Our Main Services:

Regulatory Intelligence

We develop business strategies for companies and pharmaceuticals products.

Advisory Board

We act as advisors in public and private companies.

Legalization of companies

We carry out all the steps for legalization of importers, exporters, manufacturers of API, medicines, medical devices, food, cosmetics, etc.

Product registration (MHA)

Preparation of dossiers for medicines, medical devices, cosmetics and food and submission in different regulatory agencies (ANVISA, EMA, CE, FDA, PMDA, LATAM)

Price Registration

Preparation of dossiers and regulatory strategy for price registration of medicines and medical devices at CMED / ANVISA.

Technical Opinions

We develop technical, regulatory and scientific opinions for administrative resources, patents, legal processes, draft laws, public consultations, etc.

Technical-Regulatory Time

Online consulting specialized in regulatory affairs and/ or government affairs at national and international level.

Pre-Inspection/Audits

GMP certification, ISO 13485:2016, MDSAP [ANVISA, CE, FDA, etc].

Presentations

In congresses, events, unions, associations, arguments or defenses in regulatory bodies, Senate, House of Representatives, Comissions, etc.

Education

Personalized training, courses for professionals.

Mentoring Programme

Confidential Regulatory Intelligence mentoring programme for Pharmaceutical Industry Executives.

Legal and technical representation

We can be legal representatives in Europe/Spain and Brazil.

Get in contact with us at email: info@sanitaryintelligence.com