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:
We develop business strategies for companies and pharmaceuticals products.
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)
Preparation of dossiers and regulatory strategy for price registration of medicines and medical devices at CMED / ANVISA.
We develop technical, regulatory and scientific opinions for administrative resources, patents, legal processes, draft laws, public consultations, etc.
Online consulting specialized in regulatory affairs and/ or government affairs at national and international level.
GMP certification, ISO 13485:2016, MDSAP [ANVISA, CE, FDA, etc].
In congresses, events, unions, associations, arguments or defenses in regulatory bodies, Senate, House of Representatives, Comissions, etc.
Personalized training, courses for professionals.
Confidential Regulatory Intelligence mentoring programme for Pharmaceutical Industry Executives.
Get in contact with us at email: firstname.lastname@example.org