Company Category: CMC CRO

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

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Propharma

At ProPharma, we help pharmaceutical, biotechnology, and medical device companies bring life-changing therapies to market. From early development through clinical, regulatory approval, and commercialization, we provide expert guidance to navigate complex challenges and accelerate success. Our mission is simple – improving patient health and safety by delivering the highest quality regulatory, compliance, clinical research, pharmacovigilance, and medical information services throughout the entire product lifecycle. | For over 25 years, ProPharma has partnered with biotech, pharmaceutical, and medical device organizations to bring groundbreaking therapies to market. Offering a fully customizable, end-to-end suite of services, we empower our clients to overcome regulatory complexities and deliver life-changing therapies to patients worldwide. At ProPharma, we help pharmaceutical, biotechnology, and medical device companies bring life-changing therapies to market. From early development through clinical, regulatory approval, and commercialization, we provide expert guidance to navigate complex challenges and accelerate success. Our mission is simple – improving patient health and safety by delivering the highest quality regulatory, compliance, clinical research, pharmacovigilance, and medical information services throughout the entire product lifecycle.

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ProJect Pharmaceutics (PJP)

PJP is the go-to specialist in formulation and process development across complex biologics, bioconjugates, and other therapeutic modalities. Our development agility spans liquid, frozen, and lyo formats in vials, cartridges, or pre-filled syringes and in-step or independent from your chosen manufacturer. Let’s solve your formulation and process challenges together.

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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.

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NONA BIOSCIENCES

Nona Biosciences is a biotechnology company offering integrated solutions for antibody discovery and development. Leveraging our proprietary Harbour Mice® platforms, which generate fully human H2L2 and heavy chain-only antibodies (HCAbs), we enable a broad range of therapeutic formats with high developability and flexibility. Nona’s HCAbs are the first and only clinically validated, fully human heavy chain-only antibodies on the market, offering advantages such as low immunogenicity, high solubility, and strong biophysical properties. Our H2L2 Open Access Platform enables rapid entry into discovery, while Modalities-on-Demand™ provides tailored support for bispecifics, TCEs, and other next-generation modalities including ADCs, CAR-T, and mRNA-based therapies. With capabilities spanning immunization, screening, engineering, and IND-enabling services, Nona empowers partners to move efficiently from idea to IND with flexibility and confidence. Our platforms have supported more than 300 discovery programs and over 19 partner INDs through a variety of collaboration models. | Nona Biosciences is a Boston-based Biotechnology company specialized in fully human antibody discovery. Harbour Mice®, our proprietary technology, are fully human transgenic mice platforms for either conventional fully human antibody (H2L2) or heavy chain only (HCAb) antibody discovery, engineering, and development. The HCAb platform produces human Vh single domain antibodies, providing multiple advantages for bispecific and multispecific antibody engineering | Nona Biosciences is a Boston-based Biotech company specialized in fully human therapeutic antibody technology. Our proprietary Harbour Mice® technology are fully human transgenic mice platforms for either conventional fully human antibody (H2L2) or heavy chain only (HCAb) antibody discovery, engineering, and development. The HCAb platform is fully optimized and clinically validated with global patented protection. Nona Biosciences can provide comprehensive antibody discovery services from Idea to IND, which range from Beacon® Single B Cell Cloning, display technology to functional screening, characterization, in vivo efficacy assessment, antibody engineering, and CMC for clinical candidate generation. | Nona Biosciences is a biotechnology company offering integrated solutions for antibody discovery and development. Leveraging our proprietary Harbour Mice® platforms, which generate fully human H2L2 and heavy chain-only antibodies (HCAbs), we enable a broad range of therapeutic formats with high developability and flexibility. Nona’s HCAbs are the first and only clinically validated, fully human heavy chain-only antibodies on the market, offering advantages such as low immunogenicity, high solubility, and strong biophysical properties. Our H2L2 Open Access Platform enables rapid entry into discovery, while Modalities-on-Demand™ provides tailored support for bispecifics, TCEs, and other next-generation modalities including ADCs, CAR-T, and mRNA-based therapies. With capabilities spanning immunization, screening, engineering, and IND-enabling services, Nona empowers partners to move efficiently from idea to IND with flexibility and confidence. Our platforms have supported more than 300 discovery programs and over 19 partner INDs through a variety of collaboration models. Nona Biosciences is a biotechnology company offering integrated solutions for antibody discovery and development. Leveraging our proprietary Harbour Mice® platforms, which generate fully human H2L2 and heavy chain-only antibodies (HCAbs), we enable a broad range of therapeutic formats with high developability and flexibility. Nona’s HCAbs are the first and only clinically validated, fully human heavy chain-only antibodies on the market, offering advantages such as low immunogenicity, high solubility, and strong biophysical properties. Our H2L2 Open Access Platform enables rapid entry into discovery, while Modalities-on-Demand™ provides tailored support for bispecifics, TCEs, and other next-generation modalities including ADCs, CAR-T, and mRNA-based therapies. With capabilities spanning immunization, screening, engineering, and IND-enabling services, Nona empowers partners to move efficiently from idea to IND with flexibility and confidence. Our platforms have supported more than 300 discovery programs and over 19 partner INDs through a variety of collaboration models.

