Policies and Certifications
Policies and Certifications
Our Certifications
GMP Certificates and Regulatory Authorizations
- Manufacturing / Importation Authorization, for both IMP and HMP:
MIA Number aM-61/2024, dated 30Apr2024
EudraGMDP Document Reference Number 92491
- GMP Certificate for HMP (Human Medicinal Products):
Certificate Number IT/77/H/2024, dated 30Apr2024
EudraGMDP Document Reference Number 174926
- GMP Certificate for IMP (Human Investigational Medicinal Products):
Certificate Number IT/77/H/2024, dated 30Apr2024
EudraGMDP Document Reference Number 174927
- Authorization as manufacturer of API (Active Substances) for clinical use:
Certificate N. API – 219/2024, dated 15Jan2025 (AIFA authorization release dated 25Nov2024)
- GMP Certificates for API:
Certificate Number IT-API/198/H/2024, dated 15Jan2025 (AIFA authorization release dated 25Nov2024)
EudraGMDP Document Reference Number 175093
For more info check the European EudraGMDP database
Management System Certifications
Environmental, Health and Safety Policy
1. Introduction
This document refers to Advaxia Biologics S.r.l. – site of Via Pontina km. 30.600 – 00071 Pomezia.
It concerns to Organization to ensure respect for health, safety and the environment in carrying out its research and development activities, which aim to improve people’s living conditions through the discovery of new or improved pharmaceutical solutions.
The company will endeavor to implement the principles and strategies outlined below and thereby contribute to the preservation of the environment and protection of the health of its employees, contractors, and the communities in which the Organization operates.
2. Responsibilities
3. Objectives
Organization is committed to achieve the following objectives:
- Comply with all Italian legal requirements, Italian laws, and applicable regulations and standards for worker health and safety and the environment.
- Continually improve policy, programs, and behavior regarding the environment, prevention, and protection of health and safety, taking into account technical progress, scientific knowledge, employee needs, and community expectations.
- Evaluate the impact of its activities, products, and processes and adopt specific prevention and emergency procedures in environmental and safety areas.
- Promote energy-efficiency projects that help to reduce air pollution and protect biodiversity, along with activities to encourage the saving of water resources and, more generally, all natural resources.
- Monitor direct and indirect emissions to establish GHG emission reduction targets.
- Minimize the disposal of all waste products by reducing material consumption and maximizing internal reuse and recycling, and ensure that waste is managed and disposed of in accordance with applicable regulations, eco-friendly principles, and good business practices.
- Identify roles and responsibilities within the organization and assign necessary and appropriate resources to achieve HSE goals and make further improvements when necessary to protect the interests of the company and its employees, the community, and the environment.
- Ensure that contractors, subcontractors, suppliers, and customers are aware of our initiatives and encourage the adoption of this policy by all companies working at the site, considering the application of safety and environmental aspects as a criterion for evaluating suppliers.
- Provide appropriate training and information to all our employees to increase awareness and a sense of responsibility and engagement in the prevention and protection of the environment, health, and safety.
- Conduct regular audits to ensure that all HSE activities are carried out in accordance with this policy.
- Promote effective, streamlined, and transparent communication that ensures the dissemination and easy understanding of information useful for prevention purposes and the necessary cooperation at all levels of the company.
- Implement this policy, distribute it to internal and external personnel to make it available to the public and all interested parties, and review it periodically through a management system related to environment, occupational health, and safety, in compliance with the requirements of UNI EN ISO 14001:2015 and UNI EN ISO 45001:2023.
Date: 14 November 2023
Diversity and Inclusion Policy
Advaxia Biologics promotes a stimulating, creative and non-discriminatory workplace for all employees and collaborators.
We are committed to respecting and fostering human rights, in line with the Universal Declaration of Human Rights and the United Nations Guiding Principles on Business and Human Rights.
We promote diversity, we practice equity and fairness, and we express courtesy in our interactions with people every time that the Company interacts with workers, candidates, customers, and suppliers.
Our organization is committed to:
- Forbidding any conduct that may adversely affect a person’s dignity.
- Having zero tolerance for harassment and any form of discrimination related to:
– sex
– gender identity
– age
– origin
– religion
– sexual orientation
– physical appearance
– health
– disability
– political views
– nationality
– family situation - Creating equal opportunity for all employees or candidates in hiring processes, access to training, compensation, welfare, internal mobility, and professional development.
- Promoting diversity, as we believe that the diverse identities of our people are a strength and a key ingredient of our success.
The only factors we take into consideration are skills, experience, and personal aptitudes.
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Date: 9 September 2023
Gender equality policy
The IRBM Group adopts a Gender Equality policy that aims to recognize, protect, and give value to male-female differences and equal opportunities in the workplace: from recruitment and hiring practices to professional and career development, as well as the valorization of leadership styles.
We recognize the need to empower women to make professional choices without them becoming objects of discrimination.
The ultimate purpose of policies relating to Equal Opportunities is to establish a set of initiatives and norms aimed at overcoming unconscious bias and unfavorable conditions, and ultimately realizing gender equality in the workplace.
This document contains references to connected policies related to human resources management, careers, and internal and external communication.
The IRBM Group aims to pursue gender equality, to enhance diversity, and to support women’s economic empowerment through the following actions:
- Strengthening the concept of Equal Opportunities according to the European Employment Strategy: getting women into all professional roles by ensuring equal pay.
- Initiating new business development and leadership strategies oriented towards gender equality by improving the conditions of women within the economic framework.
- Promoting the concept of equality in the participation and representation of our organization in relations with stakeholders.
- Promoting equitable participation among speakers in panels, conferences, other scientific or non-scientific events, and in training and development opportunities.
- Contributing to the improvement of the balance between men and women within decision-making processes in an economic-social dimension and within work groups.
- Promoting equal social and civil rights for men and women.
- Contributing to increased knowledge of social rights legislation in the EU.
- Monitoring the presence of Equal Opportunities policies in community activities that have influence on everyday life.
- Countering gender-based violence.
- Promoting the elimination of stereotypes and unconscious bias by overthrowing gender bias within internal and external policies through effective communication and awareness raising process.
The identified KPIs in accordance with UNI PdR 125:2022 are an important part of the information needed to determine and explain how our organization progresses toward its goals.
This gender equality policy is:
- Defined by Top Management, in coordination with the Steering Committee.
- Communicated and disseminated within the IRBM Group and to its stakeholders.
- The subject of corporate management awareness and training to develop women’s career and leadership.
- Reviewed or periodically confirmed (at least once a year) based on events, changes, and the results of monitoring and audits.
Coordinated by the person in charge, designated by Management, and with organizational and gender expertise.
Top Management allocates resources (human, economic and infrastructural), responsibilities and authority, adequate for the pursuit, achievement and maintenance of the gender equality objectives established in the strategic plan.
This policy, which is available on the company website, is reconfirmed or updated after a periodic review as part of the verification and improvement of the management system.
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Pomezia, 15 September 2024
