Regulatory Affairs Services Provider in Italy
Regulatory Affairs Services in Italy are essential for navigating the complex regulatory landscape of the pharmaceutical and medical device sectors. In Italy, Italian Medicines Agency, or Agenzia Italiana del Farmaco (AIFA) regulates medicinal products and biologics under the Ministry of Health (Ministero della Salute). The marketing authorization applications for medicinal products must be submitted either to AIFA or the European Medicines Agency (EMA), based on the product’s regulatory requirements.
For medical devices, while prior authorization isn’t typically required, it must comply with Legislative Decree 46/1997, undergoing rigorous testing and verification. These devices must also receive a CE mark to enter the market. In May 2022, Regulation (EU) 2017/746 fully replaced the previous Legislative Decree for in vitro diagnostic medical devices. This new legislation includes changes to device classification, increasing the risk classification for many devices. As a result, manufacturers must notify regulatory bodies more frequently to maintain compliance with these updates.
Why Choose DDReg’s Regulatory Consulting Services in Italy?
With a team of skilled Regulatory Consultants for Italy, DDReg offers expert guidance throughout every phase of the regulatory process. Our team assists companies in developing customized strategies to ensure successful regulatory submissions, handle market authorizations, and comply with the latest legislative changes.
We specialize in AIFA Regulatory Consulting to help pharmaceutical and medical device companies achieve compliance with Italian and EU regulations. By leveraging our expertise in Italy regulatory consulting, we help companies navigate complex regulatory pathways efficiently and effectively. With our expert Pharma Regulatory Services in Italy, we ensure that your product launch and post-market activities are seamless, compliant, and efficient.
Our Regulatory Consulting Services In Italy Portfolio Covers
- AIFA Regulatory Consulting
- Regulatory Strategies and Expert Views
- Regultory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizatios
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF Submissions
Our Regulatory Affairs Consulting Services in Italy portfolio covers:
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
