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  • Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines

    Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines

    Clinical/Medical Sciences san Jose (california) May 15, 2021 Check with publisher

    Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to have procedures in place to ensure suitable levels o...

  • Designing and Sustaining New and Existing Product Stability Testing Program

    Designing and Sustaining New and Existing Product Stability Testing Program

    Drug Development san Jose (california) May 15, 2021 1699.00 Dollar US$

    New or existing modified drug Stability Testing Program's regulations/requirements stipulated by the FDA, 21 CFR or other regulations may sometimes creating an overwhelming situation based on the type of product that is being manufactured. Hence, som...

  • Process Validation Guidance Requirements (FDA and EU Annex 15

    Process Validation Guidance Requirements (FDA and EU Annex 15

    Pharmacology - Drug Development san Jose (california) May 15, 2021 Check with publisher

    The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manu...

  • Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

    Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

    Pharmacology - Drug Development san Jose (california) May 15, 2021 Check with publisher

    Today, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering latter stages of Phase 2 or Phase 3 clinical trials, and plan to have a...

  • FDA's Medical Device Software Regulation Strategy

    FDA's Medical Device Software Regulation Strategy

    Medical Sciences san Jose (california) May 15, 2021 Check with publisher

    The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjun...

  • The Veterinary Drug Approval Process and FDA Regulatory Oversight

    The Veterinary Drug Approval Process and FDA Regulatory Oversight

    Drug Development san Jose (california) May 15, 2021 1699.00 Dollar US$

    The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species. This seminar will cover the process f...

  • Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry

    Latin America - Understanding Regulatory Compliance Requirements Across the Life Science Industry

    Clinical san Jose (california) May 15, 2021 1099.00 Dollar US$

    This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, IVDs, Biologics, Biosimilars, Orphan Drugs and Combination Products in Latin America. The primary countries covere...

  • IVTScrip™ mRNA-Anti-CD37, 177lu-DOTA-HH1(Cap 1, 2-Thio-UTP, 30 nt-poly(A))

    IVTScrip™ mRNA-Anti-CD37, 177lu-DOTA-HH1(Cap 1, 2-Thio-UTP, 30 nt-poly(A))

    Drug Development (United States ) May 14, 2021 Check with publisher

    This product GTTS-WQ290MR is a type of mRNA having 30 nt poly(A) tail and modified with Cap 1 & 2-Thio-UTP. It ecodes the monoclonal antibody that targets CD37 gene. The antibody can be applied in research. https://mrna.creative-biolabs.com/ivtsc...

  • IVTScrip™ mRNA-Anti-CD37, 177lu-DOTA-HH1(Cap 0, 2-Thio-UTP, 30 nt-poly(A))

    IVTScrip™ mRNA-Anti-CD37, 177lu-DOTA-HH1(Cap 0, 2-Thio-UTP, 30 nt-poly(A))

    Drug Development (United States ) May 14, 2021 Check with publisher

    This product GTTS-WQ289MR is a type of mRNA having 30 nt poly(A) tail and modified with Cap 0 & 2-Thio-UTP. It ecodes the monoclonal antibody that targets CD37 gene. The antibody can be applied in research. https://mrna.creative-biolabs.com/ivtsc...

  • IVTScrip™ mRNA-Anti-CD37, 177lu-DOTA-HH1(Cap 1, 2-Thio-UTP, 120 nt-poly(A))

    IVTScrip™ mRNA-Anti-CD37, 177lu-DOTA-HH1(Cap 1, 2-Thio-UTP, 120 nt-poly(A))

    Drug Development (United States ) May 14, 2021 Check with publisher

    This product GTTS-WQ288MR is a type of mRNA having 120 nt poly(A) tail and modified with Cap 1 & 2-Thio-UTP. It ecodes the monoclonal antibody that targets CD37 gene. The antibody can be applied in research. https://mrna.creative-biolabs.com/ivts...

  • IVTScrip™ mRNA-Anti-CD37, 177lu-DOTA-HH1(Cap 0, 2-Thio-UTP, 120 nt-poly(A))

    IVTScrip™ mRNA-Anti-CD37, 177lu-DOTA-HH1(Cap 0, 2-Thio-UTP, 120 nt-poly(A))

    Drug Development (United States ) May 14, 2021 Check with publisher

    This product GTTS-WQ287MR is a type of mRNA having 120 nt poly(A) tail and modified with Cap 0 & 2-Thio-UTP. It ecodes the monoclonal antibody that targets CD37 gene. The antibody can be applied in research. https://mrna.creative-biolabs.com/ivts...

  • IVTScrip™ mRNA-Anti-CD37, 177lu-DOTA-HH1(Cap 1, 5-Methoxy-UTP, 30 nt-poly(A))

    IVTScrip™ mRNA-Anti-CD37, 177lu-DOTA-HH1(Cap 1, 5-Methoxy-UTP, 30 nt-poly(A))

    Drug Development (United States ) May 14, 2021 Check with publisher

    This product GTTS-WQ286MR is a type of mRNA having 30 nt poly(A) tail and modified with Cap 1 & 5-Methoxy-UTP. It ecodes the monoclonal antibody that targets CD37 gene. The antibody can be applied in research. https://mrna.creative-biolabs.com/iv...

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