We are happy to evaluate your training needs and offer a solution that will suit your situation.

Q. What training do you offer for non-European companies? 
A. For non-European companies wishing to be trained in regulatory affairs or pharamacovigilance, an option available is webinar training; a cost effective method of training employees in different countries. Employees can log-in and be trained at the same time using an easy to function web-based application.
We also offer residential and “hands-on” based training where employees can reside with a qualified TEFL teacher for an agreed period to help them to improve their English, as well as working on your company’s projects with one of our  consultant at our office on a daily basis.

Q. Do you offer web-based training?
A. Yes, webinar training is a cost effective method of training employees whether in different locations or in the same office. Employees can log-in and be trained at the same time using a web-based application. This alleviates any travelling time and costs associated with conducting a training session in-house (by the trainer) or out (by the employee).

Q. Are there local differences in medical practice that impact product development?
A. Yes, we can help advise and create a strategy which will take into account the differences in medical regulations and practices.

Q. How will we know what changes are expected in the coming years?
A. If you wish to be kept up to date, we can track your product lines and communicate to you any information related to them. We can also keep you up to date with any industry-related changes through our e-shots and news items on our website.

Q. Can you help us develop our regulatory strategy?
A. Yes, we will work with you and your team to ensure we put together a feasible clinical and regulatory development plan that both companies can work towards.  It is important to do this at an early stage in product development as the strategy determines the data requirement and ultimately the suitability for a marketing application.

Q. What happens if our strategy changes?
A. Having recommended a suitable clinical and regulatory strategy we can monitor and revisit this if any changes occur during product development. 

Q. How much notice is required prior to a project commencing?
A. This may vary; however, we recognise the urgency of many projects and are very used to responding at short notice.

Q. Is our information kept confidential?
A. Client confidentiality is taken very seriously at Wainwright Associates and we never discuss details of any projects with third parties without the express permission of our client. Not even the names of our clients are disclosed, nor the fact that we have been engaged by them. We are happy to sign a formal Confidentiality Agreement, either based on our template or your own.

Q. Do we need a Pharmacovigilance department?
A. No, but you do need to have someone to maintain and help meet your pharmacovigilance obligations.  Sponsors of clinical studies and holders of Marketing Authorisations for medicinal products are required continuously to monitor the safety of trial subjects and patients and meet ever more stringent regulatory requirements. In addition, the post-marketing surveillance and vigilance reporting requirements for medical devices have recently been formalised with the implementation of a more structured EU-wide vigilance system. We can help you – we have experts available to manage your company’s pharmacovigilance requirements or if you wish for this to be kept in house we can train a member of staff.

Q. Which countries do you cover?
A. We cover most of the major global territories involved in the development of pharmaceutical and healthcare products and many others, including emerging markets. Click here for a list of countries.

Q. Do I need a physical/legal presence in Europe?
A. For marketing authorisations and CE marks it is important to have legal representation in Europe. We can advise how to set up the appropriate representation. We can help companies to register for SME status, as well as help with orphan drug designation.

Q. Do you have access to clinical, toxicological, CMC and Pharmaceutical development experts?
A. Yes, we have a variety of available experts able to assist with  regulatory submissions, who will write and sign off  Non-Clinical and Clinical Overviews.

Q. Can you provide us with ad hoc assistance and advice if we have any urgent requirements?
A. Yes, we work in 15 minute intervals which enables us to be flexible. We can be available at short notice via telephone and email if the matter is urgent and we will always provide the most appropriate expert.

Q. Can you run clinical studies?
A. We do not run clinical studies ourselves, however we have a wealth of clinical expertise in out team which is available to guide companies on their clinical development, prepare clinical dossier components, write and sign clinical overview and underpin pharmacovigilance activities. If required we can also work closely with your chosen CRO or recommend a suitable clinical CRO.


If you would like to discuss a current or future project with one of our consultants, please contact us on +44 (0)1628 530554 or email enquiries@wainwrightassociates.co.uk.