LB Quality Process
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Regulatory Intelligence and Affairs

Interpretation of requirements, regulatory authorization of products and companies, and support for interactions with health authorities.

Illustrative editorial image: Regulatory Intelligence and Affairs
Our approach

From regulatory classification
to regulatory strategy.

Applying a regulatory requirement depends on understanding its scope, legal status, purpose and operational impact. LB Quality Process supports interpretation and action planning for the specific context of each company and product.

Technical scope

How we can help.

Company and product authorizations

  • Regulatory strategies for medicines, medical devices, cosmetics, sanitizing products, food supplements and medicinal cannabis products, subject to the applicable classification and jurisdiction
  • Operating authorizations and health licensing procedures
  • Labeling and package insert requirements, where applicable
  • Planning regulatory submissions, responding to agency requests and technical support for registration hosting arrangements where legally and contractually applicable

Health authority interactions and technical responses

  • Technical preparation of responses to regulatory requests and notices
  • Development and follow-up of remediation plans
  • Support for technical meetings with ANVISA and state or municipal health authorities in Brazil
  • Assessment of the regulatory impact of changes to products, facilities and processes

Evidence and specialist assessments

  • Critical assessment of stability, clinical and preclinical studies, where relevant to the product category and regulatory purpose
  • Regulatory audits and gap assessments
  • Assessment of domestic and cross-border operations and regulatory interfaces with quality control, clinical and preclinical research laboratories
  • Organization of technical dossiers and regulatory documentation

Services depend on the applicable regulatory framework and the agreed scope. Certificates and official approvals, where relevant, can only be issued by the competent authorities or accredited bodies.

Explore more

Related services.

QUALITY

Quality Management System (QMS)

PROCESSES

Engineering and Industrial Processes

QUALITY + PROCESSES

Qualification and Validation

Shall we review your situation?

Describing your technical need is the first step in identifying requirements, priorities and scope.

Talk to LB Quality Process