Services provided
Regulatory Affairs
Technical visits by Única’s consultants in order to give specific technical support in a timely and urgent manner.
Assessment of regulatory documents, petitions, or proceedings and delivering of a report covering the identified gaps and the suggested corrective actions.
Única offers different modalities of gap analysis:
1. Petition Gap Analysis: assessment of petitions (registrations, renovations, post-registrations, or requirements compliance).
2. Proceeding Gap Analysis: assessment which covers the full history of a product, encompassing its original registration, renovations, post-registrations, and related actions.
3. Directed Gap Analysis: evaluation of the most critical aspects of a petition or proceedings either selected by the client or suggested by the consultancy.
4. Focused Gap Analysis: verification of documents related to the applicable law and the respective petition checklist or the specific proceedings checklist.
5. Block Gap Analysis: assessment of registration applications when they are divided in blocks. The analysis might be of all the blocks in the application, or of specific blocks selected by the client. The definition of each block may be established by the client or suggested by the consultancy. Such job does not include data crossing among blocks.
6. Gap Analysis 2: assessment of gaps identified in the Petition Gap Analysis report (registrations, renovations, post-registrations, or requirements compliance) and delivering of a new report.
Elaboration of dossiers according to the applicable laws (registrations, renovations, and post-registrations), including or not a petition analysis.
Assessment of petitions, procedures/suits, clarifications, regulatory updating, among other services provided according to the client’s needs and in a specialized and customized support.
Regulatory compliance assessment regarding legal aspects, including: (i) checking of the client’s established routines; (ii) legal documentation (licences/permits, compliance certificates, certificates of good practises in manufacturing); and (iii) regulatory technical documentation by sampling (pilot lots documents, stability studies, analytical methods validation, products registration and renovations, etc.). Such services have to be provided in-company.
Regulatory risk assessments of products or portfolios of products prior to the signing of a contract, acquisition, or joint venture agreement.
Regulatory technical advice regarding the keeping of a product registry status or the feasibility of a product registration.
Organization, planning, and support provided to departments/areas which are in need of technical or managerial knowledge.
Regulatory consultancy provided in company to solve previously identified issues or to execute routine tasks regarding regulatory matters, including documents analysis, proceedings writing, and documents preparation (such as Technical Assessment Legal Advice for Companies or Periodical Product Reviews).
Providing of information to clients regarding ordinances, laws, executive orders, etc. published in the Official Gazette of Brazil, and representations in ANVISA meetings.
Exclusive trainings customised to the client’s needs.
Guidance, analysis, reviews, and/or technical documentation instruction to obtain and/or approve documents such as:
1. Operation Permit: permission for the operation of a business/establishment.
2. Special Permit: permission to carry out activities involving controlled substances/devices/drugs.
3. Sanitary Licence/Operation Licence: a document that certifies the hygienic/sanitary situation of an establishment.
4. Compliance Certificate: a document issued by the professional council certifying technical compliance.
5. Architectural Design: technical document covering the planning, programming, development, assessment, and designing of premises.