HALTYS is a Global Consultancy specializing in Quality, Audit, and Compliance within the Life Sciences sector.
Our consultants leverage extensive experience, delivering robust technical expertise complemented by a tailored facilitation approach to meet the specific objectives of our partners.
Standards and regulations: EU Vol. 4, EU GMP/GDP, 21 CFR part 210/211/820, ICH Q7/Q9, IPEC Excipient GMPs/GDP, ISO13485, ISO 22716, ISO 17025, ISO 22000, HACCP, ISO 9001, Drug Nitrosamines risk analyzes etc.
References: Lonza Cell & Gene Therapy Netherlands for Kite Pharma - Merial France - Sanofi Pasteur France - Octapharma France - Assistance Publique Hôpitaux de Paris France - SQA Services US (Pfizer - Merck - Baxter) - SpineSave AG Switzerland - Blanco Medical Germany - Swiss Medtech Switzerland - Laboratoires Sicobel France - Martin Dow Pharmaceuticals France - Innothera France - VEEVA Systems Vault - IPSEN BIOPHARMA Speciality Care - BLUEPRINT MEDICINES US - FDA QRC US.
Sectors References: Cell and Gene Therapy CAR-T Cells - Human and Veterinary Vaccines - Human Blood Enzymes - Rares Diseases - Speciality Drug - Generic Drug - Spine Implant - Medical Furniture - Dermocosmetics - CSV Computer System Validation.
What are the core intervention topics we specialize in?
- Quality Assurance Systems, Operations, and Regulatory Compliance
- Internal and External Audits, EU and FDA Inspections Readiness
- Comprehensive Risk Assessment Across All Levels
- Project Management and Facilitation: Orchestrating Success
- Qualification and Management of Raw Materials, Suppliers, and CDMOs (Contract Development and Manufacturing Organizations)
- Deviation, Change Control, Complaint, Corrective and Preventive Actions (CAPA), and Key Performance Indicators (KPIs)
- Pharmaceutical Technology Transfer
- Computer System Validation (CSV)
- Medical Device ISO 13485
- Global Quality Commercial Operations : Creation, Support, Supervision and Management of Affiliates at Global Headquarter.
Company Details
- Employees
- 2
- Address
- 10 Rue Penthivere, Paris,ile De France 75008,france
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- haltys-pm.com
- Keywords
- FDA 21 CFR 210/211, FDA 21 CFR 820, EU GMP & EU Vol. 4, ICH Q7/Q9, ISO 13485, ISO 9001, ISO 22716, ISO 22000, GOOD MANUFACTURING PRACTICES, LIFE SCIENCES OPERATIONS, RISK ANALYSIS, INTERNATIONAL AUDITS, LIFE SCIENCES COMPLIANCE, LIFE SCIENCES STRATEGY, LIFE SCIENCES BUSINESS DEVELOPMENT, LIFE SCIENCES RISK MANAGEMENT, LIFE SCIENCES MARKET RESEARCH, MEDICAL DEVICE MARKET ACCESS, MEDICAL DEVICE REIMBURSEMENT, MEDICAL DEVICE DISTRIBUTION, QUALITY ASSURANCE, CERTIFICATION, GMP, CGMP, LIFE SCIENCES SUPPLIERS MANAGEMENT, Computer Systems Validation (CSV).
- HQ
- PARIS, ILE DE FRANCE
- Competitors
- Cinta Medtech, AM PM Pharmacy Malaysia, Pharma and MedTech Information (PhMTI), Laboratoire SYLAMED, MedTech Key, ExplorTech - Medtech Consulting, Medtech Investors Database, GM Pharmaceuticals, SynapCon - Faster Clinical Trials (SaaS) AI & ML-based platform for Medtech, Biotech and Pharma, Medtech Uganda & Uganda Pharma Expo.
Haltys Pm 'pharma & Medtech' Questions
Haltys Pm 'Pharma & Medtech''s website is haltys-pm.com
Haltys Pm 'Pharma & Medtech''s LinkedIn profile is https://fr.linkedin.com/company/haltys-pm
Haltys Pm 'Pharma & Medtech' has
2 employees.
View email and phone details for 2
employees at Haltys Pm 'Pharma & Medtech'.
Haltys Pm 'Pharma & Medtech''s industry is
Pharmaceutical Manufacturing
Haltys Pm 'Pharma & Medtech''s top competitors are
Cinta Medtech,
Am Pm Pharmacy Malaysia,
Pharma And Medtech Information (Phmti),
Laboratoire Sylamed,
Medtech Key,
Explortech - Medtech Consulting,
Medtech Investors Database,
Gm Pharmaceuticals,
Synapcon - Faster Clinical Trials (Saas) Ai & Ml-Based Platform For Medtech, Biotech And Pharma,
Medtech Uganda & Uganda Pharma Expo.
Haltys Pm 'Pharma & Medtech''s categories are Pharmaceutical Manufacturing