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NJ Bio

NJ Bio, Inc. is a CRO/CDMO specializing in integrated chemistry and biology services for ADCs and other complex bioconjugates. We offer comprehensive solutions spanning discovery, development, characterization, optimization, and bioanalysis, complemented by robust in vitro and in vivo capabilities to support translational decision-making. We provide toxicology, pharmacology, PK, and immunology services to support safety assessment, efficacy profiling, and translational development of ADC and bioconjugate programs. Our expertise in synthetic chemistry, bioconjugation, linker design, and bioanalytical capabilities, ensure seamless support across the entire drug development process and help accelerate ADC programs to become front-line treatments for cancer patients. | NJ Bio, Inc. is a CRO/CDMO that provides high-quality integrated chemistry and biology services to clients mostly from the biotech and pharma sectors. Main service areas include antibody-drug conjugates, bioconjugation, and multistep organic synthesis. The company is headquartered in Princeton, New Jersey, with additional chemistry facilities in Bristol, Pennsylvania. NJ Bio’s facility in Princeton, NJ, occupies ~ 80,000 sq ft of laboratory and office space, with specialized laboratory suites for highly potent compound synthesis, bioconjugation, bioassays, and analytical studies. The facility is very well equipped with instrumentation required for ADC- and bioconjugation-related work. | NJ Bio, Inc. is a CRO/CDMO specializing in integrated chemistry and biology services for ADCs. We offer comprehensive solutions for ADC development, characterization, optimization, and bioanalysis. Our expertise in synthetic chemistry, bioconjugation, linker design, and bioanalytical capabilities, ensure seamless support across the entire drug development process and help accelerate ADC programs to become front-line treatments for cancer patients. | NJ Bio, Inc., is a CRO that provides high-quality integrated chemistry and biology services for ADCs, bioconjugates and nucleic acid-based therapeutics. We strive to be a beacon of excellence in contract research, development and manufacturing by providing cutting-edge biopharmaceutical and advanced chemistry services. Backed by deep expertise in bioconjugation & chemical synthesis, we add value to targeted therapeutic programs through integrated services in conjugation, process development, characterization, and bioanalysis of complex molecules.

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NanoTag Biotechnologies GmbH

Custom-tailored single-domain antibody solutions We provide high-quality single-domain antibodies (sdAbs) to advance research and biomedicine. From tailored sdAb discovery and innovative technologies to tools for immunofluorescence, super-resolution microscopy, and affinity purification, our solutions ensure reliability and precision. With custom-engineered nanobodies and protein production services, we empower you to tackle complex scientific challenges with confidence. Unlock the full potential of sdAbs with NanoTag Biotechnologies.

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Medicilon USA Corp

Medicilon is a leading CRO company that provides comprehensive drug R&D services on a global scale. From drug discovery, pharmaceutical research to preclinical research, Medicilon has supported more than 2000 client R&D programs worldwide resulting in 520 IND filings. With proven scientific excellence and FDA-aligned methodologies, we help biotech and pharmaceutical innovators fast-track their path from discovery to IND success. | Medicilon is a leading CRO company that provides comprehensive drug R&D services on a global scale. Medicilon has 21 years experience in the industry and has supported more than 2000 client R&D programs worldwide resulting in 580 IND filings. The company has over 441,320 ft2 of chemistry labs with > 1300 chemists located at three different sites. With operations in the USA, China, and Europe, Medicilon is a leading CRO offering integrated pharmaceutical R&D services, including DMPK/PD, toxicology (GLP and non-GLP), chemistry, discovery biology, and CMC research. In addition, Medicilon offers attractive large animal models (non-human primates, dogs, rabbits, and miniature pigs), tumor & non-tumor animal models (including Xenograft models, PDX / PDXO models), and support for simultaneous U.S. IND filing to streamline global drug development and approval.

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JIANGSU YAOHAI BIO-PHARMACEUTICAL Co. ,Ltd

