Only Orphans Cote is the leading global orphan product development regulatory affairs consulting firm. Led by a former Director of the Office of Orphan Products Development, Dr. Tim Cote spearheaded the agency’s efforts in implementing the Orphan Drug Act and personally signed decisions on over 1,400 orphan drug designation applications. | Only Orphans Cote LLC is a regulatory affairs consulting firm leveraging its expertise and commitment to delivering drugs for rare diseases. We crystallize our clients’ drug development work into products and documents, securing FDA and EMA Orphan Drug Designations (ODD) as well as all other actions that advance to marketing authorization. In doing so, we enhance investment and asset valuation in the orphan drug market. | Only Orphans Cote LLC is a regulatory affairs consulting firm leveraging its expertise and commitment to delivering drugs for rare diseases. We crystalize our clients’ drug development work into regulatory tangibles. In doing so, we enhance asset valuation, investment attractiveness and exit options.
ObelysQ SA
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.
Novotech
Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company that provides biotech and small- to mid-sized pharma companies an accelerated path to market since 1997. With a global footprint spanning 30+ offices across the Asia-Pacific region, North America, and Europe, and partnerships with 5,000+ trial sites, Novotech offers unparalleled access to key clinical trial destinations and diverse patient populations. Novotech leverages its therapeutic and regulatory expertise, client-centric service model, local market insights, and advanced analytical tools to expedite patient recruitment, enhance trial efficiencies, and bring life-changing therapies to market faster. This work has been recognized by awards such as the Frost & Sullivan CRO Company of the Year, which Novotech has received for 19 consecutive years.
Mexico Pavilion (MEX BIO)
MEX BIO Pavilion – BIO International Convention 2026 The MEX BIO Pavilion represents Mexico’s coordinated national presence at the BIO International Convention, the world’s leading global event for biotechnology and life sciences. Since 2022, Mexico has maintained a continuous and growing participation at BIO through a national pavilion, reflecting the strategic importance of the life sciences sector for the country and the sustained collaboration between industry, government, academia, and innovation stakeholders. MEX BIO serves as a platform for international engagement, business development, and ecosystem positioning, bringing together Mexican pharmaceutical and biotechnology companies, CROs and CDMOs, startups, research institutions, clusters, and public agencies. Over the past four editions, more than 50 Mexican organizations have participated, positioning Mexico as a key life sciences hub in Latin America and a reliable partner for global collaboration. The Pavilion is designed to go beyond a traditional exhibition space. Through a curated program of activities—including MEX BIO Day, MEX BIO Talks, MEX BIO Walks, and high-level institutional engagements—the Pavilion facilitates targeted meetings, strategic dialogues, and direct interaction with international partners, investors, and decision-makers. A dedicated digital platform and ecosystem wall further enhance visibility and extend engagement before, during, and after the Convention. Mexico’s presence at BIO reflects the country’s commitment to innovation, advanced manufacturing, regulatory dialogue, and international cooperation in life sciences. The MEX BIO Pavilion offers global stakeholders a unique entry point to explore Mexico’s capabilities, connect with its innovation ecosystem, and identify opportunities for collaboration, investment, and market access in one of the region’s most dynamic life sciences environments.
MEDIAIPLUS, Inc.
MEDIAIPLUS address major bottlenecks in the clinical trial process by leveraging the world’s largest clinical trial dataset and advanced AI technology. Our two flagship solutions are: – MediC: A subscription-based platform offering real-time access to over 720,000 clinical trial reports, patents, regulations, and guidelines. – FiCRO: An AI-powered matching engine that connects sponsors with the most suitable CROs based on 20+ data points, including past performance history and RFP criteria. MEDIAIPLUS is trusted by global stakeholders in pharmaceutical, biotech, and medical device industries for accelerating clinical trial efficiency and decision-making. | “Create a virtuous cycle in clinical trials to provide more treatment opportunities for patients.” MEDIAIPLUS provides innovative solutions to help pharmaceutical, biotech, and medical device companies conduct clinical trials more efficiently. To address bottlenecks in the clinical trial process, we have built the world’s largest clinical trial dataset and leverage AI to generate groundbreaking insights. To achieve this, MEDIAIPLUS offers two key solutions. MediC is a subscription-based service that provides real-time access to a vast database of clinical trial reports, patents, regulations, and guidelines. FiCRO is an AI-driven solution that matches sponsors with the most suitable CROs for their specific clinical trials based on RFPs. MEDIAIPLUS’ AI-powered innovations in clinical trials have gained significant attention and recognition from key players in global clinical research. | MEDIAIPLUS offers solutions to significantly reduce the time and cost of clinical trial preparation. We hold the largest clinical trial dataset in the world and leverage AI to help researchers prepare for clinical trials. Through our solutions, we tackle bottlenecks in trials and create more treatment opportunities for patients.
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.
Intrinsik Corp.
As a recognized leading scientific and regulatory consulting firm within the pharmaceuticals and biotechnology industries, our team of scientific and regulatory consultants will help you identify the most efficient drug development and registration pathways. As a science-based consulting firm with clients from all over the world, Intrinsik’s full-time, in-house, scientific and regulatory consultants will support the development of a wide range of human health products, including small molecules, biologics, cell and gene therapies, natural health products (NHPs), and cosmetics from the preclinical stage through to market and the post-approval phase. Intrinsik’s Services: Regulatory Affairs Consulting Nonclinical Consulting Medical Writing Chemistry, Manufacturing and Controls (CMC) Regulatory Operations Toxicological Services
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/