Regulatory Affairs
We support companies in complying with national and international regulations, guiding them through the authorization and registration processes for pharmaceuticals, medical devices, food supplements, and cosmetics.
Pharmacovigilance and Post-Marketing Surveillance
We offer structured pharmacovigilance systems and continuous monitoring, ensuring timely risk management and full regulatory compliance to safeguard patients and healthcare professionals.
Quality Management System
We implement Quality Management Systems (QMS) to optimize business processes, improve traceability, and ensure compliance with regulatory standards in regulated sectors.
Research & Development
We support companies in the development of pharmaceuticals, medical devices, food supplements, and cosmetics by providing scientific and operational consulting from formulation to market launch.
Auditing & Compliance: Assicura la Conformità ai Massimi Standard Normativi
Face inspections with confidence and uphold the highest regulatory standards. We provide support for both internal and external audits, ensuring compliance with international regulations such as: GMP, GDP, GVP e ISO.
The Regulatory Compliance and the certified quality are essential elements for a company’s sustainable growth.
Our team supports organizations in the management and implementation of internal and external audits, prepare the company for regulatory inspection, regulatory audits and compliance strategies.
We work to ensure alignment with the main standards: GMP, GDP, GVP and ISO.
- Preparation for audits and inspections: we support you in planning and managing regulatory checks and site visits.
- Certification support: we guide your company through the compliance process with GMP, GDP, ISO, and GVP standards.
- Internal and external audits: we analyze and optimize processes to ensure compliance with standards.
- Continuous improvement: we develop tailored strategies to make processes more effective and traceable.
- Documentation compliance: we support the drafting, management, and updating of quality documentation.
