UK Responsible Person
At 2Harris Consulting, we specialize in assisting non-UK manufacturers in navigating the complexities of UK life sciences and pharmaceutical regulations. As your designated UK Responsible Person, our profound expertise in UK and GB regulations ensures seamless compliance for your products. We understand the critical need for UKCA, UKNI, and CE markings as symbols of adherence to legislative standards. By registering your products with the MHRA and serving as your vigilance representative, we offer a comprehensive and responsive service tailored to uphold your product's compliance, allowing you to focus on innovation and growth in the global market.
Person Responsible for Regulatory Compliance (PRRC)
At our consultancy, we offer expert guidance as the Person Responsible for Regulatory Compliance, specializing in assisting companies that place medical devices and in vitro diagnostic devices (IVDs) in the UK and EU markets. Our focus is on ensuring that your products consistently adhere to the stringent CE marking requirements, a hallmark of regulatory compliance. Our detailed knowledge of EU regulations, combined with our proactive approach to regulatory challenges, guarantees that your medical devices and IVDs not only meet but exceed the necessary standards, safeguarding your market position and upholding the highest levels of safety and efficacy.
Qualified Person for Pharmacovigilance (QPPV)
As your Qualified Person for Pharmacovigilance, we provide specialized services essential for pharmaceutical companies operating in Europe. Our role is pivotal in ensuring compliance with post-market surveillance requirements, a critical aspect of maintaining product safety and efficacy in the dynamic European pharmaceutical market. We employ a rigorous, detail-oriented approach to monitoring, evaluation, and reporting of safety data, enabling your business to respond swiftly and effectively to any emerging safety concerns. Our expertise in this domain not only ensures regulatory adherence but also fortifies your commitment to patient safety and continued trust in your products.
Regulatory
Pharmaceuticals
At 2Harris Consulting, we specialize in creating robust regulatory strategies and solutions for new drug applications and amendments in the pharmaceutical industry. Our expertise extends to collaborating with global regulatory agencies, understanding the intricacies of the pharmaceutical market, and successfully supporting drug applications across the US, Canada, EU, UK, Brazil, China, Australia, and New Zealand. We pride ourselves on our comprehensive knowledge in pharmacovigilance and offer our services as your Qualified Person for Pharmacovigilance (QPPV), ensuring your business meets all regulatory requirements with efficiency and precision.
Medical Devices
Navigating the regulatory pathway for medical devices, whether entering new markets or launching new products, demands expert guidance. 2Harris Consulting offers extensive regulatory support, providing a tailored market access roadmap for companies looking to expand their reach. Our global expertise encompasses a thorough understanding of regulatory, quality system, and clinical requirements, ensuring a smooth registration process and ongoing compliance. We stand ready to assist you in overcoming any regulatory challenges, securing your product's success in the global market.
IVD and Companion Diagnostics
In the rapidly evolving field of IVD and companion diagnostics, 2Harris Consulting delivers specialist services for market expansion and new product launches. We assist in planning, development, registration, and launch, focusing on key geographical locations with unique regulatory pathways. Our in-depth knowledge and experience in these markets make us an ideal partner to facilitate this complex process, supporting our clients in achieving successful market entry and sustained compliance.
Due Diligence
At 2Harris Consulting, we excel in conducting comprehensive due diligence tailored to the dynamic requirements of the global medical and pharmaceutical industries. Our services extend beyond assisting clients in entering new markets; we ensure that once approvals are obtained, companies maintain unwavering regulatory compliance. Specializing in Regulatory and Quality (GMP) compliance, our expertise spans the Medical Device, Pharmaceutical, IVD, and Biologics sectors, aligning with global legal standards. We provide our clients with the assurance and guidance needed to navigate the complexities of the global economy while upholding the highest levels of regulatory.
Technical Services
Statistical Services
2Harris Consulting stands as a trusted partner in the Life Sciences and Pharmaceutical sectors, offering an extensive suite of clinical consulting services with a focus on Biostatistical excellence. Our expertise encompasses the entire spectrum of clinical research design, aimed at substantiating your marketing claims, optimizing clinical trial experimental designs, and expanding post-launch marketing claims. We excel in areas such as reimbursement justification, healthcare economics, and regulatory application support. Our services include comprehensive clinical statistical analysis plans, clinical study design, sample size planning, and marketing statistical support, ensuring that every aspect of your clinical research is underpinned by robust and precise statistical methodologies.
Technical Writing
In the realm of technical writing, 2Harris Consulting provides top-tier services encompassing detailed literature reviews, clinical evaluation reports, and evidence-based reviews. Our expertise in crafting these critical documents ensures that they are not only comprehensive and in-depth but also clear and concise, facilitating informed decision-making. Whether it's a literature review that offers a thorough analysis of existing research, a clinical evaluation report that synthesizes clinical data and findings, or an evidence-based review that critically assesses available information, our technical writing services are designed to support your organization's needs in presenting precise, evidence-backed information in a professional and accessible manner.