For over 60 years, Tunnell has provided both expert talent and consulting services to clients including Biopharmas, CDMOs, the US Government, incubators, investors and NGOs. We have experience across multiple platforms – including large molecule, vaccines, cell and gene therapy and small molecule – and our subject matter expertise focuses on regulatory, quality, GxP, pre-clinical/clinical, supply chain, manufacturing, CMC and product launch. To learn more, visit us online at http://www.tunnellconsulting.com.
The National Institute for Health and Care Research (NIHR)
The NIHR Life Sciences Industry Hub is your entry point to England’s integrated clinical research system, with coordinated access to UK-wide capability. The Industry Hub’s support is free of charge, funded by the UK Government, and designed to make the UK a globally competitive destination for commercial clinical research. We provide: Single national entry to NIHR – One conversation provides access to our entire integrated commercial trials pathway. Dedicated operational leadership – A named national lead coordinates delivery and manages dependencies across the system. Reliable, data-enabled feasibility – Coordinated once, using real-time capability and capacity to improve predictability. Smarter site selection – Intelligent study placement across health and care settings for speed, quality and performance. Faster start-up – Coordinated oversight of costing, contracting and assurance. Active performance management and escalation – Real-time oversight of set-up and recruitment, with clear escalation routes and time-bound resolution. Inclusive, scalable recruitment – Approaches that improve reach, diversity and reliability, including digitally-enabled and hybrid delivery models. Strategic partnership opportunities – Portfolio-level engagement and longer-term collaboration with the NIHR research system.
Sikich
Sikich LLP is a business and technology consultancy who’s close to 1,500 team members provide advisory, consulting, and technology services to clients in life sciences, manufacturing, professional services, and other industries. The company’s life sciences practice spans the industry and supports more than 200 life sciences clients, including biotechnology and biopharmaceutical companies, CROs, and lab diagnostic companies. As a leading life science technology consultant, we can help you streamline operations and ensure compliance, allowing stakeholders to do what they do best: develop new medicines for patients who need them. | At Sikich, we empower life sciences organizations through strategic planning, regulatory expertise, and digital modernization. From inception to commercialization, we specialize in planning, regulatory, quality, and compliance, leveraging cutting-edge technologies like Oracle NetSuite, Honeywell’s TrackWise Digital, and Kneat’s solutions to streamline operations and accelerate innovation. Our tailored approach combines deep industry knowledge with advanced digital tools, ensuring compliance, enhancing efficiency, and reducing time-to-market for life-changing therapies. A focus on built in audit trails, roles-based control and automated reporting ensure compliance with FDA 21 CFR Part 11, SOX and EU Annex 11. With a commitment to precision, integrity, and transformation, we help companies navigate complex regulatory landscapes and embrace the future of life sciences with confidence. Plan smarter. Modernize faster. Innovate with impact.
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
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.
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.
Pharmadule Morimatsu
Pharmadule Morimatsu is a global leader in modular pharmaceutical and biopharma manufacturing facilities. Pioneering modular delivery since 1986 and part of the Morimatsu Group since 2011, we design, fabricate, and deliver turnkey modular plants—combining process equipment, cleanrooms, and full facility solutions—for the life sciences and consumer products industries. Key benefits: Fixed-price certainty Flexible, scalable modules Rapid deployment worldwide (80% off-site fabrication) Reduced risk in time, cost, and quality From vaccine plants to biotech facilities, we provide fast, reliable, regulatory-compliant solutions delivered anywhere in the world. | We are a world leader in the delivery of innovative modular facilities and process equipment solutions for Life Science Industry. Originally founded in Sweden in 1986, Pharmadule was acquired in 2011 and is now part of the Morimatsu Industrial Group. This strong combination has allowed us to combine process modularization with modular facilities to deliver our clients complete turnkey solutions.
Orbis Clinical Life Sciences Solutions
Orbis Clinical is a leading global recruiting partner to the life sciences industry; we have been driving the success of our clients, consultants, and employees in staffing and consulting services since 2004. We provide multiple solutions spanning permanent and temporary placement to clients ranging from venture-backed start-ups through Fortune 500 firms. Our mission is to provide the world’s leading life science companies with expertise essential to treating devastating diseases.