The pharmaceutical area is one of the most regulated sectors in the world. Over years we have developed an innovative work methodology considering all the aspects that could impact the success of a business/project. Therefore, we build a personalized technical and regulatory strategy for each client in accordance with the Sanitary legislation of the countries of interest.
For this reason, before presenting a job proposal, we carry out an initial technical meeting to be able to understand the main objectives of our clients and adapt to a better solution.
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.
Get in contact with us at email: info@sanitaryintelligence.com