Consulting & Strategic Innovation
Let's see how we can drive your success!Our company in Germany, analyze & realize GmbH helps our clients to bridge innovation and portfolio gaps through tailored strategy development, product scouting, and commercialization support.
Our expertise ensures commercially viable solutions aligned with your specific needs.
With deep regulatory, clinical and technical expertise in food and health products, we support clients in various regulatory categories such as food, supplements, FSMPs, OTC drugs (including traditional herbal medicines), and medical devices.
Help needed related to novel foods, health claims, herbal drugs, or medical devices?
Support required in product development or regulatory strategies?
Regulatory consulting
Food products and ingredients
We guide you through regulatory evaluations, application strategies, and technical dossier submissions for:
– novel foods and traditional foods from non-EU countries
– food improvement agents incl. food additives, enzymes & flavourings
– health claims
OTC Drug Products & self-medication products
We offer comprehensive support for the registration and development of herbal medicinal products, including:
– eCTD, CMC, and PSUR documentation
– Risk management planning
– Pharmacological & toxicological expert statements
– Regulatory authority meetings
– Conceptional OTC product development
– Regulatory and medical affairs support
Medical devices & IVD services
– Medical Devices: MDR compliance, regulatory checks, consultation for drug-device combos, Notified Body liaison, Technical Documentation.
– In-Vitro Diagnostics (IVD): IVDR compliance, design & development, manufacturing, testing, CE certification.
Strategic innovation
Strategic consulting
– Product development: End-to-end support from concept to launch with expert partner networks.
– Strategic Market Assessment: for innovative ingredients, health benefits, and trends.
– Claim Substantiation: Tailored clinical studies to optimize your claims strategy, from marketing support to full regulatory compliance.
– Regulatory Expertise: Guidance on compliance for food, herbal drugs, and medical devices.
Innovation & insights services
Trend analysis and novel solutions for natural health product, covering ingredients, finished products, and health indications and scouting for innovative ingredients & technologies.
Market analysis services
– Medical & Competitor analysis: Business case evaluation, feasibility stydues, competitor insights.
– Due diligence: Tailored assessment of regulatory, quality and technical compliance and scientific validity on company or product level
– Portfolio Analysis: Tailored product assessments and scouting opportunities
Cosmetics
– Elaboration of the Product Information File (EU / UK)
– Notification on the EU and UK portal
– Verification of labelling
– Regulatory monitoring
– Regulatory support for ‘borderline’ products, home fragrance products and hazardous substances
