Purpose
To provide comprehensive solutions to the needs of the pharmaceutical, cosmetics, veterinary and nutraceutical industries — serving Quality Assurance, Technical, Regulatory Affairs and Engineering departments and partnering in our clients' business development.
Quality
Quality is the cornerstone of our working philosophy and is defined by our own quality policy. We study every need and propose realistic, high-quality solutions adapted to each client and each moment, with the closeness of a trusted partner.
Experience
Our advisors bring years of experience from industry and from public agencies (AEMPS and EMA), endorsed by roles such as Qualified Person / Pharmaceutical Technical Director and Quality Assurance Director.
The people behind Afiplus
Complementary profiles covering the full life cycle of a medicine: from the laboratory to the marketing authorisation.
José Luis Herreros
Pharmacist, Specialist in Analysis and Control of Medicines and Drugs, with over 25 years in the public and private pharmaceutical sector.
- 12 years at the AEMPS and over 10 years in the private sector as Pharmaceutical Technical Director and Quality Assurance Director.
- Manufacture, control and regulation of medicines (injectable, oral and nasal forms), biologicals and vaccines.
- R&D&I, quality systems, auditing and GMP analytical control of cosmetics, food supplements and foodstuffs.
- UNE-EN ISO/IEC 17025 technical auditor.
- UNE-EN ISO/IEC 22000 lead auditor.
- Judicial expert witness.
Silvia Calatrava
Pharmacist, Specialist in Industrial Pharmacy and Galenics, with over 20 years in the pharmaceutical, biotech and nutraceutical industries.
- Quality Assurance specialist, expert in sterile-medicine processes and quality-culture improvement.
- Quality indicators: PQR preparation and risk analysis in accordance with ICH Q9 and GMP.
- International auditor of suppliers (APIs, contract manufacturing, packaging materials) and services (sterilisation, GDP transport and logistics, third-party analysis).
- Pre-assessment for certification of compliance with European GMP, GDP, FDA and ISO requirements before national and international authorities.
Our goal: real solutions for your needs
Quality systems adapted to each company, and a team that speaks your technical language.
Work with us