Integrated solutions
Regulatory & Drug Development
Regulatory strategy, dossiers, CMC and API development.
Data Health supports pharmaceutical companies in building and executing regulatory strategies for Brazil and international markets. We integrate regulatory, CMC, API development, nonclinical and clinical expertise to assess gaps, organize documentation and define the most appropriate development pathway for each product.
Core capabilities
Regulatory intelligence and strategyDossier preparation and review — Modules 1-5IND / NDA / ANDA / IMPD505(b)(2) and hybrid applicationsBiosimilar dossiersDMF revieweCTD conversionCMC strategyAPI developmentNon-clinical supportLifecycle managementDrug-development consulting
Brazil-focused capabilities
Regulatory strategy for ANVISADevelopment and review of dossiers covering Modules 1 to 5Generic, similar, innovative and biosimilar productsAssessment of clinical and bioequivalence study requirementsReview of technical documentation from international partnersAlignment between ANVISA, FDA, EMA and other authority requirementsCMC strategy, API development and DMF revieweCTD conversion and document organizationDevelopment planning and lifecycle management
Discuss Your Regulatory or Development Strategy
Other solutions
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You Don’t Need to Find the Right Global Partner. That’s What We Do.
Tell us what your project requires. Data Health will help identify and structure the capabilities needed to move it forward.