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.
Regulation
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 (QMS)
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
Development and Manufacturing
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
Clinical
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
Toxological
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
Audits
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 submissionEUROPE
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