Welcome to Documedica
Your Trusted Ally in consulting and services in the pharmaceutical, healthcare, cosmetic and nutraceutical fields.
At Documedica, our mission is clear: to provide cutting-edge solutions and high-quality services in consulting and manufacturing.
Events
AFI
Events
CPhI Frankfurt
Case History
Silverplug®
With years of experience and a team of highly qualified experts, we are dedicated to supporting you at every step of your journey, helping you to achieve and exceed your goals. We are more than just a service provider; we are the partner you can rely on to tackle the most complex challenges and seize the most promising opportunities. Explore our services and discover how we can make a difference for the success and growth of your company. With Documedica by your side, the future of your business is in good hands.
Auditing Services
We offer auditing services to ensure that your company complies with industry standards and regulations. Our qualified auditors provide detailed analyses and personalized recommendations to improve your operations. We plan the entire audit process with you, from pre-audit document analysis and audit program definition to the actual inspection activity and the drafting and evaluation of the audit report.
Third-Party Audits
Documedica regularly conducts GXP, ISO, etc., audits at manufacturers, logistics services, and warehouses active in the pharmaceutical, nutraceutical, and cosmetic sectors. Thanks to our qualified auditors, we can carry out detailed and timely audits, aimed at streamlining the supplier qualification and validation process and maintaining authorization; thus, preserving the quality of services and products brought to market.
Additionally, Documedica has a comprehensive database of Audit Reports that can be made available to companies upon request. Contact us to check the availability of an Audit Report.
Contact us to check the availability of an Audit Report.
Pre Audit
In addition to the essential audits for validation and maintaining authorizations, Documedica also offers Pre-Audit services. These audits are essential for assessing and improving the current status of a manufacturer wishing to obtain a GXP or ISO certificate, adequately preparing them for the audit with the competent authorities.
Internal Audit
The internal audit is a business activity aimed at improving the effectiveness and efficiency of the organization. Documedica offers companies internal auditing services aimed at evaluating and improving the efficiency of the organization and the corporate quality system, ensuring a position of independence and impartiality in reviewing business processes, risk management, and evaluating business procedures.
Regulatory Consulting
Your Expert Guide in Regulatory Compliance
Navigating complex regulatory requirements can be a challenge for any company, but with our regulatory consulting service, you will never be alone in this journey. Our team of experts is dedicated to assisting you in interpreting and applying current regulations, ensuring that your company remains always up-to-date and compliant with required standards. Thanks to our deep understanding of the regulatory landscape, we can identify and minimize potential risks while optimizing your business processes. With our support, you can focus on growing your business, knowing that every regulatory aspect is managed with the utmost expertise and care.
Quality System Consulting
Experts in quality consulting: we elevate your business standards with tailored solutions
Quality is at the heart of everything we do. Our quality consulting service is designed to help your company achieve the highest operational standards. Our consultants work closely with your team to develop and implement customized quality management systems that not only guarantee excellent results but also promote continuous improvement over time. Through a personalized and strategic approach, we help you optimize your processes, reduce inefficiencies, and ensure that every product or service provided meets your customers' expectations and industry regulations. With our support, you can turn quality management into a true competitive advantage for your company.
Product Consulting
Expert consulting for the development of innovative products, from concept to realization.
Bringing a product to market is a complex journey, but with our Product Consulting service, every phase becomes easier and more secure.
We are by your side from research and development to commercialization, ensuring that every step is managed with the utmost expertise and precision. Our team of experts guides you through the product development process, ensuring that all regulations and compliance requirements are met. Additionally, we support you in defining launch strategies to ensure that your product not only reaches the market but does so successfully.
With our consulting, you can focus on innovation and growth, while we take care of transforming your ideas into winning products.
