Our Services

General Management

General Management & Operations Improvement

Quality Systems & Auditing

QMS & Audits
& Training

Regulatory
Support

Pharmacovigilance & Cosmetovigilance

Pharmaceuticals

Qualification
& Validation

New Product
Development

GENERAL MANAGEMENT & OPERATIONS IMPROVEMENT

  • Interim Management
  • Technical evaluation for Merges & Acquisitions, Partnering
  • Portfolio Management
  • Industrial strategic plans (grow – divestment)
  • Cost center to Business center definition projects.
  • Project Management & Contract negotiation
  • Technical support to facilities upgrade or new facilities construction
  • Operations Improvement (Lean, 5S, DMAIC)
  • KPI’s definition, implementation and follow up
  • Implementation of on line manufacturing information gathering systems

QMS & Audits...

  • Design, implementation and improvement of QMS processes, audits to determine compliance for: 
    • Pharmaceuticals (GDP, GMP, GVP, GLP)
    • Medical Devices (ISO13485, MDR, IVDR)
    • Cosmetics (ISO22716) 
    • General QMS requirements (ISO9001, ISO14001)
  • Support to compliance with GDP (certified auditor of GDP CEIV IATA program).
  • Audits of Facilities, Subcontracted activities
  • Support to third part audits
  • Preparation/Review of technical documentation (SOPs, Quality Manual, PQR…).

Auditors IRCA, ASQ certified
Auditor of GDP CEIV IATA program

... & Training

  • Training services covering the main areas of pharmaceutical, medical devices, cosmetics and food additives. Courses tailored according to company needs.
  • QMS processes and their implementation (Quality events, change control, effective management review, KPI definition…)
  • Data integrity
  • Training for auditors
  • QMS according to ISO13485
  • Design Control (820.30 CFR)
  • GLP, GMP, GDP, GVP
  • PV training

Regulatory Support

Regulatory activities related to medical devices (transition to MDR and IVDR), pharmaceutical, cosmetic, biocidal products.

Support to Authorization submission for warehouses. Design of warehouse infrastructure and processes in compliance with GDP requirements. 

Pharmacovigilance & Cosmetovigilance

  • European Qualified Person Responsible for Pharmacovigilance (EU-QPPV)
  • Local pharmacovigilance representative (Spain: PV contact person)
  • Design and implementation of the PV system. PV SOPs
  • PSMF writing and update
  • Literature searches (international & local), MLM and PV obligations L2A management
  • PSURs, RMPs, “ad-hoc” safety reports, SDEA, writing
  • Management of EudraVigilance Registrations (MAH, EUQPPV, products, PSMF code). EVDAS listings (e-RMRline listings)
  • PV management & consultancy
  • Cosmetovigilance management

Qualification
& Validation

  • IT validation according to 21 CFR Part11 and GMP
  • Infrastructure and Equipment qualification
  • Cleaning validation 
  • Metrology

New Product
Development

  • New product development for Pharmaceuticals, Cosmetics and Food supplements
  • Galenical and Analytical Development
  • Support to Regulatory Documentation 

GENERAL MANAGEMENT
& OPERATIONS IMPROVEMENT

  • Interim Management
  • Technical evaluation for Merges & Acquisitions, Partnering
  • Portfolio Management
  • Industrial strategic plans (grow – divestment)
  • Cost center to Business center definition projects.
  • Project Management & Contract negotiation
  • Technical support to facilities upgrade or new facilities construction
  • Operations Improvement (Lean, 5S, DMAIC)
  • KPI’s definition, implementation and follow up
  • Implementation of on line manufacturing information gathering systems

QMS & Audits...

  • Design, implementation and improvement of QMS processes, audits to determine compliance for: 
    • Pharmaceuticals (GDP, GMP, GVP, GLP)
    • Medical Devices (ISO13485, MDR, IVDR)
    • Cosmetics (ISO22716) 
    • General QMS requirements (ISO9001, ISO14001)
  • Support to compliance with GDP (certified auditor of GDP CEIV IATA program).
  • Audits of Facilities, Subcontracted activities
  • Support to third part audits
  • Preparation/Review of technical documentation (SOPs, Quality Manual, PQR…).

Auditors IRCA, ASQ certified
Auditor of GDP CEIV IATA program

... & Training

  • Training services covering the main areas of pharmaceutical, medical devices, cosmetics and food additives. Courses tailored according to company needs.
  • QMS processes and their implementation (Quality events, change control, effective management review, KPI definition…)
  • Data integrity
  • Training for auditors
  • QMS according to ISO13485
  • Design Control (820.30 CFR)
  • GLP, GMP, GDP, GVP
  • PV training

Regulatory
Support

Regulatory activities related to medical devices (transition to MDR and IVDR), pharmaceutical, cosmetic, biocidal products.

Support to Authorization submission for warehouses. Design of warehouse infrastructure and processes in compliance with GDP requirements. 

Pharmacovigilance & Cosmetovigilance

  • European Qualified Person Responsible for Pharmacovigilance (EU-QPPV)
  • Local pharmacovigilance representative (Spain: PV contact person)
  • Design and implementation of the PV system. PV SOPs
  • PSMF writing and update
  • Literature searches (international & local), MLM and PV obligations L2A management
  • PSURs, RMPs, “ad-hoc” safety reports, SDEA, writing
  • Management of EudraVigilance Registrations (MAH, EUQPPV, products, PSMF code). EVDAS listings (e-RMRline listings)
  • PV management & consultancy
  • Cosmetovigilance management

Qualification
& Validation

  • IT validation according to 21 CFR Part11 and GMP
  • Infrastructure and Equipment qualification
  • Cleaning validation 
  • Metrology

New Product
Development

  • New product development for Pharmaceuticals, Cosmetics and Food supplements
  • Galenical and Analytical Development
  • Support to Regulatory Documentation 

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