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UK Regulatory Services
Welcome to Satori OCS's comprehensive UK MHRA Regulatory, Registration, and Licensing Services. Our range of services is tailored to guide you through the intricacies of the UK Medicines and Healthcare products Regulatory Agency (MHRA) regulations, in ensuring compliance and successful market entry.
About MHRA (Medicines and Healthcare products Regulatory Agency)
MHRA is the national regulatory authority for medicines, medical devices, and blood components in the United Kingdom. The MHRA is responsible for ensuring that all medicines and medical devices in the UK meet appropriate standards of safety, quality, and efficacy, and for monitoring their safety once they are on the market.
The main functions of the MHRA include:
- Approval and licensing of medicines and medical devices before they can be marketed in the UK.
- Regulation and control of the manufacture, import, distribution, and sale of medicines and medical devices in the UK.
- Monitoring and surveillance of the safety and efficacy of medicines and medical devices in the UK, including the investigation of adverse reactions and side effects.
- Enforcement of regulations related to the labeling, packaging, and advertising of medicines and medical devices in the UK.
- Providing advice and guidance to healthcare professionals, patients, and the public on the safe and effective use of medicines and medical devices.
Divisions of MHRA
The MHRA comprises of various divisions that oversee different aspects of pharmaceuticals, medical devices, and healthcare products:
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Licensing Division
Responsible for granting licenses for drugs, medical devices, and healthcare products to ensure their safety and efficacy.
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Inspection and Enforcement Division
Conducts inspections to ensure compliance with MHRA regulations and takes necessary enforcement actions.
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Pharmacovigilance Division
Monitors and assesses the safety of drugs and medical devices in the market, ensuring timely reporting of adverse events.
Who Can Register
Various entities can register under the UK MHRA, including:
- Pharmaceutical manufacturers
- Importers and distributors of medicines and healthcare products
- Medical device manufacturers and distributors
- Cosmetics manufacturers and sellers
- Retailers and wholesalers of medicines and healthcare products
Categories of Regulatory Services
Our services encompass a wide spectrum of regulatory aspects within the UK's pharmaceutical and healthcare landscape:
- Drug Licensing
Obtain licenses for the sale, distribution, or manufacturing of pharmaceutical products in the UK. - Medical Device Registration
Navigate the complex process of registering medical devices and ensuring they meet MHRA regulations. - IVD Approval
Facilitate the approval process for In Vitro Diagnostic (IVD) devices, enabling their legal sale in the UK market. - Cosmetics Compliance
Ensure your cosmetic products adhere to the necessary safety and regulatory standards set by the MHRA. - Food Supplements Regulation
Ensure your cosmetic products adhere to the necessary safety and regulatory standards set by the MHRA. - Retailer and Wholesale Licensing
Acquire licenses necessary for the retail or wholesale distribution of medicines and healthcare products.
Our Services & Approach
Our expert team at Satori OCS offers a comprehensive suite of services to support your UK MHRA regulatory needs:
- Regulatory Consultation
We provide expert advice on MHRA regulations, helping you understand and navigate the intricacies of the UK regulatory landscape. Initiate a consultation with our experts to discuss your regulatory needs and understand the requirements. - Licensing Assistance
Our professionals guide you through the licensing application process, ensuring all necessary documents and requirements are met. - Documentation Preparation
We assist in preparing the required documents and compiling the required information, ensuring accuracy and completeness for a smooth application process. - Application Submission
We submit your application to the relevant MHRA division, ensuring accuracy and compliance. - Regulatory Compliance Support
Our team conducts thorough audits and provide ongoing support in ensuring that your products comply with MHRA regulations, reducing the risk of non-compliance issues.
Why Choose Satori OCS UK MHRA Regulatory Services
- In-Depth Expertise
Our team brings a deep understanding of MHRA regulations, ensuring accurate interpretation and implementation. - Tailored Solutions
We design customized strategies that address your specific product and industry requirements, leaving no compliance gaps. - Navigating Complexity
With Satori OCS as your partner, you can navigate the intricate web of MHRA regulations with confidence, minimizing risks. - Efficiency and Compliance
Our services expedite your MHRA compliance journey, ensuring timely market entry and ongoing success.
Choose Satori OCS as your reliable partner to guide you through the intricate UK MHRA regulatory landscape. Reach out to us today for a comprehensive consultation, and discover how our extensive expertise can effectively streamline your regulatory procedures, ensuring a seamless market entry and successful operations in the UK.
FAQs
Q1. How long does the Medicines and Healthcare Products Regulatory Agency (MHRA) drug approval process typically take?
The duration of the MHRA drug approval process can vary based on factors such as the type of drug and regulatory review time. It typically ranges from several months to over a year.
Q2. Can UK regulatory consultants assist with biosimilar approvals?
Yes, UK regulatory consultants can assist pharmaceutical companies in the preparation and submission of applications for biosimilar approvals, which is a specialized area within the pharma industry.
Q3. What are the post-market surveillance requirements for pharmaceuticals in the UK?
Companies must establish post-market surveillance systems to monitor the safety and efficacy of their products and report adverse events in accordance with UK regulations.