Engineering and R&D Health Economics, Outcomes Research (HEOR) and Market Access Manufacturing Excellence (support function) Quality & Regulatory

Life Sciences

We offer a wide spectrum of services to Pharmaceutical, Medical Device, and Biotechnology companies. Our understanding of market dynamics, customer demands, and regulations means that we can assist you at every stage of the product lifecycle and help develop and embrace innovative processes and technologies.

...

Engineering and R&D

In order to innovate, organizations now need to discover, evolve, and accelerate all the time. At Amaris, with our engineering and R&D services, we help change concepts into reality and guide organizations towards innovation-led growth. Our dedicated approach on data integrity and data management help our customers to value and foster their digital assets in the competitive race for new drugs for patients.

Qualification & Validation of processes, equipments and computer systems (CSV)

Good Manufacturing Practice (GMP) validation activities requirements are essential for healthcare manufacturers. Healthcare products are validated through systems and processes carefully designed and implemented by our team of specialist consultants in order to ensure batch specifications and quality. Process, analytical methods, equipment, computer system and software, and cleaning methods validation are all offered by Amaris.

HVAC, Piping and Automation

Pharmaceutical production and quality relies on HVAC. While maintaining awareness of operating and EHS characteristics at each design step, we can complete process studies, P&IDs, and process layouts. Ensuring preparation and updating of project qualifications, as well as coordinating qualification activities of installations and ensuring quality standards in work inspections are all areas of expertise for Amaris specialist consultants. We also offer services in securing contracts and connection of services (chemicals, water, gases) and electricity.

Maintenance & EHS

Operational and predictive maintenance involves protecting the safety of all team members, contractors, and defining the EHS strategy for production sites. Amaris’ maintenance and EHS specialists use a global approach to propose strategies for long term, sustainable, and eco-friendly organization and production set up.

Medical Affairs & Pharmacovigilance

Precision and information gathering are crucial in today’s pharmaceutical, biopharmaceutical, and medical device landscape. From proof-of-concept to end-to-end services, our expert teams ensure product safety and confidence through consulting services in operations and technology across the whole pharmacovigilance journey.

Research & Development

Shifts in the market, regulatory, and reimbursement environment have put organizations providing healthcare R&D under increasing pressure to produce sustainable returns. Scaling the impact of new innovations therefore requires rethinking and transformation to maximize their value. At Amaris, we use advanced technology, real-world evidence, robotics, and AI to help our clients achieve sustainable life sciences R&D operations.

Commissioning & Decommissioning

Adhering to and anticipating updates to the 21 CFR outlined in GMP is how Amaris healthcare experts maintain safe, effective, and reliable equipment, processes, and system operations. We prioritize the IQOQ processes in our facilities design to ensure that they can accommodate proper cleaning and maintenance, as well as provide the maximum benefit to operations. From accurate facility and equipment sizing and designing the storage and flow of materials, to delivering operational support such as utilities, packaging, and labeling, Amaris’ experts commissioning and decommissioning services ensure a smooth and reliable transition.

Health Economics, Outcomes Research (HEOR) and Market Access

We leverage global expertise in economic modelling, real-world evidence, statistics and market access to design and deliver your product strategy. We combine our core market knowledge and robust analytical capabilities to help you understand the value of your product, improve positioning, and achieve competitive access.

Statistics

Getting key insights from clinical studies is critical to your product commercial strategy and reimbursement success. Individual patient data (IPD) analyses often hold the key to robust and differentiating economic evaluations and comparative effectiveness studies. Such research can provide necessary competitive advantage and support product positioning (...)

View offer details

Evidence review & value communication

Literature reviews are used to address research questions around such issues as the burden of diseases, unmet medical needs, efficacy, and safety of treatments. They are also considered core to the evidence base required by many reimbursement authorities worldwide. When executed well, reviews can be a powerful support to value strategy and can inform clinical (...)

View offer details

Real world evidence studies

The importance of real-world evidence (RWE) to commercial and regulatory outcomes as well as long-term product life-cycle management is well recognised. Amaris has significant experience in designing and implementing retrospective and prospective RWE studies to evaluate clinical, economic, epidemiologic, and patient outcomes. We understand the strengths (...)

