J2Fpharma team has a robust experience in full Development & Regulatory Project Management.
The team can coordinate your Projects on a daily basis and in a pragmastism way, making regular reporting as per your internal requirements.
After analysis of client objectives, J2Fpharma provides a full package including strategy/development scenarios, daily project coordination, associated budget and timelines, to ensure successful Product Development and registration in your targeted markets.
1
Day to day coordination of development and CMC projects to meet timelines and objectives.
2
Complete SWOT analysis upon request.
Proactive and pragmatic approaches.
3
Presentation, reporting tools, return on experience.
QC of all submitted reports and deliverables.
4
Proposal and evaluation of budget and timelines for specific activities.
Do not hesitate to contact us for any questions
or to get more information about our services.
Board member for formulation and PK evaluation
CTD dossier redaction for WHO submission
Scientific advice
Evaluation of Nitrosamines according to EMEA request
Analytical validation according to Brazilian guidelines
Statistical evaluation (formulation/process/analytics)
Trainings for US-FDA CMC requirements
Audits of data