SigutLabs, a contract research organization (CRO) located in Prague, Czech Republic, helps businesses from small start-ups to pharmaceutical giants overcome their chemistry challenges. Our agile PhD chemists specialize in custom synthesis, scale-up, and contract research across organic, bioorganic, and medicinal chemistry, with a focus on nucleotide and nucleoside chemistry, ADC linkers, and advanced applications. We excel at developing novel synthetic routes for undescribed compounds and custom synthesis of known molecules, also offering dedicated FTE chemists. We have a lean team of up to 10 employees with every chemist holding a PhD degree, which is an industry-leading scientific staff ratio. All our experts studied at prestigious universities and have extensive experience in organic and medicinal chemistry from top international institutions. Our cutting-edge labs prioritize a sustainable future with eco-friendly practices and invest in top-tier equipment to handle your most complex projects. Products from our inventory are available for purchase through our e-shop, ensuring super-fast and secure delivery worldwide. Founded in 2011, SigutLabs has grown from a small lab to a partner of choice for leading pharmaceutical and Silicon Valley companies. We played a major role in the fight against COVID-19 by developing a new synthetic pathway of remdesivir for research in just four months, and were recognized for our achievements with the 2023 Company of the Year award (Central Bohemia region). Fueled by a vision to build on the legacy of Czech chemistry, exemplified by Prof. Antonín Holý and his groundbreaking molecule tenofovir, we aim to re-establish the Czech Republic’s position on the global chemistry map. We can tackle your toughest challenges with our team’s diverse chemistry experience, including: ADC linkers Heterocyclic chemistry Palladium-catalyzed reactions Organometallic chemistry Nucleoside/nucleotide chemistry Fluorine chemistry Photochemistry Supramolecular chemistry Total synthesis of natural products Modification of enzyme substrates/inhibitors Visit our website at www.sigutlabs.com to see how SigutLabs frees hands, saves costs, and accelerates your projects with our outsourced chemistry expertise. Follow us on LinkedIn to see the latest news. | x
Richmond Pharmacology
Richmond Pharmacology is a leading UK-based contract research organisation (CRO) providing comprehensive clinical research services from First-in-Human (FIH) and First-in-Patient (FIP) through to Phase III studies. For over two decades, we have partnered with pharmaceutical and biotechnology companies globally — particularly across the United States, Europe, and Japan — to deliver faster answers and empower smarter development decisions. Operating from a state-of-the-art clinical pharmacology unit in London, we integrate real-world clinical expertise, regulatory foresight, and operational excellence to support the successful delivery of complex clinical development programmes. Faster Answers for Smarter Decisions At Richmond Pharmacology, “Faster Answers” is our guiding principle. Through a combination of expert-led study design, agile operational models, and strategic regulatory insight, we enable sponsors to generate high-quality data earlier, accelerating programme timelines and reducing development risk. Our Core Expertise Includes: First-in-Human (FIH), First-in-Patient (FIP), and Clinical Development up to Phase III: Extensive experience managing trials from initial dosing through proof-of-concept and pivotal Phase III studies, across a broad range of therapeutic areas. Gene Editing and Gene Silencing Studies: Richmond Pharmacology is proud to support cutting-edge research in advanced therapeutic modalities, including CRISPR-Cas9 genome editing and RNA interference (RNAi)-based gene silencing, helping innovators bring transformative medicines to patients faster. Patient and Healthy Volunteer Studies: Our work spans both healthy volunteer and patient-focused research, with a strategic emphasis towards increasing patient-centric trials to better reflect real-world treatment needs. Rare and Orphan Disease Trials: We are recognised for our ability to design and conduct trials for rare and ultra-rare conditions, navigating recruitment and operational complexities with sensitivity and precision. Bridging Studies: Richmond Pharmacology is a leader in Japanese–European bridging studies, providing critical data to support global strategies. Cardiovascular, Metabolic, and Central Nervous System (CNS) Disorders: Specialist expertise in diseases such as cardiovascular disease (CVD), chronic kidney disease (CKD), hyperlipidaemia, non-alcoholic steatohepatitis (NASH), diabetes, and neurodegenerative or psychiatric disorders. Complex and Adaptive Trial Designs: Expertise in designing seamless adaptive protocols, umbrella trials, and novel methodologies that optimise development pathways while preserving scientific and regulatory integrity. Patient and Public Involvement (PPI): We embed Patient and Public Involvement across study planning and execution, ensuring trial designs are informed by patient perspectives to enhance engagement, experience, and outcomes. Regulatory Strategy and Scientific Consultancy: Richmond Pharmacology provides scientific and regulatory consultancy services, guiding sponsors through regulatory interactions and optimising study designs for approvals in the UK, US, and Europe. Why Partner with Richmond Pharmacology? Our experienced team, operational flexibility, and focus on scientific excellence make Richmond Pharmacology a trusted partner for companies seeking faster, smarter clinical development. Whether advancing a novel genetic therapy, accelerating a rare disease treatment, or bridging critical data across regions, we provide the solutions needed to move innovative therapies forward. For more information, please visit www.richmondpharmacology.com
