ObelysQ is a leading quality assurance consulting firm offering tailored solutions to the pharma industry aiming at enhancing compliance and improving processes in the execution of clinical trials. Our Headquarters are in Neuchâtel, with a branch in Poland and one being opened in the USA. With 50+ quality experts, we provide quality assurance and data privacy services all around the globe. GCP/GVP Consulting ObelysQ can provide support in the form of remote consulting done on an as-needed basis or simply be present there on your premises for the time you deem necessary. Together, we can discuss and evaluate the parameters of your project and further decide on what would be the best approach to support your endeavors. We do not believe in a one-size fits all solution and value the partnership and collaboration with our clients. GxP auditing ObelysQ can help you having meaningful and impactful audits. At an early stage, we can help you establish an audit strategy which will ensure an efficient use of your resources. You can also ask ObelysQ to conduct the audits on your behalf, our team has experience with various types of indications, dosage forms, vendors, and systems, and this on all continents! QMS set-up We will create tailored standard operating procedures that are compliant with the regulations, pragmatic enough to allow your staff to consistently and efficiently perform their duties, and adapted to your organization’s size and structure. With experience of developing SOPs for numerous sponsors and CROs, ObelysQ will build your SOPs from scratch or update your existing SOPs to optimize timelines, compliance, adherence and efficiency. Health Authority Inspection Bringing experience in successfully managing dozens of sponsor and site inspections (FDA, MHRA, EMA, CFDA, etc…), ObelysQ will provide your organization with an efficient and collaborative management of all Competent Authorities GCP inspections to maximize the chance of a successful outcome, while engaging your staff and decreasing anxiety. Our collaboration will include the development of a specific inspection plan, evaluation of the risks and potential issues in every aspect of your program/study, communication with all relevant staff, training, interview coaching, set up of the inspections facilities, inspection hosting and/or back room support, development or responses to inspection findings. You can pick and choose depending on your needs and the nature of the inspection. Training In order to provide the best in class GCP/GVP training, we develop and adapt out training material based on your specific needs, regulations and their updates, business best practices and inspection findings. You decide the approach that fits your needs best as we offer all solutions: presenting GCP at Investigator meetings, conducting face to face training sessions, providing online training tailored to your type of project. Gap Analysis ObelysQ will conduct a full clinical gap analysis to assess your staff, facilities, processes, documents and data. You will receive a detailed report with pragmatic recommendations tailored to your organization to strengthen your clinical processes and ensure GCP compliance and inspection readiness. ObelysQ will also support their implementation and conduct an effectiveness check to ensure objectives were met. You can decide to focus on the entire clinical organization or on a single unit such as your Clinical Qualtiy Unit. We’ll identify all areas for improvement to ensure you have best-in-class Clinical Quality structure and processes. Data Protection Support ObelysQ can help increase compliance through a series of distinct services that allows our clients to ensure their staff is adequately informed of important data protection concepts and regulations. -Data protection training (on-site or e-learning) -Data protection (GDPR) gap analysis -Development of data protjection strategies, SOPs and tools -Externalized Data Protection Oficer(DPO) specifically for clinical trials -GDPR-compliance assessment of vendors.
MediTox s. r. o.
MediTox s.r.o. is GLP-certified CRO dealing with preclinical R&D comprehensive preclinical and toxicological program for human/veterinary products (EMA, ICH/VICH, FDA), medical devices (ISO 10993), chemicals and agrochemicals (OECD TG), development of animal models of selected human diseases. Contract research activities are pointed to general toxicology and pharmacology (acute toxicity, long-term toxicity, immunogenicity, safety pharmacology, toxicokinetics, Proof-of-Concept), genetic toxicology (genotoxicity and mutagenicity in vitro and in vivo), biocompatibility of medical devices (local and systemic toxicity, implantation), safety assessment of vaccines, etc. The members of the toxicological team have experience with practically all species including NHP, dogs, ferrets, cats and pigs and various kinds of compounds and indications. Common and special ways of administration are available as well as GLP-compliant platform for bioanalyses, clinical pathology and histopathology. Undisputed advantages are an approval for handling GMO, experience with variety of compounds and therapeutic areas and in preclinical toxicology in non-rodent species, particularly in mini pig, ferret and dog models. C.I.R. accreditation was renewed for 2024 – 2026 OLAW (US National Institutes of Health) approval for 2020 – 2025 | MediTox s.r.o., a long established and fully GLP compliant, preclinical CRO, has been providing safety/efficacy evaluation for nearly 25 years: – non-clinical studies supporting phase I – III CT (exploratory & regulatory studies) – strong expertise in non-rodent toxicology – BEQ/BA/PK/TK studies – medical device (ISO 10993), small molecules, vaccines, biotech derived drugs, veterinary drugs, … (EMA/ICH/WICH/OECD/FDA) – influenza, chronic glaucoma, arthrosis, contact dermatitis models available – revision of study documentation (plan, data, report) MediTox s.r.o. provides specific services in multiples species, customized procedures, and tailored solutions. | x
LSK Global PS
LSK Global PS delivers a comprehensive, end-to-end clinical development model built on 26 years of industry experience, aligning strategy, operations, data, and regulatory functions to minimize delays, reduce risk, and ensure quality. Unified workflows across clinical operations, data management, and biostatistics enable efficient execution and timely submissions, while pharmacovigilance and medical writing are seamlessly incorporated to support submission-ready deliverables. Combined with academic and epidemiological expertise and extensive domestic and global trial experience, this approach strengthens regulatory readiness and supports successful clinical development in Korea.
