Summary
- Profile Type
- Business Offer
- POD Reference
- BOGB20241104013
- Term of Validity
- 12 May 2025 - 12 May 2026
- Company's Country
- United Kingdom
- Type of partnership
- Commercial agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- The UK based company seeks a commercial partnership to overseas companies that need assistanc in navigating the complex regulatory processes required for product development, approval, and marketing on a global scale. This includes ensuring compliance with regulatory agencies such as the FDA in the U.S o EMA in Europe. In addition to regulatory support, they offer expertise in setting up quality management systems, ensuring that companies meet industry standards like GMP and ISO standars
- Full Description
-
With over twenty years of experience,the British company channels its expertise into identify and bridge the gaps in the provision of services to the healthcare industry related to quality assurance and regulatory affairs.
They do so by providing pharmaceutical, biopharmaceutical, and device / diagnostic manufacturers with the skills, experience and resources that they need to succeed.
With thier head office in the UK, EU base in Italy and satellite offices in the US and China — as well as partners in South Korea and Poland — they are truly a global business that understands the intricacies of the regulations across borders worldwide.
And as the only regulatory consultancy in the UK to hold a GMP licence, issued by the MHRA, they don’t just help their client to do the same, but they evidence it every day through our licence maintenance activities.
Their services include:
-Pharmaceuitcal & Biopharmaceutical:
Their team of industry and agency-experienced specialists can support their client every step of the way — from defining their Target Product Profile (TPP) and preclinical / nonclinical development, through to licence submission, approval and maintenance.
With thier combined expertise spanning many decades, they can help to develop and refine regulatory and quality strategies to ensure a smooth and speedy journey to get pharmaceutical and biopharmaceutical products-including biosimilars, monoclonal antibodies, vaccines and toxins-to market efficiently.
-Devices and Diagnostics
The MedTech landscape is evolving rapidly and new and emerging technologies are constantly being developed; that has been increasing the necessity of understanding and complying with new and emerging legislation.
Innovation, regulation, and advancements in science are creating an ever-increasing intensity of competition.
Whether developing a medical device, drug delivery device, or In Vitro Diagnostic (IVD), the industry is being driven to deliver better, faster treatment and diagnosis for patients, as well as less invasive approaches and reduced recovery times.
Their team of expert consultants in medical device and diagnostic regulation can support clients in navigating this complex environment — guiding them through processes and enabling them to enter and succeed in global markets.
The company has developed significant experience in ensuring medical, drug delivery, and IVD products gain certification through robust regulatory and quality strategies, ensuring submissions are tailored to specific needs of the type and class of product. They offer their services and to pharmaceutical, biotechnology, and medical devices companies under a commercial agreement - Advantages and Innovations
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From device design to post-market surveillance, and all the stages in between, they can assist customers to overcome regulatory compliance and quality challenges to deliver their product to patients and healthcare providers that can really benefit.
Covering the EU 2017/745 Medical Device Regulation (MDR) / EU 2017/746 In Vitro Diagnostic Regulation (IVDR), UK Medical Devices Regulations 2002 and the US FDA 21 CFR, among many others, they can support you in gaining certification from an appropriate notified/approved body.
The company has developed significant experience in ensuring medical, drug delivery, and IVD products gain certification through robust regulatory and quality strategies, ensuring submissions are tailored to specific needs of the type and class of product. - Sustainable Development Goals
- Goal 17: Partnerships to achieve the Goal
Partner Sought
- Expected Role of a Partner
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The Company seeks partners involved in the development of healthcare products including:
- Biological products / biopharmaceuticals, monoclonal antibodies, ATMPs, toxins, vaccines, etc as well as Biosimilars
- Pharmaceuticals / generics, including repurposing and reformulating existing active ingredients
- Medical Devices including drug-device combinations
- In vitro diagnostic products
The Company seeks to support such manufacturers to accelerate the development of their products by leveraging the Company’s experience and expertise in navigating complex regulatory frameworks and data requirements to ensure product safety, quality and efficacy. Typically, manufacturers would be small to medium entities that are seeking expert level support and assistance to develop and grow their market to the UK / GB. Such clients may or may not already have strategic plans for the UK / GB market; regardless, the Company will ensure their strategy is optimised. With a GMP license for the UK’s MHRA (WDA, MIA) since 2014, the Company is uniquely placed to ensure its clients comply with the relevant regulatory requirements and enable market access.
The Company has an uncompromising track record in the delivery of client projects and programs, and is highly regarded as a knowledge leader in its field. - Type and Size of Partner
- SME <=10
- SME 11-49
- SME 50 - 249
- Type of partnership
- Commercial agreement
Dissemination
- Market keywords
- 05007007 - Other medical/health related (not elsewhere classified)
- 05007002 - Pharmaceuticals/fine chemicals
- 09003005 - Consulting services
- 05003005 - Drug delivery and other equipment
- 05005022 - Other clinical medicine
- Targeted countries
- All countries