Medical devices & pharmaceuticals
COSM&TIC ASSIST Medical devices & pharmaceuticals
Quality and compliance with current regulations is fundamental, and for this reason, Cosm&Tic Assist has chosen to offer tailored consultancy for medical devices and drugs (pharmaceutical and healthcare products) to support your company. With its ample experience in the sector, our company will provide you with a wide range of services.
This way, your company will be able to count on a quality production system in compliance with the regulations in force. Request a quote on assistance services for medical devices and healthcare products by sending us an email or by filling out the appropriate form.
Exclusive assistance
An expert in the field of medical devices and drugs, Cosm&Tic Assist is available to provide your company with exclusive and tailored advice.
Our services are mainly aimed at companies in the medical device and pharmaceutical sector, and concern consultancy regarding regulations and standards, quality, marketing and communications and international import&export.
Quality and compliance with current regulations is fundamental, and for this reason, Cosm&Tic Assist has chosen to offer tailored consultancy for medical devices and drugs (pharmaceutical and healthcare products) to support your company. With its ample experience in the sector, our company will provide you with a wide range of services.
This way, your company will be able to count on a quality production system in compliance with the regulations in force. Request a quote on assistance services for medical devices and healthcare products by sending us an email or by filling out the appropriate form.
Exclusive assistance
An expert in the field of medical devices and drugs, Cosm&Tic Assist is available to provide your company with exclusive and tailored advice.
Our services are mainly aimed at companies in the medical device and pharmaceutical sector, and concern consultancy regarding regulations and standards, quality, marketing and communications and international import&export.
Services for medical devices and pharmaceuticals:
Medical device regulatory
Manufacturer/authorised representative, technical file, person responsible for legislation, certification, notification, Medical Devices Surveillance and Vigilance, Eco-labelling/Environmental labelling (for europe markets). International Regulatory Affairs (Export/Certifications) : EU, UK, USA, CHINA, CANADA, EMIRATES and other states.
Pharmaceutical regulatory
Marketing authorisation, dossier, CTD/e-CTD, summary of product characteristics, package leaflet, IA/IB/II variations, pharmaceutical product certificate, assistance and compliance, Pharmacovigilance. International Regulatory Affairs (Export/Certifications) : EU, UK, USA, CHINA, CANADA, EMIRATES and other states
GMP Quality Assistance for Medical Devices & Pharmaceuticals
Auditing; certification assistance (Medical Devices 13485); personalised training courses; in-house staff training in Italy and Europe.
Auditing and assistance in Pharmaceuticals fields: GMP audits for the benefit of producers of Active Substances (APIs), Intermediates, Raw Materials, Excipients, Finished Product in Italy, Europe, China, India and the rest of the world; audit activities (second part, qualification and periodic evaluation of suppliers, customer specifications, verification of product conformity, supply chain);Other iso: ISO 14001, ISO 50001, ISO 45001, ISO 27001, ISO 22301, ISO 37001, SA 8000, PEFC-ITA-1002, FSC-STD 40-004, UNI PDR 125, UNI 30415, MOCG 231
Legal advice
National Contracts (Sales, Distribution, Production, etc.)
International Contracts (Sales, Distribution, Production, etc.)
National and International Legal Support
Expert Witness Services (as a Party-Appointed Technical Consultant)
Patents and Trademarks Consultancy
Customs Consultancy
Import and Export Customs Consultancy
Customs Operations
Domestic Logistics
International logistics
Worldwide Shipping Support (by sea, land, and air)
Management
Organization management: structure, planning, and management control
Strategic management: analysis and strategic planning
Development management: business development and enhancement
Marketing
Company surveys and customer experience analysis; development of national and international marketing and communication strategies; digital consulting (website, e.commerce and social media); video editors and photo shooting; content creator and copywriter; graphic design; brand identity, strategy and reputation; total or partial rebranding; expert advice service (reviews and recommendations); beauty influencer service (posts, reels, stories); scientific marketing manager service; communication & marketing courses.
International
International taxes, international projects, contracts and international trade, export check-up (1° & 2° level), drafting or operational methodical support to the export plan company, network & tools for national and international business, TEM (Temporary Export Manager) and/or DEM (Digital Export Manager) services, ad hoc consulting and market surveys for export and international plan, worldwide regulatory compliance, patents & trademarks Consulting
Sustainability
SUSTAINABILITY
LCA – (Life Cycle Assessment); Sustainability Reporting (CSRD); EPD – Environmental Product Declaration; Carbon Footprint (Product and Organization); Green Claims (Assessment and Verification)
INNOVATION
Configuration and introduction of integrated information systems – ERP – MES – Big Data Platform – Business Intelligence – Artificial Intelligence; Open Innovation and Cross Fertilization to encourage the birth of innovative ideas; Complete configuration of projects to maximize results
Smart
Business Incubator servizi: incubation, mentoring e networking
Business Accelerator servizi: training, matching e scale-up