ELS Solutions - Research and Development

Our process includes the following stages:

By creating and implementing optimized and innovative processes, ELS Solutions empowers the customer with earlier, more efficient and more profitable solutions, ensuring their sustained growth.

Medical Devices R&D/IP

Medical Product Testing Projects and Operations

Medical product testing projects and operations require careful planning and execution. ELS Solutions can support you with strong capabilities, including:

  • Strategy and Management of Pre and Post-Clinical Studies;
  • Medical Writing/Translation;
  • Clinical Evaluation Report (CER) Writing;
  • Pre-Clinical Animal Study and Design;
  • Clinical Trials;
  • Consultancy Services;
  • Design and Management of Real-World Evidence Studies.

Medical Device Vigilance

The range of services includes, but is not limited to:

  • Consultancy in medical devices and project management, in compliance with current guidelines;
  • Establishment of appropriate contractual agreements and oversight;
  • Management of Safety Data and Global Safety Database;
  • Adverse Device Effects and Medical Device Incident Assessment and Monitoring;
  • Preparation and submission of Device Surveillance Reports;
  • Medical assessment, including literature research and review;
  • Appointment of the Person Responsible for Regulatory Compliance (PRRC);
  • Periodic summary reports, including Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), Periodic Benefit-Risk Evaluation Reports (PBRERs), among others;
  • Pre-inspection audits and consultations.

Preclinical Advisory Services

Creating a detailed preclinical plan for subsequent stages of your asset’s development is crucial. Our nonclinical regulatory team specializes in developing plans that meet regulatory requirements to advance a product to the clinic and beyond. These services include:

  • Assessment of technical data, including chemistry/manufacturing, preclinical, and clinical data;
  • Determining the appropriate regulatory procedure and legal status for the products;
  • Proposing optimal filing and submission strategies;
  • Establishing regular communication with regulatory authorities to facilitate compliance;
  • Identification and management of external resources/experts.

Clinical Advisory Services

Our clinical development team specializes in designing and executing comprehensive product development programs. With a wide range of experts, including physicians, biostatisticians, and clinical scientists, our team can help design a development plan that reduces risk and maximizes clinical success.

Our clinical development services include:

  • Integrated development plans for multifunctional products;
  • Minimum target product profiles and associated clinical development plans;
  • Clinical trial design;
  • Biomarker and companion diagnostic strategies;
  • Global and regional regulatory strategies;
  • Pharmaceutical and medical device product development.

R&D/IP in Pharmaceuticals

Design & Development

  • Experience in a wide range of pharmaceutical dosage forms and routes of administration:
  1. Plant-derived substances and extracts;
  2. Chemical and semi-synthetic substances;
  3. Biological and biotechnological products.
  • Selection of key starting materials and GMP requirements according to applicable guidelines;
  • Definition of critical attributes of drug substances;
  • Definition of formulation development programs and manufacturing processes, including supervision and final review of results;
  • Quality design and space planning;
  • Analytical development programs and review of validation protocols and reports;
  • Production and analytical transfers, including on-site support;
  • Selection of packaging materials and medical devices for administration;
  • Process design and validation, including scale-up;
  • Planning and execution of stability programs for ICH and other regions, including supply chain requirements;
  • Requirements for the manufacturing, analysis, and distribution of Investigational Medicinal Products (IMPs).

Early-Stage and Late-Stage Services

The range of services includes, but is not limited to:

  • Consultancy in medical devices and project management, in compliance with current guidelines;
  • Establishment of appropriate contractual agreements and supervision;
  • Management of Safety Data and Global Safety Database;
  • Adverse Device Effects and Evaluation and Monitoring of Medical Device Incidents;
  • Preparation and submission of Device Surveillance Reports;
  • Medical assessment, including research and literature review;
  • Appointment of the Person Responsible for Regulatory Compliance (PRRC);
  • Periodic summary reports, including Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), among others;
  • Pre-inspection audits and consultations.

Preclinical Advisory Services

Creating a detailed preclinical plan for subsequent stages of your asset’s development is crucial. Our nonclinical regulatory team specializes in developing plans that meet regulatory requirements to advance a product to the clinic and beyond. These services include:

  • Assessment of technical data, including chemistry/manufacturing, preclinical, and clinical data;
  • Determining the appropriate regulatory procedure and legal status for the products;
  • Proposing optimal filing and submission strategies;
  • Establishing regular communication with regulatory authorities to facilitate compliance;
  • Identification and management of external resources/experts.

Clinical Advisory Services

Our clinical development team specializes in designing and executing comprehensive product development programs. With a wide range of experts, including physicians, biostatisticians, and clinical scientists, our team can help design a development plan that reduces risk and maximizes clinical success.

Our clinical development services include:

  • Integrated development plans for multifunctional products;
  • Minimum target product profiles and associated clinical development plans;
  • Clinical trial design;
  • Biomarker and companion diagnostic strategies;
  • Global and regional regulatory strategies;
  • Pharmaceutical and medical device product development.

Other services

Regulatory & Quality

ELS Solutions is a certified company in Europe and Latin America, with strong technical and strategic knowledge in Regulation and Quality Assurance.

Distribution Headhunting

ELS Solutions is a certified company in Europe and Latin America, with strong technical and strategic knowledge in Regulation and Quality Assurance.

Import

ELS Solutions provides a robust Import, Warehousing, Billing and Customer Service service, in the countries where it is represented, so that the customer controls their business, their margin and does not need to depend on the distributor, focusing on increasing of sales.

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