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