It’s a company specialized in support and advice for industries of medicines and supplements food.
SERVICES
Due Diligence
Audit of drug product marketing authorization dossiers and/or processes in medications (all regulatory category) and food supplement to verify compliance with the Brazilian legislation and identification of technical and regulatory risks prior to negotiations between the parties.
GAP Analysis
Evaluation of documentation (medice products, food supplement, DMF (DIFA), and etc.) for diagnosis of possible failures and direction of actions to mitigate risks for submission of drug products marketing authorization and variations.
Ongoing Regulatory Support
Multidisciplinary support in the industry’s routine for technical-regulatory impact assessment in change control, strategic discussions, clarification of doubts and representation with the health authority.
Regulatory Assessment and definition of regulatory strategy for drug product lifecycle maintenance and management.
Regulatory Advice
Preparation of technical and regulatory documents.
Outsourcing and allocation of qualified technical professionals, depending on the needs of the organization.
Advice on Deficiency Letter Response
Technical and regulatory assessment and discussion to define a strategy for complying with the requirement for drug product marketing authorization and/or variations, regardless of the regulatory category.
Strategy and Regulatory Intelligence
Support in the definition of technical-regulatory strategies for submission of marketing authorizations and/or variations of drug products in Brazil.
Training
Regulatory training for the application of regulations and specific guidelines in the practice of the pharmaceutical and pharmacochemicals companies.
