Research and Development Services for the Pharmaceutical Industry

Strategy, science, and execution to transform innovation into viable and regulated products in Europe and Latin America.

Research and Development is the cornerstone of innovation in the pharmaceutical, medical device, cosmetics, supplement, food, and medicinal cannabis industries.

More than just creating new products, Research and Development services involve technical, scientific, and regulatory decisions that determine whether an innovation will be viable, safe, effective, and scalable in regulated markets.

ELS Group operates in Research and Development with an international, multidisciplinary, and decision-oriented approach, supporting companies from product conception to its technical, regulatory, and commercial validation.

Stages of the Research and Development process at ELS Group

The ELS Group’s Research and Development process is structured to ensure that every technical decision made in the initial phases is sustainable from a scientific, regulatory, productive, and strategic point of view.

The stages are not treated as isolated activities, but as interdependent parts of the same development system.

1

The design phase defines the technical and strategic foundations of the product, in which the concept, purpose, target audience, initial regulatory framework, and technical requirements that will guide the entire development are evaluated.

2

Ingredients, concentrations, interactions, initial stability, and compatibility with the intended use are evaluated, avoiding choices that could create future barriers to registration or production.

3

At this stage, the analytical methods necessary to guarantee the quality, safety, and consistency of the product are defined and validated.

4

The definition of packaging considers not only functional and commercial aspects, but also regulatory requirements, stability, product protection, and labeling compliance.

5

Technical, regulatory, production, and safety risks are identified, assessed, and mitigated, ensuring greater predictability and reducing the likelihood of critical failures throughout the product lifecycle.

6

Stability studies evaluate the behavior of a product over time, under different environmental conditions. This data is fundamental for defining shelf life, storage conditions, and for supporting technical dossiers and regulatory registrations.

7

Validating the production process ensures that the product can be manufactured consistently, in a controlled manner, and in accordance with applicable quality standards.

8

Preclinical trials evaluate safety and performance aspects before human exposure, where applicable.

9

In the clinical phase, the focus is on generating robust scientific evidence regarding safety, efficacy, and performance.

10

ELS Group operates in an integrated manner to identify protectable assets, support patentability strategies, and align technical development with legal protection.

11

This approach avoids rework, anticipates requirements from authorities, and ensures that the product is prepared to safely advance to the registration, production, and marketing phases.

Research and Development for Medical Devices

Research and Development for Medical Devices at ELS Group is structured to support manufacturers and technology holders throughout the entire clinical, pre-clinical, and post-commercialization development cycle, ensuring scientific, regulatory, and strategic alignment from the earliest stages.

Medical Device Testing Projects and Operations

Medical device testing projects and operations require rigorous planning, multidisciplinary coordination, and execution aligned with international regulatory requirements.

  • The role includes support in:
  • Strategy and management of pre-clinical and post-clinical studies, ensuring alignment with MDR, local authorities and notified bodies.
  • Medical writing and translation, ensuring technical consistency and document compliance.
  • Preparation of the Clinical Assessment Report (CAR), integrating clinical data, scientific literature, and real-world evidence.
  • Preclinical studies and design in animal models, when applicable.
  • Clinical trials, from planning to execution and analysis.
  • Specialized scientific consulting to support decision-making.
  • Design and management of Real World Evidence studies, strengthening the clinical and regulatory support for the device.
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Medical Device Surveillance

Surveillance is a critical component of ongoing medical device research and development, especially in the post-marketing context and in maintaining regulatory compliance. The ELS Group offers a structured and integrated approach to surveillance.

  • Specialized consulting in medical devices and surveillance project management, in accordance with current regulatory guidelines.
  • Establishing and overseeing appropriate contractual agreements with partners and stakeholders.
  • Security data management and administration of global security databases.
  • Assessment, monitoring, and management of incidents and adverse events associated with medical devices.
  • Preparation and submission of Medical Device Surveillance Reports
  • Ongoing medical assessment, including research and literature review.
  • Appointment and support of the Person Responsible for Regulatory Compliance (PRRC)
  • Preparation of periodic reports, such as DSUR, PSUR, PBRER and equivalent documents.
  • Audits and pre-inspection consultations, preparing the manufacturer for interactions with authorities and notified bodies.
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Pre-Clinical Consulting Services

Defining an appropriate preclinical strategy is crucial for the success of subsequent clinical and regulatory phases.

  • The ELS Group's non-clinical regulatory team works to develop robust pre-clinical plans aligned with the technical and legal requirements of key markets. Services include:
  • Integrated assessment of technical data, encompassing chemical, manufacturing, pre-clinical, and clinical information.
  • Determining the most appropriate regulatory procedure and legal framework for the device.
  • Defining ideal submission and archiving strategies
  • Structured communication with regulatory authorities, facilitating compliance with requirements.
  • Identification and management of external specialists and resources, when necessary.
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Clinical Consulting Services

The ELS Group’s clinical consulting area is dedicated to the design and execution of comprehensive clinical development programs for medical devices, focusing on risk reduction and maximizing regulatory and clinical success.

  • The multidisciplinary team, composed of physicians, biostatisticians, and clinical scientists, works to develop consistent and sustainable clinical strategies. Services include:
  • Integrated product development plans with a multifunctional approach.
  • Definition of minimum target product profiles (TPP) and respective clinical plans.
  • Design and planning of clinical trials aligned with regulatory objectives.
  • Strategies involving biomarkers and complementary diagnostics
  • Development of global and regional regulatory strategies
  • Support for the development of medical devices in complex clinical settings.
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Research and Development for Medicines

Research and Development for medicines at ELS Group is structured to support pharmaceutical companies from the initial conception phases to advanced clinical stages and preparation for registration, ensuring integration between science, quality, manufacturing, and regulatory strategy.

