Twelve services, from classification to post-approval.
Organized by your company’s stage: decide before investing, get enabled to reach the market, and sustain compliance after approval. Each page details the scope and the segments where the service comes up most.
Decide
4 servicesBefore investing: a regulatory reading of the product, the business and the operation.
Regulatory Consulting
Analysis, diagnosis, design, planning and execution, by a multidisciplinary team.Where we work most: Pharmaceutical,Medical Devices,Food & Beverage,CosmeticsStrategic Regulatory Planning
A study of the product’s regulated market and a simulation of timelines and investment before the decision to invest.Where we work most: Pharmaceutical,Cosmetics,Food & Beverage,Logistics OperationsRegulatory Due Diligence
Assessment of regulatory liability in acquisitions, mergers and investments.Where we work most: Pharmaceutical,Medical DevicesCorporate Restructuring & M&A
Planned transition of licences, registrations and certificates in mergers, acquisitions, demergers and spin-offs.Where we work most: Pharmaceutical,Medical Devices
Enable
4 servicesAn authorized company and a regularized product, ready to reach the market.
Company Licensing
AFE and AE at ANVISA, establishment registration with MAPA, and licences from health surveillance authorities, the Federal Police, the Army, environmental agencies and municipalities.Where we work most: Pharmaceutical,Logistics Operations,Chemical & Sanitizers,VeterinaryProduct Registration
Classification, dossier and notification or registration of domestic and imported products at ANVISA and MAPA.Where we work most: Medical Devices,Cosmetics,Food & Beverage,Chemical & SanitizersGMP Certifications
Adaptation to Good Practices and preparation for the certification inspection.Where we work most: Pharmaceutical,Medical Devices,Logistics Operations,Chemical & SanitizersCompulsory Certification & Foreign Markets
Liaison with certification bodies under the INMETRO and ANATEL schemes and in other compulsory certifications.Where we work most: Medical Devices
Sustain
4 servicesAfter approval: maintain, update and demonstrate compliance.
Regulatory Management
Deadlines, renewals and ancillary obligations for licences and registrations, followed continuously.Where we work most: Pharmaceutical,Logistics Operations,Veterinary,Chemical & SanitizersPost-Registration Activities
Changes, revalidations, registration certificates and Certificates of Free Sale after approval.Where we work most: Medical Devices,Cosmetics,Veterinary,Chemical & SanitizersQuality Management
Qualification and audit of suppliers and partners, with the records of each assessment.Where we work most: Logistics Operations,CosmeticsIn-Company Training
Tailored programmes on quality, operational routines and training policy.Where we work most: Logistics Operations
Looking for your sector?See all 7 segments
From diagnosis to maintenance, in four stages.
The same method in every project: understand the product, chart the route, steer the process to the authority’s decision and keep everything valid afterwards.
Diagnosis
Deep dive into the product, the operation and the applicable regulatory framework.
Strategy
Route definition: requirements, documentation, deadlines and owners.
Execution
Dossier preparation, filing and dialogue with the regulatory authority.
Approval and maintenance
Follow-through to the decision and post-approval management to keep everything valid.
Not sure which service to start with?
Tell us about the product, the market and your company’s position in the supply chain. We point out the regulatory classification and the first step.