The products regulatory solicitors at RT Coopers are experts in product regulatory law. Our regulatory lawyers advise and assist companies researching, developing, manufacturing, supplying, distributing, labelling, packaging and advertising products on gaining the requisite licences and regulatory compliance.
Our pharmaceutical lawyers advise and assist International and UK pharma and biotech companies to obtain:the requisite authorisations and licences for the manufacture/importation of licensed medicinal productsandherbal medicines by ensuring the medicinal products meet the appropriate standards of safety, quality, efficacy and risk management laid down by the Medicines and Healthcare products Regulatory Agency (MHRA). Our pharma and biotech solicitors advise and assist pharmaceuticals, biotechs, life sciences companies in wholesale distribution to secure licences for the wholesale distribution/importation of medicinal products.
For companies requiring advice on dossiers to obtain marketing authorisations for medicinal products, biotechnology products and drugs, our scientific experts and pharma solicitors will advise and assist your company before submitting the dossiers to the MHRA.
Our regulatory solicitors will provide your company with the necessary advice and assistance to obtain the licences for the wholesale distribution/importation of medicinal products.
Our food lawyers also advise on consumer products as well as borderline borderline products such as cosmetics, foods and food supplements.
Our biocidal lawyers will advise and assist your company on the evaluation of your products, to obatin approval and authorisation and registration including advice on dossier and in obtaining authorisation and registration for their biocidal productsunder the Biocidal Regulation from the Health and Safety Executive (HSE). We advise clients in relation to REACH regarding the registration, evaluation, authorisation and restriction of chemicals they are importing, supplying and/or marketing.
With regards to achieving compliance in a specific country, we work with our associates that are situated globally, to ensure compliance in that country.
Our Services
Some examples of our expertise in product regulation include:
'The firm helped us through a scientific and regulatory issue raised by the HSE and we were poorly equipped to respond to the authority, prior to your firm’s efforts. Our overall impression of RT Coopers is that the firm is professional. The biocidal lawyers conducted a conscientious review of our issues and we got precise responses which we needed. The legal commentary on our issues helped us to respond to the authorities with confidence. The Report prepared by the firm was extremely detailed and enabled us to respond to the HSE where their follow up questions were minimal'. Sean-Robbie Campbell, Chief Executive Officer, Advanced Formulations (Europe) Ltd
Ice Healthcare Ltd
'RT Coopers Solicitors operate in the real world and deliver what they say they’ll deliver. A highly responsive, straight talking, client focused team who will pull out all the stops to deliver on-time results of the highest standard. Definitely a team you want along side you when the going gets tough. I think that says it all…' Janet Dean, Operations Director,