CRO and Laboratory
Customized analytical solutions and CRO for limitless innovation
Lab Analysis
We offer dedicated laboratory analysis services specific to GLP (Good Laboratory Practice) guidelines. Our team of experts ensures maximum quality and reliability in the data, essential for the success of your research and development. We specialize in batch releases, PSD analysis, stability studies (climatic chambers), microbiological analysis, and much more. With cutting-edge instruments and rigorous compliance standards, we are the ideal partner to ensure that every phase of your project meets the highest regulatory and scientific criteria.
CRO
We offer comprehensive CRO (Contract Research Organization) services designed to support the entire lifecycle of your clinical development. From study design to data management, our expert team ensures tailored solutions that meet the highest scientific and regulatory standards. With a deep understanding of industry dynamics and a flexible approach, we are the ideal partner to accelerate your product's journey from the laboratory to the market, ensuring quality, efficiency, and success at every stage.
R&D and Contract Manufacturing
Documedica has a team of experts and leading industry partners available to successfully tackle all stages of development, certification, and production of Medical Devices, Cosmetics, and Dietary Supplements.
Medical Devices
Quality Production: A Leader in Certified Medical Devices
Being a manufacturer of medical devices is a crucial role in the healthcare sector. It means your company is responsible for the design, production, and marketing of medical products, ensuring their safety, efficacy, and compliance with current regulations.
As an ISO 13485 certified company, Documedica, as a Medical Device Manufacturer, can support you in the development, certification, and market launch of new medical devices.
We guide you step by step in obtaining certification and, if necessary, we can become your manufacturer ourselves.
Dietary Supplements
Documedica is a company specializing in consulting and contract manufacturing of high-quality Dietary Supplements. We offer customized solutions, from formulation to labeling, and packaging.
We use only high-quality raw materials that comply with current regulations to ensure safe and effective products. Documedica offers personalized consulting and support, following rigorous quality control protocols, certified by excellence certifications. We produce with particular attention to nutritional compliance and the pursuit of unique innovative formulas.
Cosmetics
Documedica specializes in contract manufacturing of cosmetics, such as the production of creams, emulsions, and skin care. We provide our know-how to develop high-quality projects and products, creating customized cosmetic lines.
We pay great attention to detail and ensure the safety of a certified production process, even for organic and biological cosmetics.
Documedica offers consulting starting from the development of cosmetic products and the selection of quality raw materials to the finished product (including regulatory consulting for marketing and compiling the PIF).
Events
64° AFI 2025 Symposium
11-13 June - Rimini Conference Centre
We are excited to announce our participation in the 64th AFI 2025 Symposium, which will be held from 11 to 13 June at the Palacongressi di Rimini.
Stand: #60-61
It will be a unique opportunity to meet in person, share ideas and discover the latest innovations in the sector.
We look forward to welcoming you.
Events
CPhI Frankfurt 2025
28-30 October
We are excited to announce our participation at CPHI Frankfurt from 28 to 30 October 2025!
It will be a unique opportunity to meet in person, share ideas and discover the latest innovations in the sector.
We look forward to welcoming you.
Case History
SILVERPLUG®:
PRE-SILVERPLUG® SITUATION
Although implants are subject to strict technical and medical certification protocols, to fill the access channel that connects the prosthetic component to the abutment screw, dentists use materials such as temporary cement, cotton pellets, gutta-percha, Teflon, wax or other types of material.
This type of treatment often leads to peri-implantitis in the patient because there are no certified Devices available on the market to be used as a filling.
CHALLENGE
To develop and certify a Medical Device to support implant companies and dentists in their daily effort to prevent peri-implantitis.
SOLUTION
Documedica provided the inventors with its know-how and resources in the design, development, patent filing, and ultimately the certification of a unique product, playing an active role throughout the entire process.
The company contributed to the formulation of the product, the design, the drafting of the patent and the release of the Technical File of the Medical Device.
RESULTS
A patent for the product was obtained, and the SilverPlug® trademark was registered.
The manufacturer was identified, and the prototyping phase was completed.
The product certification was achieved and later updated to comply with the MDR regulation.
USFDA certification was also obtained.
The product is now marketed in over 20 countries.