Our services
Why choose Aphilæ Pharma?
Choosing Aphilæ Pharma means partnering with a company dedicated to excellence, innovation, and integrity. We are not just a service provider; we are your gateway to the French market, committed to ensuring that your products reach the patients who need them most.
Services Offered
Our services are tailored to meet the specific needs of each client, with a personalized approach and an unwavering commitment to quality and compliance.
Quality
- We handle every complaint and ensure that all batch recalls are managed efficiently to minimize risks.
- We keep the marketing authorization (MA) dossiers up to date, ensuring compliance with the latest regulatory requirements.
- We conduct annual product quality reviews to maintain the highest quality standards for your medicinal products.
- We manage artwork and ensure storage of your medicinal products.
- We regularly audit and qualify your subcontractors to ensure compliance throughout the production chain.
Distribution
We Manage distribution on the French market in collaboration with MAH and the manufacturer.
Medical Information
- Our team is available around the clock to answer questions from healthcare professionals and patients.
- We answer questions from healthcare professionals and patients about marketed products.
Compliance
- At Aphilæ Pharma, compliance is at the heart of our operations.
- As a licensed Exploitant supervised by the French Health Authority (ANSM), we ensure full adherence to the French Public Health Code, GDP, GMP, and GVP standards.
- We uphold strict regulatory, ethical, and transparency principles through:
- Regulatory excellence: alignment with ANSM and EU directives.
- Ethical promotion: ANSM-approved materials and certified sales teams.
- Transparency: compliance with Loi Sapin II and anti-gift regulations.
- Data protection: GDPR-compliant processes under our DPO.
- Quality assurance: robust QMS, audits, and CAPA management.
- Partner oversight: qualification and monitoring of all subcontractors.
- Integrity, safety, and transparency guide every step of our work – ensuring that all products managed by Aphilæ Pharma meet the highest standards of quality and trust.e à compléter
Pharmacovigilance
- We guarantee a robust and compliant pharmacovigilance system that includes:
- Collection and management of adverse event reports from healthcare professionals, patients, and partners.
- Evaluation and submission of individual case safety reports (ICSRs) to the French Health Authority (ANSM) within legal timelines.
- Signal detection and risk assessment, performed in coordination with the EU Qualified Person for Pharmacovigilance (QPPV).
- Implementation of corrective and preventive actions (CAPA) following any identified risk or safety issue.
- Preparation of periodic safety reports (PSUR/PBRER) and contribution to Risk Management Plans (RMP).
- 24/7 local pharmacovigilance contact point, ensuring permanent availability for ANSM and healthcare professionals.
- Training and awareness programs for all teams and subcontractors involved in product safety.
- Close collaboration with ATESSIA VIGILANCES for medical evaluation, regulatory reporting, and safety signal management.
Promotional Activities
- We ensure that your promotional materials meet all regulatory standards.
- We certify your sales teams to ensure they comply with French regulations.
- We Support product launches and maintain communication elements with a valid visa.
Early Access Program
- We help define and implement early access programs, including submission strategies and follow-up.
- We guide you through each step to maximize the benefits of early access programs
Relations with Authorities
We facilitate interactions with regulatory authorities to ensure continuous compliance.
With Aphilæ Pharma, you have a reliable and dedicated partner to ensure your products meet all regulatory requirements and reach the market safely.
We are here to simplify your journey, allowing you to focus on your core mission: innovating and caring for patients.