TURN COMPLEX
INTO EASY

EMPOWERING QUALITY
THROUGH PEOPLE AND
TECHNICAL EXPERTISE


VOCATION TOWARDS RESULTS
AND HUMAN RELATIONSHIPS


about us

Qualideas is the result of our know how and sense of resposibility. Estabilished in 2010, our goal is to provide you with achivable and complying solutions which make you feel proud of your team, products and capabilities.

TURN COMPLEX INTO EASY

We embrace complex Quality and Regulatory Regulations and crumble it to what they mean in their simplest from for each particular scenario. This saves your time and brainpower to focus on your main activity.


OUR CLIENTS

Qualideas delivers solutions from Argentina to LATAM for:


Pharmaceutical

Food & Dietary Supplements

Veterinary

Cosmetics,
Health Care


Medical devices

Home cleaning supplies

Wharehouses & Distribution

ISO standard companies


Solutions

QUALITY

Professional Advise & Project Management
Qualified professionals designing ideas and leading your strategic processes
Suppliers Development & Qualification
Strategic plan design - documents compilation - audits - action plan tracking
Qualification & Validation
Services - equipments - areas - analytical methods - cleaning - processes
Annual Product Review
Strategy design - data processing - report issue
Risk Assessments
Customized analysis - strategy & document design
Self Inspection
Execution - recommendations - action plan tracking
Training
Real training experience on the work flow - personal development

Documentation

Strong, auditable operational documentation

REGULATORY

      Professional Advise & Project Management
      Best current regulatory practices at the reach of your hand.
      Market Access

      MAH, representative & distributor searching - company regitration - start up

      RRAA ASSISTANCE / OUTSOURCING
      Application form fillment - submission tracking up to approval - product life cycle maintenance - variations - BOH interaction on client's behalf - dossier due dilligence & GAP analysis - marketing authorization transfers

      TRANSLATIONS

      English - Portuguese - Spanish

      Specialists in technical and scientific medical vocabulary

      PHARMACOVIGILANCE

      Risk Management Plans

      Periodic Reports
      Local Submissions

      STRATEGIC SUPPLY

      Suppliers Searching - Portfolio Analysis and Development

      SALES & MARKETING

      Product Pipeline Assesment

      New Product Feasibility

      Leaflet & Artwork Development

      Sales Force Training

      PROCESS OPTIMIZATION

      Operative Improvement to Reduce Cycle Time and Cost

      Great People

      High Values

      Fantastic Results