KBI BioPharma, Inc.
KBI Biopharma, Inc. KBI Biopharma, a JSR Life Sciences company, is a leading global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. With each of its 500+ client partners, KBI works closely to personalize and accelerate drug development programs. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, KBI delivers robust process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. Recognized for quality manufacturing, KBI helps clients advance drug candidates into the clinic and beyond. KBI serves its global clients with multiple locations in Europe and the USA. www.kbibiopharma.com. Selexis SA Selexis SA, a JSR Life Sciences company, is the global leader in cell line development with best-in-class modular technology and highly specialized solutions that enable the life sciences industry to rapidly discover, develop and commercialize innovative medicines and vaccines. Our global partners are utilizing Selexis technologies to advance more than 160 drug candidates in preclinical and clinical development and the manufacture of ten commercial products. As part of a comprehensive drug development process, the Company’s technologies shorten development timelines and reduce manufacturing risks. More information is available at www.selexis.com | KBI Biopharma, Inc., a JSR Life Sciences company, together with its affiliates, is a global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. As a global leader in mammalian cell line development, with best-in-class modular technology and highly specialized solutions, KBI enables the life sciences industry to rapidly discover, develop and commercialize innovative medicines and vaccines. With each of its 500+ client partners, KBI works closely to personalize and rapidly accelerate drug development programs. Global partners are utilizing KBI’s technologies to advance more than 170 drug candidates in preclinical and clinical development and the manufacture of ten commercial products. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, KBI delivers robust process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. Recognized for quality manufacturing, KBI helps partners advance drug candidates to the market. KBI serves its global partners with eight locations in Europe and the USA. More information is available at www.kbibiopharma.com. | KBI Biopharma, a JSR Life Sciences company, is your expert CDMO partner for complex biologics. From development through manufacturing, trust us to solve your challenges, so you can focus on what matters most – the cures. With expertise that accelerates your path to clinic and market through advanced platforms for mammalian and microbial production, deep CMC and analytical capabilities, and end-to-end CLD-to-vial services, KBI biopharma helps you bring even your most challenging molecules to clinic and market with confidence. With platforms that accelerate your path to clinic and market, KBI Biopharma brings deep expertise across mammalian and microbial production, CMC strategy, and advanced analytics. Our end-to-end services, from cell line development to drug product, are built to help you confidently advance even the most complex molecules. Whether it’s mammalian cell line development powered by Selexis®, high-yield PUREcoli™ microbial strains, or robust manufacturing solutions, our integrated approach simplifies your journey from concept to commercialization. You’ll also benefit from PROGRAMview™, our innovative digital platform that brings a new standard of transparency to CDMO partnerships, giving your team real-time access to data, smarter decision-making, and milestone-driven execution. With dual operations in the U.S. and Europe and over 170 molecules supported, we deliver global regulatory insight and solutions tailored to your unique program needs. | KBI Biopharma is the CDMO of choice for complex biologics and expert analytics, helping life science companies accelerate the development and manufacture of innovative therapies and vaccines. With roots in analytical services and deep technical expertise in mammalian and microbial programs, KBI provides process development, analytical, and cGMP manufacturing services across the drug development lifecycle. KBI’s technologies support more than 250 drug candidates in preclinical and clinical development and 15 marketed products. KBI partners with customers to solve challenges, drive breakthroughs, and advance programs to market – serving customers from six locations across the US and Europe. Learn more at www.kbibiopharma.com.
