Formulation Development
Quality is central to every project at FTF Pharma. Our development work is designed to meet the expectations of regulators in the US, Europe and other global markets - with sound documentation, data integrity and audit readiness.
Quality policy & quality system
Our dedicated QA-IPR group oversees quality across formulation and analytical development, documentation and data.
Content to be provided by FTF Pharma: the approved quality policy statement and a summary of the quality management system (SOPs, training, data integrity, change control, etc.).
Certifications
Certificate name
Issuing body & year
Certificate name
Issuing body & year
Certificate name
Issuing body & year
Content to be provided by FTF Pharma: list of certifications and accreditations (with certificate images) and regulatory approvals.
Compliance
cGMP manufacturing services for oral solids for scale-up and pilot BE batches
Mock-up audits of partner API / FP and BE / CT sites
Development documentation prepared for US, EU and other global regulatory submissions
Compliance with the Rights of Persons with Disabilities Act, 2016 and Rules, 2017
Content to be provided by FTF Pharma: regulatory inspections, audit history and compliance statements to be published.
Facility
Formulation development, analytical and stability facilities at our R&D centre in Sanand, Ahmedabad.
View Infrastructure & Equipment