Gruppo FarmaImpresa Services

Our company is able to guarantee a wide range of services, useful to cover the needs of customers at 360 degrees
Over 200 new formulations and 1000 compliance tests per year.
We conduct stability, efficacy and safety testing.
We have dossiers on all our products and can develop new ones dossiers for your formulation.
We provide efficacy data on products derived from our experience and clinical trials.
We offer strategic-regulatory advice on key aspects of commercialization, enabling our client to navigate the complexities of international regulations.
We support the registration and marketing of your products, providing documentation and interface with the relevant authorities.
We support clients in product launch, from providing marketing dossiers to product training for the sales force.
We design and implement visual communication for your brand and products.
We have trademarks on some of our products and patents on some innovative formulations

Research and Development

The R&D department is the partner that catalyzes innovation for the company and your business.

We provide our decades of experience in developing medical devices based on substances, food supplements and dermocosmetics with pharmaceutical rigor and the flexibility you need for the most ambitious and complex projects.

We meet market and technical challenges by investing in researching the most effective and innovative health and wellness solutions in order to deliver you a unique product that meets the most stringent regulatory and quality requirements.

Our main focuses:

  • Study of target market, benchmarks and competitors
  • Formulation and regulatory feasibility study.
  • Research of the most effective functional actives suitable for your target; we define the added value of your product
  • Prototyping and preliminary stability study.
  • Technology transfer and pilot batch implementation for ICH stability studies, clinical trials or panel tests

Regulatory Affairs

Gruppo FarmaImpresa is able to assist customers in implementing all the requirements of the various regulations in force for the corresponding product classes, to support its customers in registering products for proper placing in the territories of interest. Providing for example:

  • Certificates of Free Sale (FSC)
  • Legalized and apostilled documents
  • Certificates of analysis
  • Certificates of composition
  • Certificates of origin
  • Reports on stability studies
  • Technical and scientific documentation upon request

For the medical device field, we are able to offer/support in the following services:

  • Regulatory support in obtaining CE marking
  • Drafting and updating of technical product and quality system documentation according to the ISO 13485 standard for compliance with the New Regulation 2017/745 (MDR)
  • Direct contact with Notified Bodies (NOBs)
  • Management of the Eudamed Database
  • Post-marketing monitoring and vigilance of medical devices
  • Internal and/or external training

For food supplements field, we are able to offer/support in the following services:

  • Feasibility studies for food supplement and related products
  • Label evaluation, notification process, registration as FBO and related services
  • Drafting of scientific technical rationale for food supplements
  • Novel food authorization process at the European Commission
  • Collaboration for import from EU and non-EU countries
  • Collaboration in the preparation of technical and administrative documents for export to the EU and non-EU countries
  • Certificates of Free Sale
  • HACCP and audits
  • Advertising on food supplements and related products
  • Foodvigilance and Phytosurveillance

For dermocosmetics field, we can offer/support in the following services:

  • Feasibility studies and regulatory intelligence for cosmetics
  • Product Information File (PIF) consulting, label evaluation and related services
  • Certificates of Free Sale
  • Quality Management System according to ISO 22716 and audits
  • Cosmetovigilance

Dossier Development

We have dossiers on all our products and can develop dossiers new ones for your formulation, such as:

  • Technical file according to according to European Regulation 2017/745 MDR (Medical Device Regulation)
  • P.I.F (Product Information File) according to European Regulation 1213/2009
  • CTD (Common Technical Dossier)

Marketing Support

Gruppo FarmaImpresa is able to support its clients in supporting the launch and dissemination of the product on the market.

Thanks to decades of experience in the field and highly qualified internal know-how, We are able to support the client by

  • Drafting of dossiers
  • Drafting of product marketing sheets
  • Drafting of rationale for use
  • Drafting of monographs
  • Definition of product claims
  • Advertising strategies most suitable for online/offline promotion and in compliance with current regulations
  • Validation of the most suitable intended use for the chosen reference
  • Training of the client’s sales network in order to present the product to medical staff in all its specifications

Data and Clinical Trials

Many of our products have been evaluated, demonstrating their efficacy and safety with clinical trials; we also design and develop clinical trials for your every need.

We design clinical trials for medical devices certified according to the European Medical Device Regulation (MDR) 2017/745 and constantly collect data from the market to support the safety of our products.

In addition, we operate by managing the development of clinical studies on food supplements thanks to extensive in-house cross-functional expertise in relation to the many actors involved (participating subjects, ethics committees and competent authorities, scientific societies and academia), constantly updating in an interconnected set of increasingly stringent international regulations and guidelines.

We design and implement clinical trials, supporting customers from an idea to implementation to publication of the article in scientific journals.

We are able to offer support with the following services:

  • Hypothesis definition and study design
  • Experimental methodology and clinical protocol
  • Ethics committee forms and submission
  • Identification of the “principal investigator”
  • Training of investigators
  • Scientific article writing and publication

Graphic Design

Clear and effective visual communication is the secret to a brand or product’s success. Gruppo FarmaImpresa supports its customers in the graphic design of the brand and products, thanks to its specific know-how in the field.

We can offer support with the following services:

  • Logo design
  • Corporate identity
  • Packaging design
  • Marketing materials (Infographics, information brochures and gadgets)

Consulting and Certifications

To deal with international markets, it’s important to understand local regulations. We offer strategic-regulatory advice on key aspects of commercialization, enabling our customers to deal with the complexity of international regulations. Regulatory services aim to provide timely answers to solve specific issues, for the following areas of interest:

  • Medical devices based on substances
  • Food supplements and related products
  • Cosmetics

We also support manufacturers in the certification process:

  • Obtaining CE marking, ISO & GMP FOOD certification.
  • Pre-certification audits at manufacturers, workshops, warehouses and various suppliers (domestic and foreign)
  • On-site or remote assistance during certification audits and subsequent resolution of nonconformities
  • Direct contact with Notified Bodies (ON)

Trademarks and Patents

We support our clients in identifying the best strategy for intellectual property protection by accompanying them in the process of preparing and filing applications for trademarks and patents.

In order to protect our intellectual property we have trademarks on some of our products and patents on some innovative formulations. (link to our technologies).