OUR BUSINESS MODEL

Apphia Laboratories headquartered in Italy, is  dedicated to the development, manufacturing, marketing of premium nutraceutical products.

Our mission is to translate advances in science and technology into effective, scientifically sound Food Supplements, Functional Foods, Nutricosmetics and Medical Devices with the promise to improve health and well-being.

Apphia Laboratories is active in distributing, collaboration, in-licensing, innovation and consulting. We work with local and international distributors wanting to distribute or export our brands. Apphia Laboratories is also a consulting and clinical research provider with a strong focus on natural health products. We support our clients with scientific consulting, regulatory, and clinical expertise. More over we provide Private Label services and offer a wide range of innovative and technological ready-to-market products. We are constantly looking for new ways to strengthen and grow our portfolio with business development activities in the areas of Food Supplements, Functional Foods, Nutricosmetics and Medical Devices.

STRATEGIC INNOVATION

THE NEW NATURAL

Consumers’ demand for sustainable natural products continues to rise globally. Differentiation and speed to market are key. Here, leading innovators rely more than ever on open innovation processes and partnering. To overcome innovation and portfolio gaps, our support includes all aspects of strategy development including specific ready-to-market licensing opportunities. Additionally, we develop or identify commercially viable solutions according to clients’ specific briefs.

STRATEGIC CONSULTING

With a unique combination of technical and regulatory expertise, we provide strategic advice for the best route to market. Our market insights are the basis for tailor-made innovative solutions while bridging consumer needs and regulatory feasibility.

PRODUCT CONCEPT DEVELOPMENT

We offer high added-value solutions from product concept development to launch in different product categories. For the development of new formulations, we work with a comprehensive network of partners.

STRATEGY ASSESSMENT

Winning innovation strategies require skills in multiple disciplines: We provide deep know-how in ingredients, products, health benefits, markets, requirements and trends.

CLAIM SUBSTANTIATION

As a full-service Clinical Research Organization (CRO), we perform highly customized studies covering a broad range of trial types and indications supporting different claim strategies.

REGULATORY EXPERTISE

We guide you through all the regulatory procedures by evaluating your product information while focusing on the legal requirements, be it in the food, herbal drug, or medical device space.

INNOVATION

We combine deep industry expertise with advanced analytics capabilities and consumer-centered approaches to support our clients as they shape their business strategies and drive growth. We create value and enable competitive agility by providing innovation insights, scouting for licensing opportunities, and connecting strategic business partners.

INNOVATION INSIGHTS

Gives overviews on novelties and trends in the natural health market space, featuring innovative solutions. Clients can pick-and-choose from different topics, between new ingredients and finished products, and from various health categories.

MATCHMAKING PLATFORM FOR LICENSING

Our database supports and facilitates licensing opportunities in the consumer healthcare space and accelerates innovation. Comprising various regulatory categories, it includes best-in-class products pre-screened by our team, with a focus on natural health products.

MARKET ANALYSIS

Innovation is a key differentiator to generate value and a strategic competitive advantage for growth. The innovation process requires skill and knowledge in multiple domains. In this area, organizations frequently rely on the external sourcing of missing competences.

MARKET AND COMPETITOR ANALYSIS

We offer market analyses including the evaluation of your business case and project feasibility as well as competitor analysis. Other services include scouting for innovative ingredients and delivery forms, both product-based or technology-driven.

PORTFOLIO ANALYSIS

We analyze product portfolios and support you with licensing opportunities.

CLINICAL RESEARCH

THE ULTIMATE SUBSTANTIATION

Apphia Laboratories  is a full-service Clinical Research Organization (CRO) with a focus on natural health products. We have conducted several clinical trials with moderately active substances as characteristic in most natural products.

We provide support in the development of highly customized study designs covering a broad range of clinical trial types and indications. Full alignment of scientific validity, regulatory requirements, and business needs is the basis for every study performed.

We perform clinical trials from small-scale consumer acceptance studies to multinational, multi-site double-blind RCTs. Investigational products can be food supplements, functional foods, medical devices and cosmetics. Services include planning of clinical studies to substantiate intended claims, identifying the right study population and assessments, successful recruitment due to our own study site including a subject database and network of investigators, and the generation of study documents and integrated reports and publications.

CLINICAL TRIALS

At Apphia Laboratories, our strength lies in our expertise in developing sophisticated study concepts for natural products. Compared to synthetic drugs, natural products are often characterized by small effect sizes and by a delayed onset of the effects. The selection of the study population, the assessment parameters (incl. documentation), the course of study, and the analytical methods have to address these particularities. To reflect different client needs, study purposes, regulatory frameworks and budgets, a&r has implemented a flexible quality system. Each study is assigned to one of three categories which define the level of quality management that is applied. We work in close collaboration with both research and academic partners. Thus, we can offer a broad spectrum of analytical methods such as state of the art diagnostics along with bedded unit capacities.

DEFINING THE SCOPE OF THE PROJECT

  • Understand your needs (e.g. support product commercialization, meet marketing claims, achieve regulatory objectives)
  • Identify key issues
  • Identify all experts required
  • Conduct feasibility research

DESIGNING THE STUDY

  • Evaluate and identify the right study population (e.g. subjects at risk)
  • Select parameters/biomarkers
  • Conduct literature research
  • Develop the study design:
    1. In line with guidelines and regulatory requirements in a cross-functional approach by liaising with regulatory experts in-house
    2. Adapted to the stage of the product life cycle

STUDY SET-UP AND CONDUCT

  • Find the optimal set-up to maximize the success rate
  • Appropriate EC/regulatory submission
  • Refined site selection
  • Most successful recruitment due to our own study site including a subject database and network of investigators committed to natural health products
  • Specific support measures to improve compliance (e.g. alerts, ePRO)

STUDY REPORTING

  • Clinical study report
  • Maximizing the impact
    1. KOL network for expert review
    2. Publications of relevant outcomes in prestigious journals

CLINICAL RESEARCH CONSULTING

Beyond conducting full service clinical studies, we offer a broad variety of customized consulting services by highly experienced subject matter experts.

MAIN AREAS:

  • Development/review of clinical development plan/study documents
  • Support with selection/oversight of trial execution partner
  • Study setup support
  • Training

DEVELOPMENT/REVIEW OF KEY STUDY DOCUMENTS

  • Study synopsis/protocol – refined for evaluation of effects of natural products
  • Statistical analysis plan
  • Statistical analysis report
  • Clinical study report
  • In line with study specific requirements (e.g. ICH guidelines, ISO norm, EFSA guidances)

Apphia Laboratories S.r.l.

Via Casilina Sud 69/E, 03013 Ferentino (FR), Italy

Email: apphia@apphialabs.com

Tel: +39 0775 1831004

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