Yaohai Biopharmaceutical Co., Ltd. was founded in August 2010. It has served as a Microbial CRDMO (Contract Research, Development, and Manufacturing Organization) specializing in microbial expression systems and offering one-stop services, including microbial strain engineering, microbial cell banking, process development, pilot scale-up, cGMP-guided manufacturing, fill and finish, analysis and testing, etc. Since its establishment, we have been focusing on “VLP vaccine, peptide, cytokine, nano-antibody, enzyme, plasmid DNA, mRNA, and others recombinant proteins or nucleic acids” as vaccines or therapeutics for human, veterinary, and pet health management. | Yaohai Bio-Pharma, founded in August 2010, is a specialized Microbial CRDMO (Contract Research, Development, and Manufacturing Organization) offering end-to-end services based on microbial expression systems. Our integrated solutions span strain engineering, cell banking, process development, cGMP manufacturing, analytical testing, fill-finish, and regulatory support. We focus on recombinant protein/peptide, nano-body, mRNA, plasmid DNA, VLP vaccines and other modalities for both human and veterinary use. Core Strengths: 1. Comprehensive Service Platform: Covering the full development cycle—from preclinical to commercial production—under global regulatory standards (NMPA, FDA, EMA). 2. Advanced Manufacturing Capacity: 5 drug substance lines with a total microbial fermentation capacity of 7,500L (2L–2,000L), plus 2 drug product workshops for sterile fill-finish of vials (liquid/lyophilized powder) and pre-filled syringes/cartridges. 3. Scalable Solutions: Supporting rapid scale-up with GMP-compliant facilities and fermentors ranging from 2L to 2,000L. 4. Proven Expertise: A seasoned team with 15+ years of experience, delivering over 200 successful projects across diverse therapeutic areas.

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HitGen

HitGen Inc. (SSE: 688222.SH), founded in 2012, is headquartered in Chengdu, China, with subsidiaries in Cambridge, UK and Houston, USA. HitGen is committed to building a world-class innovative biopharmaceutical enterprise and contributing to the better life and health of mankind. Engaged in the discovery and optimization of small molecules and nucleic acid drugs, HitGen dedicates itself to cultivating an internationally leading drug discovery and optimization system centered on four key technology platforms, including DNA-encoded library technology (including DEL design, synthesis and screening, and application expansion), fragment-based drug discovery and structure-based drug design technologies (FBDD/SBDD), synthetic therapeutic oligonucleotide technology (STO), and targeted protein degradation technology (TPD). It provides new molecular entities (NMEs) at different stages of research and development for the pharmaceutical industry, through its diversified business models including research and development services, out-licensing of projects at different R&D stages, and new drug launches in the long term, with an aim to address unmet clinical needs with innovative therapeutic solutions. As a leader in the field of DEL technology, HitGen has been committed to the development, application and improvement of DEL technology since its establishment. By June 30, 2022, HitGen’s DELs contains more than 1.2 trillion novel, diverse, drug-like small molecules and macrocyclic compounds. These compounds are members of DELs synthesized from many thousands of distinct chemical scaffolds, designed with tractable chemistry, and have yielded proven results for the discovery of small molecule leads against precedented and unprecedented classes of biological targets. Through systematic DEL compound design, HitGen DELs has involved the use of more than 6000 different types of chemical scaffolds, which includes most of the core scaffolds of currently approved small-molecule drugs and many privileged scaffolds of small-molecules in clinical trials, and the approximately 40,000 different building blocks. HitGen has approximately 20 in-house drug discovery projects at different stages of research and development, among which 4 have obtained IND approvals and entered into clinical trials. HitGen is in collaboration with pharmaceutical, biotech and chemical companies, foundations and research institutes in the Americas, Asia, Europe, Africa, and Oceania. For more information, please call +86-28-85197385, +1-508-840-9646 or visit www.hitgen.com. For business development: bd@hitgen.com | HitGen Inc. (SSE: 688222.SH), is a drug discovery research company with headquarters in Chengdu, China, and subsidiaries in Cambridge, UK and Houston, USA. HitGen has established leading technology platforms to enable the discovery and optimization of small molecules and nucleic acid drugs. Our key technology platforms include world-leading DNA-encoded library technology (DEL), fragment-based drug discovery and structure-based drug design technologies (FBDD/SBDD), as well as the emerging technology platforms for synthetic therapeutic oligonucleotide technology (STO), and targeted protein degradation technology (TPD). Through our diverse and flexible business models, we have built up collaboration partnership with several hundred biopharmaceutical research organizations worldwide. HitGen has multiple programmes from early discovery to clinical trial stage. | About HitGen Inc. HitGen Inc. (SSE: 688222.SH), is a drug discovery research company headquartered in Chengdu, China, with subsidiaries in Cambridge, UK and Houston, USA. HitGen has established leading technology platforms to enable the discovery and optimization of small molecules and nucleic acid-based drugs. Our key technology platforms include world-leading DNA-encoded library technology (DEL), fragment-based drug discovery and structure-based drug design technologies (FBDD/SBDD), as well as the emerging technology platforms for oligonucleotide-based therapeutics (OBT), and targeted protein degradation technology (TPD). Meanwhile, we are developing a DEL+AI+ Automated DMTA (Design-Make-Test-Analyze) molecular optimization platform to accelerate the discovery and optimization process of preclinical candidate compounds. Through our diverse and flexible business models, we have built up collaboration partnerships with several hundred biopharmaceutical research organizations worldwide. HitGen has multiple programmes from early discovery to clinical trial stage.

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