Repligen
Repligen, a global life sciences company, develops and commercializes innovative bioprocessing technologies that increase efficiencies and flexibility in biotherapeutic manufacturing. As leaders in filtration, chromatography systems, process analytics and fluid management, we are committed to inspiring advances in bioprocessing. We are a trusted partner in the production of monoclonal antibodies, recombinant proteins, vaccines as well as cell and gene therapies. Named one of the fastest growing biotech companies in the USA, the majority of our 18 manufacturing sites are located in the United States (California, Massachusetts, New Jersey, New Hampshire, New York and Texas). Outside the United States, we have manufacturing sites in Estonia, France, Germany, Ireland, the Netherlands, and Sweden. | Repligen, a global, bioprocessing-focused life sciences company, provides innovative solutions for the advancement of biotherapeutic manufacturing. Experts in filtration, chromatography systems, process analytics, fluid management, and proteins, Repligen is a trusted partner serving the development and manufacture of a wide range of biologics, including cell and gene therapies, mRNA, monoclonal antibodies (mAbs), antibody–drug conjugates (ADCs), bispecific antibodies, and fusion proteins. Headquartered in Waltham, Massachusetts, USA, Repligen operates across 22 sites, including locations in the United States, Europe, and the Asia-Pacific region. | Inspiring advances in bioprocessing, Repligen is a trusted partner in process intensification, pre-packed chromatography and single-use filtration. Focused on cost and process efficiencies, our people and our technologies help meet critical bioproduction demands worldwide. As the recognized global leader in Protein A manufacturing, Repligen’s Protein A affinity ligands are routinely used to purify most of the world’s monoclonal antibodies.
PSC Biotech
Founded in 1996, PSC Biotech Corporation is a global organization that has spent over two decades providing life science services and solutions through our professional service consultancy for CQV, CSV, auditing, IT services, and much more. PSC Software provides inspection/audit management and eQMS services and BioTechnique provides CRDMO services. We also distribute equipment (Lives International data loggers and thermal mapping systems). Since its inception, PSC has served as a strategic partner to emerging and established life science companies, helping them bring their life-saving products to market. | PSC Biotech® is a global specialty life sciences consultancy firms, supporting over 1000 clients in more than 35 countries. PSC Biotech Corporation® provides life science services and solutions through our professional service consultancy (CQV, CSA/CSV, Audit, and much more.) PSC Software® provides inspection management and electronic quality management systems that enable businesses to stay compliant while effectively and efficiently delivering products to market. PSC Software® has 4 proprietary, 21 CFR Part 11 compliant, cloud-based systems that accelerate and streamline quality processes. BioTechnique® is a division of PSC Biotech Corporation®. BioTechnique® is a Contract Research, Development, and Manufacturing Organization (CRDMO) that provides lyophilization and therapeutic sterile injectable fill-finish solutions to cater to both large and small investigational/clinical stage or commercial batch sizes. BioTechnique® provides a comprehensive platform for success, beginning with Formulation Studies, extending through Analytical and Formulation Development, and culminating in Product Launch (clinical or commercial). | . | BioTechnique is a CRDMO, pharmaceutical manufacturing facility located in York, PA. A highly potent sterile injectable and clinical oncolytics manufacturing company dedicated to providing cytotoxic and high potency sterile injectable fill-finish services. Our project management and client services staff work closely with clients to meet all their manufacturing needs. We provide formulation and compounding, fill-finish, lyophilization, shipping, storage, and 3rd party logistics for a wide variety of liquid injectables. BioTechnique utilizes our expertise to create process designs for client product needs. To learn more, visit www.biotechnique.com
Profil GmbH
Profil is the world’s leading CRO in metabolic research. As a full-service provider, we conduct early phase clinical trials within the indications of obesity, (pre)diabetes, and diabetes complications. We offer an unrivaled combination of science and professional conduct. This unique combination allows us to design and carry out best-in-class clinical trials for our clients. Our in-house scientific expertise covers pharmacology, obesity and prediabetes, nutritional sciences, cardiometbolic research, hepatology, endocrinology, the entire spectrum of diabetes complications, cell and molecular biology as well as metabolic monitoring and medical technology. One of our core technologies is the hyperinsulinemic euglycemic clamp, used to address action profiles of insulin and insulin analogues, beta cell function and insulin sensitivity. To address human metabolic pathways glucose clamp studies are combined with isotope dilution techniques and tissue biopsies. To be able to offer the best services for any glucose clamping setup, we have developed ClampArt, the next generation of glucose clamping. By owning a continuously updated database with entries of more than 30.000 well characterized individuals (healthy, healthy at-risk, type 1 and type 2 diabetes), we can recruit even the most complex clinical trials. We have a fully GMP certified pharmacy and in-house clinics with 60 beds and holds expertise in Data Management & Statistics and Regulatory Affairs.
