We are always on the look-out of the perfect balance between client expectations and efficient solutions within regulatory compliance.
Audit and “Creating Compliant Solutions” for Quality & Regulatory compliance in Life Science Industry (20 year experience): “ To be more compliant but efficient”
Our motivation is to improve Health for patients. The main objective is to build bespoke solutions with our clients. We continuously update our knowledge in Current Regulations for creating Quality workflow process. We provide deliverables as solutions for innovating together.
Updating / Creating Quality System “To be more efficient but compliant” (Drugs: ICH Q6-8-9-10-11 & ISO 9000 – US FDA 21CFR part 210-211; MDD: ISO 13485 & MDD 93/42 EEC amended 2007/47 EC - US FDA 21 CFR part 820- part 11)
CAPA plans: Quality Audits (GMP & ISO 9001 - ISO 13485 & 21 CFR US FDA); Assessment for USA (21 CFR US FDA), CANADA, Taiwan (ROC) & Japan and Brazil (ANVISA) – Emerging Markets
Quality Plans: CAPA Assessment – Inspections and Audits preparation (SME concept)
Regulatory and Quality strategy for registration (MAA) and Reimbursement
Manufacturing (aseptic and sterile) facilities qualification
Our experience during 20 years in both small and majors organisations in the Medical and Pharmaceutical Industry gain us strong expertise and knowledge with wise maturity, expectations understanding, clients needs and good balance between know-how and bespoke deliverables.
We claim to be Client Specific and professional “Creating Compliant Solutions”
Simply reactive but more proactive
We focus on great attention to details with strong interpersonal and communication skills
We continuously improve our analytical and problem solving skills. We enhance our ability to adapt to new and multicultural environment and to apply acquired knowledge and skills sets to new situations.
Continuously efforts are made to training and performing audit for continuous improvement
We believe in strong cross functional skills to work with and support R&D and Marketing activities
Technical assets are important in our field so we are constantly updating our knowledge in Scientific, Medical, Technical, Regulatory and Quality matters.
We want that your needs become our concerns.