The U.S. has become an essential destination for European companies with an international orientation, and many Spanish companies require expert support in the regulation required by the FDA.
At Azierta, we provide specialized FDA regulatory support to European companies interested in marketing their products in the U.S. or that want to be manufacturers adapted to the regulations required by the FDA.
In order to offer a global service that facilitates access to the US market, the Project will cover the following needs:
Analysis of business opportunities
Company Portfolio Analysis, market analysis: needs, trends, competition and growth rates, keys to success, critical strategic issues.
Regulatory strategies, regulatory Review - Drugs, Biological Compounds, Medical Devices, regulatory documentation and support, labelling review, review of promotional material and advertising, relations with Regulatory Agency, CMC Regulation (Chemistry, Manufacturing and Controls).
Manufacturing and Quality
Validations and Qualifications: Equipment, processes, analytical methods, systems and services. Deviations and support of the CAPA System: Identification, Implementation of corrective actions, impact analysis, implementation of preventive measures, evaluation of effectiveness. Compliance: Annual product review, integral product evaluation, change control and Data Integrity performance.
Correction plans: PAI observations, support in response to warnings, 483 response support and preparation for results inspection. External and internal audits. Training: wide range of general and specialized courses to train your staff on FDA regulatory requirements for industry.
Direct representative in USA: administrative expenditure, register, formal communication with FDA.
Toxicological review: specific evaluation of the documentation provided, bibliographic evaluation of components, definition of the proposed test plan, clinical safety monitoring and post-approval pharmacovigilance.
We develop projects adapted to each client to guarantee an expert and efficient service thanks to the knowledge and experience of our professionals.