Deibel Laboratories

AT CELLCARTA WE ARE DEDICATED TO WORKING WITH OUR PARTNERS TO FURTHER THE LIMITLESS POTENTIAL OF PRECISION MEDICINE

As a global contract research organization (CRO) laboratory, we partner with our clients to address the most complex biomarker and bioanalytical challenges and deliver highly customized testing solutions. With facilities located in Canada, United States, Belgium, Australia and China, CellCarta provides the expertise needed locally to support global clinical trials.

CellCarta offers access to integrated analytical platforms in immunology (immune monitoring), histopathology, proteomics and genomics, as well as sample logistics services.

At CellCarta we are experts at assessing the immune system, whether in the context of oncology, infectious diseases, or autoimmune diseases. With a proven track record in other therapeutic areas as, such as neurological and metabolic disorders, we handle all human biological specimens and deploy relevant technologies to extract valuable information for research and diagnostic applications. We provide assay development and testing services to support a wide variety of translational research, clinical trials, and diagnostic applications.

Committed to delivering the highest quality science and innovation, CellCarta recently acquired Clinical Logistics to expand its specialty specimen logistics and kitting services and Mosaic Laboratories for multiplex immunohistochemistry assays development and deployment.

Reflecting our commitment to quality, our sites hold the appropriate accreditations to support your regulatory requirements, inNeo-Epitope Discoverycluding CAP, CLIA, ISO15189 and ISO13485.

CellCarta is privately held and majority-owned by Arsenal Capital Partners.

BIONEEDS INDIA PRIVATE LIMITED is a Bangalore based Contract Research Organization providing Integrated Discovery, Development and Regulatory Services to Pharmaceutical,
Biopharmaceutical, Agrochemical, Industrial chemical, Herbal/Nutraceutical and Medical device companies.

Accreditation/Certifications
• National GLP Compliance Monitoring Authority (NGCMA), Dept. of Science and Technology, Government of India
• Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Ministry of Environment, Forests and Climate Change, GOI.
• State Drug Controller as a Government approved Drug Testing Laboratory for carrying out tests on Drugs / Cosmetics and
• Raw Materials used in their manufacture on behalf of licensees for manufacture for sale of drugs / cosmetics
• Review Committee on Genetic Manipulation (RCGM), department of biotechnology, GOI to conduct experiments on animals for DNA or Genetically modied resources
• Bioneeds is AAALAC certified for laboratory animal care
• Bioneeds’ in-house R & D unit is recognised by Department of Scientic and Industrial Research (DSIR)
• ISO 17025 certified for Biological evaluation of Medical Devices
• Bioneeds has best-in-class infrastructure equipped with state-of-the-art facilities with 2,50,000 sqft built-up area.
• Vivarium with 85 exclusive animal rooms built as per international standards
• Cutting edge Drug Discovery and Development Labs to support Medicinal chemistry, Biology, In vivo Pharmacology,
• Toxicology, Custom synthesis, Process R&D, cGMP manufacturing, Formulation and Analytical development services

PREMIUM PHARMACEUTICAL INGREDIENTS - MANUFACTURED EXCLUSIVELY IN THE USA
BioSpectra is a US Based manufacturer of GMP, pharmaceutical grade ingredients, including Actives, Excipients, GMP Process Chemicals & Bulk GMP Buffers and Solutions. Our focus is small molecule synthesis and true, phase change multi-step purification for both traditional and bio-pharmaceutical applications. Our services include Contract GMP product development coupled with ongoing commercial manufacturing and regulatory support up to and including DMF submissions. All of our manufacturing processes are fully validated. Our US-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Our onsite analytical testing capabilities include multi-compendial and custom specifications with full traceability and transparency of all raw materials and sources.

Our commitment is to quality, compliance and true, US-GMP manufacturing, testing and regulatory support is unparalleled. We own and operate out of 175,000 square feet of FDA registered & inspected GMP manufacturing space, under the most rigorous quality system while holding to the most stringent regulatory demands. Our goal is to be a valued partner in the secure supply chain and the solution to any key ingredient issue our customers may have.

GMP Product Categories:
• Bulk, GMP Biological Buffers
• Active & functional Excipients
• GMP Process Chemicals and Bulk GMP Solution Solutions

Custom GMP Services Include:
• Purification of Key Ingredients
• Full GMP Product Development
• Small Molecule Custom Synthesis
• API Development & Manufacturing
• Custom GMP Compounded Solvents & Solutions

Comprehensive Quality and Regulatory Program
• FDA Registered and Inspected
• Document Support - DMF Submissions
• Global GMP Requirements – US, IPEC, ICH Q7

Samsung Biologics is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity at a single site, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.

Accell Clinical Research is an international full-service Contract Research Organization (CRO) managing Phase I-III clinical trials for 10+ years across Eastern Europe. With local presence, including highly qualified medical staff and legal entities in the region, we successfully recruit patients both in EU and outside EU in post-Soviet countries (CIS). All together we provide guaranteed fast patient recruitment in 20+ countries across the region.

⬇︎ ACCELL'S SERVICES for Phase I-III clinical trials:

• Strategic guidance and trial set-up:
• Feasibility research and site selection
• Study documentation development
• Regulatory support
• Clinical supply import and management
• Selection and management of clinical study vendors
• Project management
• Clinical & medical monitoring
• Data management and biostatistics
• Quality assurance
• Safety management
• TMF/eTMF services
• Functional outsourcing of a clinical team

⬇︎ THERAPEUTIC AREAS
• Oncology
• Cardiovascular
• Immunology
• Gastroenterology
• Neurology
• Endocrinology