Feed Additives, Feed Materials, Compound Feed & Dietetic Feed

Do you have a new animal health product? Are you confused about what product category your product belongs to? Do you struggle to identify what you need for the feed additive dossier completion and submission? Have you received the request for supplementary information and don’t know how to handle it? Need help with the complexity of regulatory requirements and compliance?

I am here to help and support you on your journey to place or maintain your product on the market.

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Feed additives defined as per Regulation EC No. 1831/2003 and 429/2008

  • Technological (preservatives, antioxidants, emulsifiers, stabilizers, thickeners, gelling agents, binders, substances for control of radionuclides, anti-caking agents, acidity regulators, silage additives & denaturants)
  • Sensory (colorants & flavorings)
  • Nutritional (vitamins, pro-vitamins, trace elements, amino acids, urea, etc.)
  • Zootechnical (digestibility enhancers – enzymes, gut flora stabilizers – probiotics, additives favorably affecting the environment, other zootechnical additives – performance enhancers, etc.)
  • Coccidiostats & histomonats

Feed materials & compound feed

Dietetic feed – feed for the particular nutritional purpose (PARNUTS)

chicken

OFFERED SERVICES

  • Regulatory & strategic advice
  • Product & business development
  • Requirements assessment, budget planning & timelines
  • A regulatory road map, product assessment & legal status
  • Data audits, gap analysis & regulatory compliance
  • Study design & statistics
  • Study monitoring
  • Protocol & report writing
  • Literature search
  • Preparation & submission of dossiers (EC/EFSA, GRAS, FAP, AAFCO)
  • FSMA & EFSA compliance
  • Renewals & species extensions
  • Assistance with post-submission questions (SIn, clock-stop)
  • Managing communication with the relevant authorities (EC, EFSA, EURL, FDA)
  • Creating & revision of labels & promotional materials
  • Technical & publication writing
  • Customized training & workshops

Food Enzymes, Food Additives & Flavors

Do you have a new enzyme, food additive, or flavor? Want to add a new use or specification to your existing one? Not sure where to start or what regulatory requirements to follow? Have you received the request for supplementary information and don’t know how to handle it?

I am here to help and support you on your journey to place and maintain your product on the market.

spices

OFFERED SERVICES

  • Regulatory road map, product & legal status assessment
  • Data evaluation, GAP analysis & regulatory compliance
  • Advice & assistance with data generation (study designs, study monitoring, protocol & report writing)
  • Preparation & submission of food enzyme, food additive & flavouring technical dossiers
  • Assistance with post-submission questions
food

NOVEL FOOD

Do you have a new food or food ingredient? Not sure if it classifies as Novel Food and want to commercialize it? Don’t know where to start or how to proceed with Novel Food application? Have you received the request for supplementary information and don’t know how to handle it?

I am here to help and support you on your journey to place your product on the market.

OFFERED SERVICES

  • The regulatory road map, ingredient novelty assessment & legal status
  • Data audit, GAP analysis & regulatory compliance
  • Advice & support with data generation (study designs, study monitoring, protocol & report writing)
  • Preparation & submission of Novel Food dossier as per Regulation No. 2015/2283
  • Assistance with post-submission questions

HEALTH CLAIMS

Want to make a health claim as part of your marketing campaign? Not sure what health claims can you make or if you have sufficient scientific evidence supporting your claim? Want to register a new health claim and don’t know where to start?

I am here to help and support you on your journey to place your product on the market.

OFFERED SERVICES

  • Compliance check with health claims & labeling
  • Clinical studies assessment
  • Literature reviews
  • Preparation & submission of health claim applications
  • Assistance with post-submission questions
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FOOD SUPPLEMENTS

Do you have a new food supplement product? Not sure about the permitted claim and maximum limits? Need help with the complexity of regulatory requirements and compliance?

I am here to help and support you on your journey to place or maintain your product on the market.

OFFERED SERVICES

  • Legal status verification
  • Claim assessment
  • Label compliance review as per Regulation No. 1169/2011
  • Notification process support
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COSMETICS

Have a new cosmetic product or ingredient? Not sure about claims you can make and label content? Want to register a new UV filter, preservative, or colorant and don’t know where to start?

I am here to help and support you on your journey to place or maintain your product on the market.

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OFFERED SERVICES

  • Regulatory & strategic advice
  • Requirements assessment, budget planning & timelines
  • The regulatory road map, product classification & legal status
  • Labeling & claims
  • Preparation of cosmetic dossier as per Regulation EC No. 1223/2009
  • Toxicological evaluation & safety assessment
  • Product information file
  • CPNP notification
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Veterinary medicinal product

  • Pharmaceuticals
  • Biotech
  • Innovated products
  • Novel therapies
  • MUMs (minor use -minor species)

OFFERED SERVICES

  • Regulatory & strategic advice
  • Product development & business development
  • Requirements assessment, budget planning & timelines
  • The regulatory road map, product assessment & legal status
  • Data audits, GAP analysis & regulatory compliance
  • Literature search
  • SME and MUM applications
  • Communication with regulatory authorities:
    1. An innovation Taskforce (ITF),
    2. Scientific Advice (SA),
    3. Pre-submission meetings,
    4. Consultation with national authorities
  • Expert reports
  • Preparation for agency meetings (ITF, SA, etc.) & briefing packages
  • Preparation & submission of marketing authorization dossiers
  • Assistance with a post-submission response to questions
  • Life cycle management (modification, variation)