Services

With a customer-focused approach, we are committed to delivering exceptional results and quality service in the shortest time possible.

SANITARY LICENSES

Obtaining New Sanitary Licenses, Renewal, Transfer, Modifications for the operation of all types of establishments, such as: Laboratories, Drugstores, Distributors, Pharmacies, Fractionation, Beauty Salons, Restaurants, Kiosks, among others.
Technical Management and Technical Advice (Regency) of pharmaceutical and related establishments, respectively.
Obtaining registration of companies that handle controlled substances and respective annual forecasts.

Obtaining New Sanitary Registrations for food, pharmaceutical, biological, biotechnological products, supplements, all related products (medical devices, diagnostic reagents, household and hospital hygiene products, cosmetics, phytotherapeutic and zootherapeutic) and dental materials.
Obtaining authorizations for Post-Registration Modifications to the current registration.
Obtaining Renewals with and without changes to sanitary registrations.
Obtaining Advertising Authorization for advertising and promotional materials.
Responsibility of Legal Representation (Holder) for regulatory purposes.
Obtaining Resolutions of non-application of sanitary registration.

Local Responsibility for Pharmacovigilance and/or Technovigilance.
Official submission of Plan, Local Professional, Event Notification, IPS / CIOMS, ICRS, Market Withdrawal, Request and Renewal of Certificates, among others.
Centralized Archive of Source Data, according to SOPs and legal requirements. Monthly Reports: Reconciliation and Literature Search.
Comply with all local regulatory obligations. Notification of changes in local regulation.
Periodic Training.

Responsibility of Legal Representation (Holder) for regulatory purposes.
Conducting self-inspections and regulatory audits.
Technical advice for preparation of files for participation in open contracts and/or tenders.
General technical-regulatory advice and technical talks.
Advice for regional harmonization.

Registration of trademarks and others related to intellectual and industrial property.
Search for the existence and validity of patents.
Incorporation of Companies and Preparation of Formats for Logistic Contracts, Service Agreements, Manufacturing / Conditioning / Distribution Contracts, among others.
Management of the validity of Legal Documents.

Please contact us today to obtain more detailed information about our services and how we can help meet your needs.