ÚNICA

Única Suporte Científico e Regulatório was set up in June 2005 to establish a new concept in consultancy firms.
Única are a team of highly qualified professionals specialized in sanitary surveillance who abide to the company’s philosophy and work, and our success is due to customised services provided in precise diagnoses in several fields.
The company are based in Porto Alegre and also have agents in  Brasília, totalizing a workforce of over 20 people who contribute with their knowledge and experience to give support to various national and international businesses.
Our ethical commitment and very positive results set us apart and makes us a serious, solid and renowned company.

COMPANY MISSION STATEMENT
“We aim at being the national benchmark in services provision excellence in health surveillance through ethical work, commitment and competence to fully satisfy our clients and personnel.”

SERVICES PORTFOLIO

Única Suporte have a portfolio of over 250 clients in areas related to health services and work with health laws in the various segments regulated by ANVISA – the National Health Surveillance Agency – in Brazil.

Services provided

Company conformity
Única work with instructions, protocols and follow-up related to all the procedures required for licensing, renovation of licenses, alterations and problem solving in Sanitary Licenses, Company Opening Licenses (AFE) and Special Licenses (AE) in local, state and national (ANVISA) sanitary surveillance agencies. We also represent our clients in professional associations and councils such as the CRF (Regional Council of Pharmacy) to regularise technical responsibility issues.

Implementing and Certificating
Única offer customised technical support to plan and implement Good Manufacturing Practices and Good Laboratory Practices. We can help you to structure your Quality Guarantee System bringing manufacturing areas to accepted standards, drawing up or revising documents of quality assurance (SOP, Batch Documents, Manuals and Protocols), improving and validating analytical methods, controlling changes and qualifying suppliers according to national and international statutory requirements.

Product Development
We can assist you in the technical development of your product and its legal classification (ANVISA), supporting the steps definition and management either in an associate laboratory or in your own company. We will also help you find convenient and reliable centers to carry out studies of Pharmaceutical Equivalence, Bioavailability and Clinical Studies.

Product Registering and Post Registering
Única rely on a specialized team experienced with regulation issues, interface management and the various steps in the classification and strategy planning for registering, post registering and license renovation of both national and imported products. We also work with drug description leaflets, labelling and advertising material, subcontracting agreements, manufacturing place registration alterations, follow-up of law and administrative suits and take powers of attorney to liaise with regulatory agencies.

Clinic Tests
We work in tandem with research centers to carry out products safety and efficiency tests, planning and assessing clinic studies protocols, and obtaining statutory approval for clinic tests.

Literature Reviews
Searching and reviewing of national and international literature to prove the safety and efficiency of health products.

Farmacosurveillance
Única provide company support in setting up an internal farmacosurveillance program, fostering the information exchange between Customer Services and Quality Control departments and
bettering the relationship practices with the companies’ customers.

Regulation Auditing
Única help companies to collect all the documents required for regulation purposes as well as for carrying out stability studies, registering and post registering manufacturing processes to define the best strategy and plan for the due corrective measures.

Quality Auditing
Our consultancy defines all the requisites necessary to establish good manufacturing practices (GMP) and good laboratory practices (GLP) regarding, among others: premises, equipment, instruments, ancillary systems, validation studies and quality guarantee system proceedings.

Training
In-company training adequate to each client’s requirements in Pharmaceutical Management, Quality Guarantee, Quality Control, and Regulation Issues.

Risk Assessment
We assess the critical points in the manufacturing process and quality control, analyse the data and trends and develop strategies to ensure trustworthy and safe operations.

Legal Support
Provision of legal support both in law courts and administrative courts, drawing up and reviewing lawsuits, agreements, administrative court appeals, legal counselling and assistance to deal with regulation agencies.

Hazard Analysis Critical Control Point (HACCP)

Única carry out all the necessary studies do establish critical control points in manufacturing, cleaning and sanitization processes necessary to develop safe strategies to control processes and also validation protocols required by good manufacturing practices.