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:
- Plant-derived substances and extracts;
- Chemical and semi-synthetic substances;
- 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.