We are leading product regulatory
Lawyers providing high quality legal
adive to companies in various sectors
Agrochemicals - Antibacterial Wipes - Antimicrobial Resistance - ,Antiviral Wipes - Beverages - Biocides - Biosimilars - CBD: Cannabidiol Products - Chemicals - Confectionery Products - Cosmetics - Disinfectants - Drugs - Electronic Cigarettes - Electronic Products - Food - Food Supplements - Herbal Medicines - Infant Food Products - Insecticides - Medical Devices - Medicinal Products - Nutraceuticals and Functional Foods - Pesticides - Plant Protection Prroducts - Preservatives - Textiles - Surgical Face Masks - Toys - Vaccines - Veterinary Hygiene Products - Veterinary Medicines
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 products and herbal 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 products under 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:
Medicinal Products,
CBD: Cannabidiol Products
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- Advice on Advanced Therapy Medicinal Products
- Advice on Dossiers
- Labelling and Packaging
- Marketing Authorisations
- Regulatory Data Protection
- Regulatory Compliance
- Renewal and Variation of Marketing Authorisations
- Legal and Regulatory Compliance
- Wholesale Distribution Authorisations
- Manufacturing Licences for Medicinal Products
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Biocides: Antibacterial Wipes, Disinfectants, Antiviral Wipes,
Pesticides |
- Advice on complying with the Biocidal Product Regulation and the requirements for obtaining Authorisation
- Preparation of Application for Approval and Authorisation under the Biocidal Product Regulation
- Product Evaluation
- Labelling and Packaging
- See our dedicated Biocidal Products and Treated Articles page
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REACH Chemicals
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- Advice in relation to REACH regarding the Registration, Evaluation, Authorisation and Restriction of Products being imported, supplied and/or marketed
- Authorisation and Registration
- Classification of Products
- Product Evaluation
- Labelling and Packing
- Regulatory Compliance
- See our dedicated Chemicals and Articles containing Chemicals page
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Cosmetics
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- Advice on Cosmetic Safety and Compliance
- Advice on meeting the requirements of the Cosmetic Products Regulation, UK Cosmetic Regulation
- Advising on Cosmetic Product Safety Reports and whether these comply with the requirements
- Product Evaluation
- Labelling and Packaging Compliance
- See our dedicated Cosmetics Law page
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Electronic Cigarettes
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- Advice on the requirements for obtaining Marketing Authorisations
- Preparation of Dossiers for Marketing Authorisations
- See our dedicated Electronic Cigarettes page
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Electronic Products
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- Advising on UK Law
- Advising on regulation of Electrical Equipment (WEEE and RoHS)
- Advising on intellectual property rights
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Food Law, Food Supplements, Infant Food Products
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Herbal Medicines
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- Advice on the classification of Herbal Medicines
- Advice on Regulatory issues concerning Traditional Herbal Medicine Registration and Marketing Authorisations for Herbal Medicinal Products
- Advice on Traditional Herbal Medicine Registration
- Preparation of Application for Traditional Herbal Medicine Registration
- Product Evaluation
- See our dedicated Herbal Medicine page
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Medical Devices
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- Advice on Advanced Therapy Medicinal Products
- Advice on Clinical Investigations
- Advice on Labelling of Medical Devices
- Advice on Medicinal Devices
- Quality and Regulatory Compliance
- Medical Devices page
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Surgical Face Masks and Surgical Gloves |
- Application for regulatory approval
- Preparation of Application for Regulatory Approval
- Classification of Products
- Covid19 Exemption
- Claims
- Conformity
- CE Marking
- Requirements for Labelling and Packaging
- Vigilance
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Textiles
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- Advising on UK and European regulations
- Advice in relation to REACH
- Regulatory advice, including substances of very high concern (SVHC), Restricted Substances List (RSL)
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Toys |
- Advice and assistance with the creation of a Technical File
- Advice in relation to CE Marking of Toys
- Advice in relation to Classification, Labelling and Packaging of Toys
- Advice in relation to Compliance with Safety Requirements
- Advice on Liability and Risk Assessment
- Advice on the Presentation and Advertising of Toys
- Declaration of Conformity
- REACH Chemicals
- See our dedicated Toys page
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Vaccines |
- Artificial Intelligence
- Clinical Trials of Vaccines
- Commercial Contracts & Corporate Finance
- Preclinical and/or Clinical Development of Vaccines
- R & D Agreements
- Advice on the Preparation of Registration Dossier for Vaccines
- Liaising with the MHRA for Approval of Vaccines
- Approval of Vaccines from the MHRA
- Evaluation of Clinical and Non clinical Data
- Intellectual Property
- Intellectual Property Protection in relation to the Patenting of Biosequences and Chemical Structures
- Licensing
- Manufacturing and Supply of Vaccines
- Marketing Authorisations
- Post Marketing Authorisation
- Regulatory Approval
- Preclinical Pharmacological and Toxicological Compliance
- Safety Compliance
- Vaccines page
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Veterinary Products
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- Advice and assistance with Wholesale Dealer’s Authorisations for Veterinary Medicines
- Advice and assistance on Appeals against Regulatory Decisions
- Advice and assistance with manufacture, authorisation, marketing, distribution and post-authorisation surveillance of veterinary medicines
- Compliance with UK Veterinary Regulations including the Veterinary Medicines Regulations
- Marketing Authorisations for Veterinary Medicinal Products
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Related Services
Articles
- Food Supplements: How to ensure Compliance of Food Supplements under UK Law, March 2021
- Online Pharmacies: Guidance for Registered Pharmacies providing Pharmacy Services at a Distance including on the Internet, June 2019
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Intellectual Property: Design and Trade Mark Law changes- no deal Brexit Guidance, April 2019
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Placing manufactured goods on the EU and UK internal markets-no deal Brexit guidance, March 2019
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Food Safety: Guidance on Food Traceability, Withdrawals and Recalls within the UK Food Industry, March 2019
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MHRA submissions if NO DEAL BREXIT guidance: Making submissions to the MHRA in a no deal scenario, March 2019
- Food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control, April 2015
- Food Labelling: Presentation and Advertising of Foodstuffs: Nutrition Labelling: Provision of Food Information to Consumers, October 2013
- Toys: How to Manufacture, Design and Supply Toys Safely - Compliance and Enforcement of Labelling and Packaging of Toys under the Law, September 2013
- New EU Biocidal Regulation: Treated Articles, August 2013
- Food Supplements (vitamins and minerals): How to ensure your Food Supplements are Compliant under the Law, July 2013
- Herbal Medicines: Traditional Herbal Registration, June 2013
- Are you ready for the Cosmetics Regulation? March 2013
Testimonials
Advanced Formulations (Europe) Ltd
'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,
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