ELS Group’s work goes beyond isolated technical development. The focus is on building sustainable development programs capable of meeting international regulatory requirements, reducing technical risks, and accelerating market access.

Product Design and Development

ELS Group has a solid track record in developing a wide range of pharmaceutical dosage forms and routes of administration, tailoring each project to the active ingredient characteristics, target market, and applicable regulatory requirements.

  • The scope of practice includes medications based on:
  • Substances derived from plants and extracts
  • Chemical and semi-synthetic substances
  • Biological and biotechnological products
  • Technical support includes the structured definition of development strategies with special attention to quality by design. In this context, the services include:
  • Selection of critical starting materials and definition of Good Manufacturing Practices (GMP) requirements in accordance with applicable guidelines.
  • Identification and definition of critical quality attributes (CQAs) of pharmaceutical substances.
  • Development of formulation programs and manufacturing processes, including technical supervision and final review of results.
  • Planning quality design and defining the design space.
  • Development and management of analytical programs, including protocol review and validation reports.
  • Production transfers and analytical methods, including on-site technical support.
  • Selection of packaging materials and medical devices associated with drug administration.
  • Design and validation of processes, including scale-up.
  • Planning and execution of stability programs, in accordance with ICH guidelines and regional requirements, also considering the supply chain.
  • Definition of requirements for the manufacture, analysis and distribution of Investigational Medicinal Products (IMP)
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Early Stage and Late Stage Services

ELS Group offers ongoing support throughout the entire drug lifecycle, from early development stages to late-stage and post-authorization maintenance.

  • These services are structured to ensure technical consistency, risk management, and regulatory compliance in complex and multi-jurisdictional environments. The scope of work includes, among other things:
  • Technical consulting and project management for development projects, in alignment with current regulatory guidelines.
  • Establishing and overseeing contractual agreements with partners and suppliers.
  • Data security management and maintenance of global databases.
  • Assessment and monitoring of adverse events and safety signals.
  • Preparation and submission of regulatory safety reports, including DSUR, PSUR, PBRER and related documents.
  • Ongoing medical assessment, with structured research and literature review.
  • Planning and executing pre-inspection audits and consultations, preparing the project for interactions with regulatory authorities.
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Pre-Clinical Consulting Services

Developing a solid pre-clinical plan is crucial for the success of subsequent clinical and regulatory phases.

  • The ELS Group's non-clinical regulatory team works in an integrated manner to define strategies that support the transition from non-clinical to clinical development. Services include:
  • Detailed evaluation of technical data, encompassing chemical, manufacturing, pre-clinical, and clinical information.
  • Defining the most appropriate regulatory procedure and legal framework for the drug.
  • Proposal of ideal submission and archiving strategies
  • Structured technical communication with regulatory authorities, facilitating regulatory alignment.
  • Identification, coordination, and management of external specialists and technical resources, when necessary.
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Clinical Consulting Services

The ELS Group’s clinical development team specializes in designing and executing comprehensive clinical programs focused on risk reduction and maximizing regulatory and scientific success.

  • With a multidisciplinary approach involving physicians, biostatisticians, and clinical scientists, the ELS Group supports critical decisions throughout clinical development. Services include:
  • Developing integrated product development plans with a multifunctional approach.
  • Definition of minimum target product profiles (TPP) and respective clinical plans.
  • Design and planning of clinical trials aligned with scientific and regulatory objectives.
  • Development of strategies involving biomarkers and complementary diagnostics.
  • Definition of global and regional regulatory strategies.
  • Support for drug development, with integration between clinical, regulatory and quality areas.
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The structure behind ELS Group's Research and Development Services.

ELS Group’s Research and Development services are structured to support companies that need to transform scientific knowledge into viable, safe, and regulatory-compliant products, from the initial stages to technical and strategic validation. More than executing isolated R&D steps, ELS Group acts as an integrated technical framework, connecting science, regulatory risk, and strategic decision-making throughout the entire development cycle.

This structure is supported by concrete pillars:

Integrated international operations with technical teams distributed across 11 countries.

Experts with hands-on experience in pharmaceutical development, medical devices, cosmetics, supplements, and medicinal cannabis.

Integration between Research & Development, Regulation, and Quality, avoiding rework and unfeasible technical decisions in the future.

Active participation of group experts in technical committees, scientific forums, and regulatory environments.

Proprietary methodologies for risk management, technical feasibility, and development strategy design.

Secure document and digital infrastructure with proprietary systems and advanced cybersecurity layers.

This approach allows ELS Group to act not only as a Research and Development service provider, but as a technical extension of the client, supporting critical decisions, reducing uncertainties and accelerating viable paths to market.

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 research and development services in the pharmaceutical industry.

Research and Development involves the creation, evaluation, and technical and scientific validation of products, including studies, formulation development, risk assessment, and preparation for regulatory and market requirements.

Research and Development should begin from the product conception stage, even before final decisions on formulation, studies, or industrial investments, ensuring regulatory and strategic alignment.

Yes. Considering regulation from the outset reduces rework, speeds up registrations, and avoids technical decisions that could prevent product approval in regulated markets.

No. We work in Research and Development for medicines, medical devices, cosmetics, supplements, food, medicinal cannabis, and other regulated products.

Yes. We support the planning, evaluation, and structuring of preclinical, clinical, and stability studies, always in line with applicable regulatory requirements.

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 with the main regulatory authorities in each region, allowing it to align global strategies with the specific regulatory requirements of each market.