Regulatory Affairs Services and
Quality Control of pharmaceutical products

Who We Are

ELS Group brings together a team of highly specialized professionals with proven experience in regulatory frameworks and compliance in the pharmaceutical sector. We position ourselves as a strategic partner from administration to technical management, ensuring rigor, consistency, and predictability in driving critical decisions and mitigating regulatory risk.

Our company provides comprehensive support in regulatory affairs, Quality Control (QC), and pharmacovigilance. This support aims to reduce regulatory risk and enhance the success of commercial operations in strategically selected markets by defining a regulatory strategy and the most appropriate authorization pathway. The authorization process includes the structuring and detailed review of the Marketing Authorization application and its subsequent commercialization. Post-marketing lifecycle management, including variations, renewals, and ongoing compliance maintenance, is conducted rigorously and consistently. We also ensure compliance in QC, as well as drug labeling and information, guaranteeing adherence to regulatory safety obligations through robust documentation, traceability, and deadline management standards in a highly regulated environment.

We have a presence in 11 countries, operating directly in Europe and Latin America, with a special focus on Portugal and Brazil, where we have an operational presence. We operate in complex and highly regulated environments, ensuring technical consistency across jurisdictions and continuous alignment with national authorities.

ELS Group is present at every stage of the product lifecycle, from market access to the post-marketing phase. In this context, important decisions are made regarding positioning and continuity in strategic markets, maintaining authorizations and marketing conditions, preventing supply disruptions, and, above all, reducing the risk of non-compliance. These measures have a direct impact on operations and commercial performance. The team supports, with the same level of rigor, every stakeholder in the pharmaceutical value chain – manufacturers, distributors, importers/exporters, quality control laboratories, and logistics partners – as well as all operators who, in practice, ensure product continuity and compliance up to market.

Full scope of Regulatory Affairs and Quality Control Services for pharmaceutical products.

Pharmaceutical product registration
  • Generic, Similar, New and Innovative Medicines
Excipient or material used in its preparation
Packaging material
Preparation, review, and submission of technical dossiers to the local regulatory body.
  • Preparation, review, and submission of the AIM technical dossier.
  • National AIM procedure
  • AIM mutual recognition procedure
  • Decentralized AIM Procedure (DCP)
  • Centralized AIM procedure
Conversion of AIM dossiers from NTA format to eCTD.
Renewal of drug and active pharmaceutical ingredient (API) registration
Cancellation of registration of an Active Pharmaceutical Ingredient.
Transfer of ownership of drug registration
Transfer of ownership of registration of Active Pharmaceutical Ingredients
Post-registration changes and regulatory lifecycle management Risk Classification Analysis, determining the correct classification of the drug with the local regulatory authority.
Drafting regulatory opinions and clarifying technical questions Strategic regulatory support and regulatory impact assessment
Gap Analysis of the technical documentation
Preparation of feasibility reports for the regulatory approval of medicines and active pharmaceutical ingredients (APIs).
Authorization for the purchase of medicines subject to special control (AMC)
Issuance of sanitary licenses and authorizations
Import and export of medicines and active pharmaceutical ingredients (APIs).
  • Legal representative
  • Technical representation
  • Pharmacovigilance / QPPV
  • QP
  • Lot release
  • Authorization to conduct clinical trials
  • Pharmacovigilance of clinical trials
  • Request for authorization for compassionate use, expanded access, and post-study drug supply.
  • Establishing specific indications for treatment.
  • Scientific and regulatory writing
  • Preparation of technical reports
  • Description of dosage, frequency and route of administration.
  • Clarification of beneficial safety and efficacy claims for patients and physicians.
  • Good Manufacturing Practices (GMP) Certification for Medicines
  • Good Manufacturing Practices Certification for Active Pharmaceutical Ingredients
  • Certification of Good Distribution and Storage Practices for Medicines
  • Certification of Good Distribution and Storage Practices for Active Pharmaceutical Ingredients
  • Services for Chemistry, Manufacturing and Controls (CMC)
  • Toxicological services and risk assessment
  • Equivalence assessment
  • Pharmacovigilance of medicines
  • Notification of Adverse Drug Reactions (ADRs)
  • Periodic Safety Reports (PSR)
  • Periodic benefit-risk assessment report
Qualified Person (QP) Services and Batch Release Reporting on the reactivation of drug manufacturing or importation.
  • Developing market access strategies
  • Health economics evaluation and outcomes research (HEOR)
Customized technical and regulatory training

By concentrating drug regulation and quality control into a single strategy, ELS Group enables pharmaceutical companies to operate with greater regulatory predictability, reduce technical and regulatory risks, and sustain operations in multiple markets simultaneously.

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.

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Frequently asked questions about drug regulation and quality control.

These are services that ensure that medicines meet the legal, technical and quality requirements imposed by health authorities, from development to post-market.

Whenever it operates in regulated markets, develops or markets medicines, it undergoes audits, seeks certifications, or expands operations internationally.

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

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

Yes. The group has advanced experience in implementing and integrating ISO 13485-based systems within broader regulatory ecosystems, strengthening governance, traceability, and quality.

Yes. We operate in pharmacovigilance as an integrated part of drug regulation and quality control, ensuring continuous compliance in the post-market phase.