Services

Market Research

  • Industry trends and forecast market growth to help on business decision process.

R&D

  • Development of solid, liquid and semi-solid formulations (galenic development).
  • Controlled release specialists.
  • Analytical Development and Validations.
  • Scaling Up and Technology Transfers. First Batch and Pilot Support.
  • Microbiological validations. Stabilities.
  • In vitro equivalences and Bioexemptions.

RRAA

  • Regulatory Strategy for Enabling and Registrations of Medicines, Food, Cosmetics and Medical Products.
  • Drafting of Dossiers Regulatory Strategy for Registrations and Enabling.
  • Drafting of CTD’s for export to LATAM, Eastern Europe, the Middle East and Africa.
  • Official Scientific Translations.
  • Dossier management service

CLINICAL AFFAIRS

    • Pharmacovigilance:
      • Notification of Adverse Effects.
      • Making Reports for Health Authorities
      • Mobile app on mobile phones for notifications.
    • Effectiveness and Security Monitoring (PMEEs) and Post-Approval Security Studies (PAAs) plans.
    • Preparation of IPAS and PGR’s (Risk Management Plans).
    • Medical Writings-Scientific Literatures:
      • Support for Claims advertising
      • Design of Clinical Protocols
      • Medical rational.

Quality

  • Local and Global GMP Compliance Audits (FDA, EMA, ANMAT, COFEPRIS, ANVISA, INVIMA). Writing Quality Manuals.
  • IQ OQ PQ Qualification Protocols.
  • PMVs and Process Validation.
  • Computer Validations.
  • Establishment and management of quality indicators. In vitro equivalences and Bioexemptions.

Training

  • We offer our colleagues all the training alternatives, using Gamification and modern didactics:  In Company, Courses and Workshops in person and online, Post-Graduate Courses.
  • We have our own classroom with Online Streaming and capacity for 25/30 participants, with live synchronous platform technology.