• GxP Audits:
  • Pharmacovigilance,
  • CROs,
  • Warehouse/Distribution/Logistics,
  • MAH activities,
  • Quality Management System
• Performance audits:
  • regular audits,
  • pre-inspection audits,
  • Inspection Results Mitigation audits
  • Preparatory audits for ISO 9001 certification
• Qualification and Periodical evaluation Audits
  • Service providers

Drug safety – Pharmacovigilance

1. Availability to act 24/7 as local PV contact person and deputy
2. Development and maintenance of PV System, Pharmacovigilance System Master File (PSMF)
3. Expertise in: a. Management of: …ICSR, …DHCP, …RMM b. PV Service providers qualification &periodical evaluation c. Preparation of PV Agreements d. Pharmacovigilance training of PV and non-PV personnel e. Regulatory intelligence monitoring f. PV audit/inspection readiness
4. Management of: – Individual Case Safety Reports (ICSR), – Direct Healthcare Professional Communication (DHPC), – Risk Minimization Measures (RMM), – PV Service providers qualification & evaluation, – Pharmacovigilance agreements
5. Pharmacovigilance training of PV and non-PV personnel
6. Regulatory Intelligence monitoring
7. Audit/Inspection Readiness

Materiovigilence

1. Expertise in: – Adverse Events Incidents, – Field safety notification (FSN), – Field safety corrective actions (FSCA)
2. Materiovigilance trainings

1. Registration and maintenance of medicinal products, medical devices and non pharma products (food supplements, cosmetics, biocides)
2. Registration process (new submissions) and Post marketing regulatory maintenance of Medicinal products (renewals, variations, PSUR, labelling Artwork updates),
3. Registration/notification process for food supplements, biocides, cosmetics
4. Management of educational materials for Medicinal products and medical devices
5. Samples management (approvals, tracking, internal procedures, compliance and reconciliation – internal, with service providers)
6. Preparation and Implementation of client customised procedures describing cross-functional processes (local, with global functions, with service providers)
7. Temporary/Long-term Regulatory Affairs staff outsourcing 

1. Consultancy/project management for set-up/upgrading your company Quality Management System
2. Company customised QMS with effective process and communication flows (applied for company activities and processes, correlated with organisational structure)
3. Customised local QMS, aligned with global/regional one (e.g: Local representative offices of global companies)
4. Integrated Cross—functional QMS (integrated process flows, e.g: Regulatory Affairs, Pharmacovigilance, Supply chain, Marketing, Sales force)
5. Integrated compliant QMS (various regulatory and legislative requirements: e.g, ISO, GxP, MDR, HACCP, GAMP, etc)
6. QMS documentation Establishment and maintenance: Quality Manual, Standard operating procedures, Working instructions, Trainings of personnel, Templates/ Forms documented evidence
7. Offering technical assistance for customized Quality Compliance ready-to-use documents
8. Temporary/Long-term Quality Assurance outsourcing
9. Customized trainings for your organization (QMS, QA)

1. SHORT/LONG TERM TEMPORARY REPLACEMENT: Pharmacovigilance, Regulatory Affairs, Quality Assurance, Clinical Trials
2. GxP Computer System Validation,
3. Medical translations,
4. Risk management,
5. Professional advice and assistance in applying GxP and other regulatory requirements for strategic and compliance decissions, assistance in preparation of Quality/Distribution/Pharmacovigilance Agreements