Product Life Group
PLG is a global life sciences consulting group helping biopharma companies move products from development to commercialization. Through DSI and Halloran, our North American team brings expertise across regulatory, CMC, quality, clinical development, and program leadership to help clients solve complex challenges and advance with confidence.
PharSafer
Founded in 2003 by Dr Graeme Ladds, PharSafer® is a specialist Contract Research Organisation (CRO) in Global Clinical and Post Marketing Drug Safety, and Medical Services, with a wealth of experience in Pharmacovigilance, Auditing and Medical Affairs – and the various, numerous and extensive legal safety/medical obligations for licence holders to comply with – as well as Regulatory Strategy for the best methods for obtaining scientific advice concerning licence submissions and approvals. Together with our sister company which focuses on Training: SaPhar, PharSafer® continuously seeks new and innovative ways to provide added value for our global clients – going above and beyond expectations and optimising processes and procedures involved with clinical and post marketing drug safety and licencing approach. Our ability to offer first-class services in Pharmacovigilance, Regulatory Affairs, Training, Auditing, Medical Affairs and IT Informatics means that, for many clients, we operate as their Pharmacovigilance and Medical Departments – guiding them through the labyrinth of drug safety and medical legislation, all in the interests of ensuring patient safety and client compliance. We love what we do. We love finding solutions. Quite simply, we are by far… Your leading partner in Drug Safety. | PharSafer is a Global CRO specialising in Clinical & Post Marketing Pharmacovigilance; Medical Affairs; Training; Auditing; IT Informatics and Regulatory Intelligence. PharSafer have been operating for the last 23 years growing annually and helping take Companies from their clinical to post-marketing phases and many clients have been with us over 10 years now. PharSafer have attended over 100 inspections on behalf of clients to aid their compliance and ensure Regulatory Authorities are satisfied with the activities being performed. PharSafer are also an innovative Company designing validated and automated systems to provide cost-effective solutions for clients and ensure Regulatory compliant systems. Our client base is truly global being in all continents and for clients that have drugs; devices; vaccines; biologics; advanced therapies; biosimilars; herbal and cosmetics. Our Team within the Company are very experienced (many with over 15 years experience) aided by our sister training Company (SaPhar) to provide new updates for clients on country specific regulations with regular monthly contacts and comments going to all clients. We would be happy to engage with you and talk about product development; product expansions into new countries; product launches and perform all of the activities mentioned above. Please review of website and we look forward to engaging with you personally.
Pharmtrace Klinische Entwicklung GmbH
pharmtrace is an independent CRO providing strategies and solutions for clinical trials. pharmtrace offers flexible services and a global reach for studies with imaging endpoints, radiopharmaceuticals, and radiological interventional procedures. pharmtrace’s experienced team and international medical specialists network ensure that your investment in medical imaging, radiopharmaceuticals and radiological interventions delivers meaningful data. With our GCP compliant image management platform (ERICA) we support you to generate robust data to convince authorities and decision makers, and to achieve your development target. pharmtrace’s customers include biotech and academia, as well as internationally engaged pharmaceutical companies and device manufacturers. | Full-service clinical trial management by a team that understands imaging and radiopharmaceuticals as deeply as clinical operations. pharmtrace is a private, independent contract research organisation for the pharmaceutical and medical device industry. We focus on clinical studies where diagnostic imaging and/or nuclear medicine approaches are a major component for efficacy or safety assessment — including RECIST-based oncology trials, therapeutic radiopharmaceutical programmes, and medical device investigations. Our clients are global pharmaceutical companies, biotech firms, and academic sponsors across North America, Europe, and Australasia. We have managed clinical trials across oncology, neurology, cardiology, and other therapeutic areas — from first-in-human exploratory studies through Phase 3 registration trials and Phase 4 post-marketing commitments. In each, imaging expertise was built in from the protocol stage, not retrofitted. Our experience includes studies that have supported marketing authorisation applications to FDA and EMA. We know what these submissions require and design our processes accordingly from the outset. pharmtrace’s Imaging Core Lab provides comprehensive support for all imaging aspects of clinical trials and medical device investigations. Whether your study applies RECIST 1.1 or iRECIST for tumour response in oncology, PERCIST for PET-based assessment, quantitative MRI endpoints in neurology, SPECT imaging in cardiology, or quantitative imaging for a medical device investigation — we standardise, collect, quality-control, and independently review images with the rigour that regulatory submissions require. Our proprietary ERICA platform, validated to GAMP5 Category 5, serves as the single environment for DICOM image storage, technical and medical QC, and blinded read sessions — with per-study configuration validation for every project. We support sponsors at any stage — from early imaging strategy and endpoint selection through regulatory meeting preparation and marketing authorisation support. Our advice is grounded in operational experience, not theory.