Our Regulatory Affairs Services
- Local interaction with Competent Authorities
- Regional geographic roll-out in Africa and the MENA region (submission strategy, dossier preparation, submission and follow-up)
- MA lifecycle management (incl. administrative, safety and CMC variations, renewals…)
- Local regulatory intelligence and training
- E2E local outsourcing (incl. geographic roll-out and lifecycle management)
- Labelling and artwork management
- Regulatory information and document management (IDMP, publishing, data entry, submission management, translations…)
- Legal compliance
- Regulatory affairs services for Health products: Medical Devices, Food Supplements, Cosmetics, Reagents
Our Quality Assurance GMP Services
- Quality Management Systems (QMS) set-up, validation and management
- Quality risk management (QRM)
- Commissioning, Qualification and Validation (CQV)
- Commercialization readiness (incl. technological transfer, scale-up…)
- Audits and Inspections readiness (pre-and post-approval)
- Remediation services (CAPA plans, deviations, OOS…)
- Product Quality Review (PQR)
- Facilities engineering (design, implementation, qualification)
- Computer System Validation (CSV)
Our Training & Coaching Services
- Regulatory Affairs
- Pharmaceutical Production
- Quality and Quality Assurance
- Analytical Development and Quality Control
+30
African countries reached by HealthCare Solution
Contact Us
PLG Office
12 Boulmane Street, First Floor N°11
Bourgone – Casablanca – Morocco
By email: [email protected]