Regulatory and Quality Control Services for Pharmaceutical Companies

Sanitary regulation and quality control in the pharmaceutical industry go far beyond obtaining initial licenses.

They represent the structure that allows a company to exist, operate, grow, and remain compliant in highly regulated environments with multiple sanitary, environmental, technical, and administrative requirements, and to succeed in any audit.

ELS Group is your strategic partner in all stages of your structuring and operation, from opening and sanitary regulation to the continuous maintenance of regulatory compliance and quality management systems.

Our approach combines in-depth technical knowledge, strategic understanding of legislation, and the ability to execute with local, national, and international regulatory bodies.

With an international presence and consolidated operations in Europe and Latin America, ELS Group structures regulatory and quality solutions adapted to the operational reality of each pharmaceutical company in 11 geographies.

ELS Group's comprehensive scope of Regulatory and Quality Control solutions for pharmaceutical companies.

Sanitary regulation and quality control for pharmaceutical companies require an integrated business vision capable of simultaneously considering sanitary, environmental, structural, operational, and institutional requirements.

In this context, the ELS Group acts as a technical-strategic partner, supporting pharmaceutical companies in structuring, regulating, maintaining, and continuously adapting their regulatory operations over time.

Our scope of action is integrated, customized, and oriented towards reducing regulatory, operational, and institutional risks, including:

  • Opening and sanitary regulation of the company, with correct classification of activities.
  • Company registration with the Municipal Health Surveillance and the local regulatory body.
  • Company registration with Professional Councils and obtaining Certificates of Technical Responsibility.
  • Assumption of Technical Responsibility by qualified professionals and acting as Legal Representative, when applicable and in accordance with current legislation.
  • Definition, updating, and verification of company size with the regulatory body.
  • Changes to address, company name, legal and technical representative.
  • Operating Permit from the City Hall (low and high risk)
  • Application for AFE – Business Operating Authorization
  • Application for Special Authorization (AE)
  • Issuance of sanitary licenses and authorizations
  • Petition for compliance with inspection requirements and response to notifications.
  • Sanitary Project Development
  • Defining the operational workflow layout, ensuring proper segregation of activities.
  • Guidance on physical adaptations and infrastructure.
  • Mandatory postings, signage, and other legal requirements.
  • Petition for approval of new building
  • Petitioning for permits for renovations, demolition, amnesty, change of use, and regularization of properties.
  • Petition for Occupancy Permit (Certificate of Completion of Works)
  • Petition for AVCB – Fire Department Inspection Certificate
  • Petition for renewal of Fire Safety Certificate (AVCB)
  • Petition for a Civil Police Operating License
  • Preparation of Control Maps for Civil Police and Federal Police
  • Consulting services in Good Distribution and Storage Practices
  • Preparation of Standard Operating Procedures (SOPs)
  • Structuring and maintaining the Quality Management System
  • Supplier auditing and qualification
  • Management of internal audits and inspections
  • Quality Management System Audit
  • Licenses from environmental agencies
  • Working with CETESB
  • LP, LI, LO, CDL, TCA and PCA petition
  • CADRI petition and preparation of the PGRS.
  • IBAMA Registration Certificate
  • IBAMA Federal Technical Registry
  • Petition for Occupancy Permit (Certificate of Completion of Works)
  • Mapas de controle IBAMA
  • Orientações sobre descarte adequado de resíduos
  • Definition and update of CNAE – National Classification of Economic Activities
  • CAE – Registration and Classification of Economic Activities
  • Registration and regularization with local regulatory bodies.
  • Consult your local zoning department.
  • Regulatory intelligence applied to business
  • Updating and monitoring of health legislation
  • Monitoring of protocols in the Municipal Health Surveillance Department
  • Monitoring of protocols at the local regulatory body.
  • Strategic regulatory advice
  • Technical consulting on an hourly basis
  • Mandatory training required by the Health Surveillance Agency.
  • Trademark Registration
  • Expansion or reduction of class or activities

By structuring health regulations and quality control for pharmaceutical companies in an integrated way, the ELS Group ensures alignment between legal, technical, and operational requirements, reducing the risk of fines, shutdowns, and rework.

The result is a more predictable, safe, auditable pharmaceutical operation, better prepared to grow in complex regulatory environments.

Strategic consulting for the pharmaceutical and regulatory industry.

Experts in pharmaceutical consulting, regulatory strategy, and market access to support your company with safety, compliance, and efficiency. Talk to a consultant.

I want to speak to a Specialist

Frequently asked questions about regulation and quality control for pharmaceutical companies.

It is the set of activities that allows a pharmaceutical company to operate in a regular and sustainable manner, meeting applicable health, technical, environmental, and institutional requirements.

This scope includes licenses, authorizations, classifications, technical responsibilities, quality management systems, audits, and continuous compliance maintenance.

Whenever you are starting an operation, changing size or activities, changing address, undergoing inspections, renewing licenses, structuring internal processes, or responding to requirements from regulatory bodies.

In practice, the need begins before the start of operations and continues throughout the life of the company.

The main risks include fines, notifications, operational delays, operating restrictions, loss of licenses, shutdowns, and increased legal and regulatory exposure.

Furthermore, inconsistencies between infrastructure, documentation, and internal processes tend to generate rework and weaken the company’s capacity for growth and expansion.

ELS Group operates internationally, with a presence in 11 countries, offering regulatory and quality support in Europe and Latin America.

The company has specialized local teams that work in an integrated manner and in accordance with the requirements of the regulatory authorities in each region, allowing it to align global strategies with the specific regulatory requirements of each market.