YOUR ENTRY INTO THE BRAZILIAN MARKET
If your company is considering the insertion of your portfolio and pipeline of products in the high potential Life Sciences Market represented by the Brazilian Country, Zalika Farmacêutica must be your local partner in Brazil!
Conceiving tailored projects, Zalika will support your company in all stages of the Market Entry Strategy.
Strategizing a concrete Entry Process, Zalika will take care of the activities which are part of our main core Business.
Our Strategic Entry Process
At Zalika, we specialize in guiding our partners through every stage of the Entry Process into the Brazilian pharmaceutical market. From regulatory compliance to market strategy and commercialization, our comprehensive support ensures a safe, efficient, and cost-effective path to success.
Explore the step-by-step flow of our core services below:
Entry Strategy Support
We define a customized, regulatory-compliant and cost-effective strategy for each partner.GMP Package Preparation
From pre-audit to official ANVISA audit, we ensure complete GMP compliance.Finished Dosage Dossier Elaboration
Our team prepares comprehensive documentation for finished pharmaceutical products.- API Dossier Elaboration
We compile and submit detailed API documentation in accordance with ANVISA standards. - Full Product Registration & Implementation
We manage the complete registration process and subsequent implementation including Quality Control and Pharmacovigilance. CMED/Pricing Dossier
Required for all new entities, post-Market Authorization (MA) to define commercial pricing. Zalika prepares and submits CMED-specific dossiers.CONITEC Dossier for SUS Integration
Essential for products seeking inclusion in the public healthcare system (SUS). Zalika supports full dossier preparation for CONITEC.Clinical Trial Evaluation and Guidance
We assess and support clinical study designs and documentation for Brazilian regulatory approval.Market Evaluation and Business Plan support
We analyze potential market dynamics and assist in shaping effective business plans.Alliances and Commercialization
We facilitate strategic partnerships and commercial launch initiatives to maximize market reach.Additional Note:
CMED (Chamber of Drug Market Regulation) is mandatory for all new products post Market Authorization.
CONITEC (National Commission for the Incorporation of Technologies into the Unified Health System) is necessary for products that will be included in the SUS (Unified Health System). Zalika provides full expertise and dossier preparation for both processes.
Zalika Farmacêutica: SURPASSING FRONTIERS AND BRINGING NEW BUSINESS INTO THE BRAZILIAN COUNTRY
DID YOU KNOW?
Zalika Farmacêutica is committed to your journey in the Brazilian Market.
The entire process of culture and mindset adaptation along with the required investments will be less impactful even at a distance. Zalika’s expertise in the segment will allows you to have autonomy with the security that regulations are being observed and actions to wards the regulatory bodies are being executed with agility and compliance.
Zalika’s “satellite”operating model, will enable your Company to successfully achieve results in the prominent Brazilian Market.
