FoodTech

    FoodTech

    The FoodTech industry is rapidly evolving, reaching a peak in 2020 with a variety of products emerging on the development landscape and some overcoming the quality and regulatory hurdles to reach the consumer market. With regulations and guidance changing rapidly, it requires a concerted effort to keep track. Gsap’s broad expertise in the development of cell-based, biotechnology and pharmaceutical products, quality, animal testing and regulation, is a significant advantage in assisting our clients in this novel industry.

    SERVICES

    fda approved

    Regulation

    The range of products being developed in the field of plant-based, cell-based and flora-based products is enormous. Regulatory classification of each product will determine the set of particular regulatory requirements that apply

    Our regulatory services include:

    ●Product evaluation and regulatory strategy preparation

    ●GAP analysis of the existing data and regulatory advice for the generation of additional data or assistance to justify omissions

    EU
    ●Initial assessment of the “novelty” of a food or food ingredient
    ●Novel food consultation procedure
    ●Compile, write and submit novel food dossier
    ●post-submission support

    US

    ●Assessment of GRAS eligibility
    ●GRAS Notice preparation and submission
    ●Food additive pre-petition consultation
    ●Compile, write and submit Food Additives Petition (FAP)

    quality assurance medical

    Quality (QMS)

    Quality System in the FoodTech industry requires an integrated approach, combining quality aspects of biotechnological processes and food products. Gsap is equipped to provide such compliance services as well as the strategy and training to help you improve your quality system, thus mitigating future risks

    Our quality services include:

    ●QA system establishment and maintenance (ISO 9001, ISO 22000, GMP)

    ●Establishing Hazard Analysis & Critical Control Point (HACCP) system (9 CFR
    417 compliant)

    ●Preparation for compliance with FDA Hazard Analysis and Risk-Based
    Preventive Controls (HARPC) requirements

    ●Risk Assessment

    ●Safety Assessment

    quality assurance medical

    Development and Manufacturing

    Gsap’s experts in development and manufacturing of cell-based, biotechnology and pharmaceutical products are well equipped to provide the required support for the FoodTech industry and its unique challenges

    Our Development and Manufacturing services include:

    ●Manufacturing facility planning and validation, including GMP compliance

    ●Consultation on manufacturing process development and scale up

    ●Consultation on bio/analytical assays development and validation

    ●Advise on raw materials selection and qualification

    ●Planning Comparability studies to accommodate process changes

    cro

    Clinical

    With a high level of expertise in clinical affairs, we support wide range of clinical studies, leading to high quality clinical data as per ICH-GCP

    Our clinical services include:

    ● Clinical development strategy

    ● Clinical documents writing (Clinical Protocol, Investigator Brochure, Informed Consent Form)

    ● Clinical documents maintenance and amendment

    ● Clinical Research Organization (CRO) services

    ● Clinical Study Report writing

    pre clinical studies

    Toxological

    Our toxicology experts can help maximize the potential for success by performing product and its components assessment and determining the level of required in-vitro and/or in-vivo testing

    Our toxicological services include:

    ●Toxicological file preparation

    ●Consultation on requirements for in-vitro and/or animal testing

    ●Writing protocols and reports for in-vitro and/or animal testing

    FDA audit

    Audits

    Quality and Regulatory audits are integral part of the FoodTech industry, assuring compliance and readiness for product approval for marketing. Gsap provides a wide range of internal and external audits, as well as client preparation for audits by third parties and regulatory authorities

    Our audit services include:

    ●Internal quality audits for evaluation of the QMS in compliance with ISO 9001, ISO
    22000, cGMPs

    ●External audits of CMOs, CROs, contract laboratories and raw materials suppliers

    ●Preparation for inspections by regulatory authorities (FDA, USDA, iMOH, other)

    Global Submission

    Navigate your product development towards market compliance

    • USA

      FDA

      To facilitate FoodTech product development under FDA oversight, Gsap provides the following services:

      ●Assessment of GRAS eligibility
      ●GRAS Notice preparation and submission
      ●Food Additive pre-Petition consultation
      ●Food Additives Petition (FAP) preparation and submission

    • EUROPE

      To facilitate FoodTech product development under the European Commission
      oversight, Gsap provides the following services:

      ●Assessment of the “novelty” of a food or food ingredient
      ●Novel Food consultation procedure
      ●Novel Food dossier preparation and submission

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