Our assets
- Regulatory Excellence
- Sustainability
- Innovation and Efficiency
- Client-Centered Solutions
- Data Protection and Privacy
- Ethical Integrity
We ensure all operations adhere to the highest standards of regulatory compliance. Our processes are meticulously aligned with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP). Our authorizations, by the French Health Authority (ANSM), reflect our unwavering commitment to quality and compliance.
We prioritize sustainable practices to minimize our environmental footprint. Our initiatives include green logistics, waste reduction, and sustainable sourcing. We are committed to fostering a healthier planet and ensuring a sustainable future for generations to come.
We are dedicated to continually improving our processes and services through innovation. By integrating cutting-edge technologies and methodologies, we enhance efficiency and ensure our partners benefit from the most advanced solutions in the pharmaceutical industry.
We strive to deliver tailored solutions that meet the specific needs of our clients. Our commitment to providing reliable, high-quality services ensures that our partners receive the support they need to successfully navigate the French pharmaceutical market.
We are committed to safeguarding personal data in compliance with the General Data Protection Regulation (GDPR). Our Data Protection Officer (DPO) ensures rigorous data privacy practices, handling personal data with the highest level of security. For any inquiries about your personal data, please contact us at: hello@atessia.fr
We operate with the highest level of integrity in all our activities. This commitment ensures transparency, honesty, and ethical practices in every aspect of our business, building trust and long-term relationships with our partners.
- Wholesaling
- Batch follow up,
batch recall - Medical Information
- Promotional activities
- Pharmacovigilance
- Storage
Wholesale involves several stages (ordering, distribution, transport).
Each stage is carried out either directly by us, or by selected and duly qualified subcontractors.
As an exploitant, we ensure an appropriate and continuous supply to the national market at all times, so as to cover the patient needs in France.
Monitoring and maintenance of product conformity on the market.
Following the appearance of an adverse effect or the detection of a non-conformity, we perform an analysis of the situation, set up remediation if possible, and may have to recall one or more batches of medicines.
At Aphilæ Pharma, all product quality complaints are assessed and investigated appropriately:
- Identify the causes, assess the recurrence of the defect, its potential impact on other batches/products, associated risks, etc.
- Implement appropriate corrective and preventive actions (CAPA).
- Pharmaceutical request: concerns the drug itself, its galenic form or shelf life, for example.
- Medical request: concerns the patient’s pathology, or the combination of the drug with other treatments, for example.
Advertising refers to any form of information aimed at promoting the prescription, dispensing, sale or consumption of medicines.
Drug advertising is subject to very strict regulations. Pharmaceutical laboratories must obtain a visa from the ANSM authorizing the distribution of drug advertising.
The purpose of pharmacovigilance is to monitor, assess, prevent and manage the risk of adverse effects resulting from the use of medicines:
- to prevent the risk of adverse effects resulting from their use within or outside the scope of their authorization/registration, or from occupational exposure;
- to promote the safe and effective use of these products, notably by regularly informing patients, healthcare professionals and the public of safety data.
We take care of the stocks of your product, our warehouse facilities are well established subcontractors, selected and qualified by us on stringent standards
- Role and Responsibilities
- Skills and Experience
- Types of Responsibilities
- Freedom of Judgment and
Pharmaceutical Authority - Delegation and
Replacement
The Responsible Pharmacist (RP) is a pivotal role essential to the organization of any pharmaceutical laboratory « exploitant » involved in the manufacture, exploitation, and distribution of medicinal products for human use in France. The RP ensures the quality of the medicine and the safety of the patients. Their responsibilities, defined by the regulations in articles R.5124-16 to R.5124-41 of the Public Health Code, include organizing and supervising all pharmaceutical activities: manufacturing and batch release, advertising, information, pharmacovigilance, follow-up and withdrawal of batches, distribution, import and export, storage, and transport. Unlike the qualified person within the European Union (directive 2001/83/EC, article 48), the RP has personal responsibility for all pharmaceutical activities.
The skills and practical experience of the RP are validated by the National Council of the Order of Pharmacists. Recent modifications to the practical experience requirements were made by Decree No. 2022-324 of March 4, 2022 (CSP Articles R.5124-16 to R.5124-18). The RP is appointed by the competent corporate body of the company and then declares themselves to the national competent authority: the ANSM.
Legal and Criminal Liability
The RP is a member of the company’s management and the main contact with the Health Authorities, holding personal responsibility for the compliance of the pharmaceutical establishment with the Public Health Code.
Disciplinary Responsibility
The RP must respect professional ethics and comply with deontological obligations.
Civil Liability
The RP shares civil and criminal liability with the manager(s) of the company.
The RP preserves their freedom of professional judgment in the exercise of their functions (CSP Article R.4235-3). They have authority over all pharmaceutical staff (CSP Article R.5124-36) and appoint delegate pharmacists.
The RP can delegate some pharmaceutical activities. The delegate pharmacist, within the limits of their delegation, is bound to the same obligations as the RP (CSP Article R.4235-68). In the event of absence, the RP is replaced by an interim responsible pharmacist (CSP Article R.4235-70), who assumes the same functions, assignments, and responsibilities during the replacement period.