INTERTEK
We go beyond Testing, Inspection and Certification of products: we are a Total Quality Assurance Provider to industries worldwide. With over 40,000 employees in over 1,000 locations in 100 countries, our network of science-based, highly technically skilled individuals and teams enable global and local businesses to overcome the complex quality, safety and sustainability challenges they face, every day. | Intertek is a global leader in product assurance, testing, inspection, and certification. We provide safety and performance testing and certification to help manufacturers meet regulatory requirements, industry requirements, customer specs, or to prove marketing claims about the product. Learn more at www.intertek.com. | Intertek’s Building and Construction division is a suite of Intertek brands that are industry leaders across multiple architecture, engineering and construction disciplines, developing the most innovative product and project solutions.Our experienced staff and comprehensive range of product-related testing and certification capabilities ensures that our clients have a clearly defined path to market, with cost-effective solutions and the ability to operate with pace and precision. Intertek’s project-related assurance, testing, inspection and consulting services are the risk management and quality assurance partner you need to ensure the reliability, safety and performance of your new developments, existing assets and facilities. | Intertek is a global leader in battery testing and certification, conducting over 20,000 evaluations annually across all battery chemistries and sizes, from button cells to EV and grid storage. Backed by a global network of 1,000+ accredited laboratories, we deliver customized Assurance, Testing, Inspection, and Certification services. Trusted by top manufacturers worldwide, our science-based testing ensures products meet stringent quality, safety, sustainability, and performance standards. With precision, pace, and passion, Intertek helps clients navigate regulatory requirements and confidently enter global markets. | Intertek is the worldwide leader in delivering complete quality assurance services to manufacturers throughout the information and communication industry. For decades we have provided the industry with specialized performance testing and independent verification, offering an unsurpassed suite of services to address the needs of the industry. Intertek is a trusted partner in helping ICT companies develop and launch products with less risk, greater quality, and increased revenue potential. | Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. For Total Quality Assurance across safety, performance, and energy efficiency, Intertek has the expertise to quickly bring lighting products to global markets. With a heritage born from Thomas Edison in 1896, we have built an international business model designed to get your high-quality products to market faster than the competition. | Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Leading appliance and electronics manufacturers rely on Intertek for comprehensive testing and certification services, ensuring compliance with global standards for safety, performance, energy efficiency, and more. | Many countries worldwide have adopted compliance requirements and regulations to help ensure the safe use of FCMs. Our team of experts can help manufacturers comply with global industry regulations and standards to expedite market entry, while ensuring the quality and safety of their FCMs. Acting as a 3rd party in the value chain, we will help you coordinate information between business partners, evaluate formulations under NDAs, conduct compliance and analytical testing to ensure compliance of the evaluated products. | Intertek Allentown is an ISO 17025 accredited laboratory that provides advanced analytical tools and expertise for chemicals, materials and product testing, and research & development. Quality and reliable testing services for global compliance and quality control needs. | Intertek is a global leader in battery testing and certification, conducting over 20,000 evaluations annually across all battery chemistries and sizes, from button cells to EV and grid storage. Backed by a global network of 1,000+ accredited laboratories, we deliver customized Assurance, Testing, Inspection, and Certification services. Trusted by top manufacturers worldwide, our science-based testing ensures products meet stringent quality, safety, sustainability, and performance standards. With precision, pace, and passion, Intertek helps clients navigate regulatory requirements and confidently enter global markets. | Intertek delivers global testing and certification solutions for Transmission and Distribution Equipment (TDE). Supporting IEEE, IEC, and UL standards, we help manufacturers and utilities validate safety, performance, and compliance while accelerating time to market. | Did you know Intertek is behind the safety of toys in different parts of the world? Intertek assures the quality, safety, sustainability and performance of all categories of toys while facilitating their global market access to over 50 major markets in the world. Learn more: https://www.intertek.com/toys-childrens-products/
Illinois Economic Development Corporation
Illinois Economic Development Corporation’s mission is to bring jobs, investment, and economic prosperity to the state of Illinois through dynamic partnerships and collaborations with companies, universities, not-for-profit organizations, and the government to deliver a unified approach to economic development. Formerly known as Intersect Illinois.
Harvest Integrated Research Organization (HiRO)
HiRO is a modern global CRO delivering full-service clinical trial support across ANZ (for over 25 years), APAC, US, and Europe. We combine global infrastructure with genuine local expertise, offering sponsors the agility and personalization that larger organizations can’t match, without sacrificing rigor or reach. From regulatory strategy, clinical operation support and management, site identification and management, biometrics, pharmacovigilance and medical monitoring, HiRO accelerates the path from discovery to patients. Highlights ⦁ Modern local CRO operating across ANZ, APAC, US, and Europe ⦁ Full-service: clinical design, regulatory, biometrics, safety, and monitoring ⦁ Global expertise paired with hands-on regional insight ⦁ Agile operations built for faster, cleaner clinical data ⦁ True partnership model, embedded in your team from day one | Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative clinical research organization (CRO). With global operations and integrated capabilities, HiRO provides a full range of cross-border solutions and services to its clients, including early pre-clinical strategic planning, clinical trial design, regulatory affairs, pharmacovigilance, statistics, data management, end-to-end project management, and clinical and medical monitoring services. As an emerging global CRO, HiRO strives to become a market-leading, integrated global clinical research organization that works collaboratively with biotech and pharmaceutical companies to bring new products from the laboratory to the market, providing more effective solutions for patients worldwide.
H&T Presspart
H&T Presspart is a world leader and specialist in manufacturing drug delivery devices and pharmaceutical components. With 50 years experience in partnering with the world’s leading pharma companies we have developed a strong reputation for precision and reliability – critically important when patients’ quality of life depends on our products. Our extensive skills and experience cover drug delivery device development and industrialisation and every aspect of high-volume precision deep-drawn manufacturing, injection moulding and high-speed assembly in ISO 7 and ISO 8 cleanrooms.