View offer details

Evidence Synthesis

Conducting evidence reviews using systematic or targeted approaches is one of the core competences of our Evidence Synthesis team. We use state-of-the art methodology in line with the most rigorous evidence requirements. The research conducted within our organisation is published in peer-reviewed journals and conferences, and used to support reimbursement (...)

View offer details

Health Technology Assessment

Launch excellence and thorough planning is critical to success in access. As part of that, HTA submissions are an integral part of many reimbursement procedures across many key healthcare markets. Good execution requires excellent organization, strategic insight, good analytic capabilities, and attention to detail, as well as advanced clinical communication skills (...)

View offer details

Market Access, Pricing and Reimbursement

Market access challenges continue to grow, with payers looking for value for money, especially in uncertain times with increasing economic pressures. The Amaris team are skilled at unpicking the payer challenges and advising on the best approach to achieve the optimal price and maximum access for new products. We have a track record of supporting companies (...)

View offer details

Health economics modelling

Amaris is a trusted partner with a stellar reputation for conducting economic evaluations. Our team of health economists has an in-depth knowledge of research methods, combined with extensive consulting experience. We provide reliable and highly credible results to our clients. Our models are user-friendly, transparent, quality-checked, and based on (...)

View offer details

Manufacturing Excellence (support function)

Our holistic manufacturing support services help organizations remain competitive by optimizing operations with new technology and maintaining product integrity while ensuring quality standards and regulatory compliance. We have developed specific solutions on improving production lines through a dedicated lean approach as well as implementing GDP practices.

Project Management & Coordination

The healthcare industry is continually evolving, and with this comes pressure to creating efficiencies while improving patient outcomes. Amaris’ project management experts help organizations to accomplish their goals and objectives by focusing on specific end points and coordinating team efforts to achieve them.

Technology transfers

Effectively transferring products or processes from one site to another requires a comprehensive plan, standard operating procedures (SOP), and robust guidelines in place. Limitations on time and resources as well as regulatory requirements must be adhered to if a successful execution is to be completed. Managing product and process transfers are Amaris’ team of multifunctional life science consultants, which has demonstrable success in conducting transfers with efficiency while ensuring compliance throughout.

Procurement Methods

As experts in procurement fields, our specialists support organizations across projects such as CMO procurement and raw materials acquisition strategies. Amaris manages sourcing projects from start to finish, including RFI launching and supplier selection.

Logistics & Supply Chain Management (GDP, Cold Chain)

Enhanced infrastructure, complex data management, and effective collaboration are all becoming increasingly important as the awareness and availability of supply chain information advances. Amaris’ healthcare supply chain solutions support organizations in finding cost savings, optimizing operations, and pursing smart growth strategies.

Quality & Regulatory

Our driver is to help our clients achieve the highest level of quality. Our experts conduct GMP pre-audits all around the globe, and we provide daily support in quality assurance and quality control. We established this offer to go through FDA inspection with a gap analysis, recommendations, and implementation. We establish regulatory and compliance targets, and we drive projects in quality improvement and excellence.

Good Manufacturing Practice (GMP) Auditing

GMP audits confirm that an organization’s policies and procedures are in line with good manufacturing practices. At Amaris, we support our clients in implementing and maintaining GMP compliant processes, as well as helping ensure that production and quality standards are adhered to with GMP-compliant documents and consistent practices.

Quality Assurance & Quality Control

Ensuring that products meet the correct standards and are compliant with relevant regulations is the focus of our quality assurance and quality control experts. We offer quality improvements and gap assessments, CAPA/deviation management and improvement, and quality audit preparation, as well as the complete set up of labs and inspection preparation.

View offer details

Quality Improvement & Excellence

Continuous improvement is how we at Amaris help our clients to achieve the highest quality results in operational efficiency. Challenges such as mounting competition on a global scale, growing customer expectations, and a push for flexibility in operations to foster growth and expansion are all met by Amaris’ services. Our Lean Six Sigma offers also help to improve production efficiency.

Regulatory & Compliance

Our focus on quality ensures that our highly specialist healthcare consultants successfully work with organizations to support in developing and implementing integrated compliance programs. Audits, investigations, risk and gap assessments, regional compliance writing, and testing are all offered as part of our holistic regulatory and compliance services.

©2024 Amaris Consulting

Privacy Policy Terms and Conditions