Services
Twelve pharmaceutical quality & regulatory services: GMP audit, gap analysis, QMS design, remediation, supplier qualification, inspection readiness, and training for USFDA, WHO, MHRA & Schedule M compliance.
Training
Comprehensive training programs tailored to your organization to build capability and ensure regulatory compliance.
Supplier Development & Qualification
Comprehensive qualification, auditing, and development of your supply chain partners.
QMS Health Check & Due Diligence
Robust Quality Management Systems review and structured action plans to ensure compliance.
Investigation Report Review
Detailed review of investigation reports to ensure root cause analysis and CAPA effectiveness.
Standard Operating Procedures
Development, review, and optimization of standard operating procedures for clarity and compliance.
Batch Production Records
Review and optimization of batch records to ensure right-first-time execution and data integrity.
Self-Inspection & Internal Audit
Enhancing internal audit programs and self-inspections to proactively identify and mitigate risks.
Study Protocol & Report Preparation
Expert preparation and review of technical study protocols and comprehensive summary reports.
Digitalisation of existing QMS
Transitioning paper-based quality management systems into streamlined, compliant digital workflows.
Compliance strategies for Sch. M, EU, Anvisa, PMDA, MHRA and USA
Strategic regulatory guidance and multi-jurisdictional compliance roadmaps.
Green field project execution
End-to-end design, commissioning, tech transfer, and execution for greenfield API and drug product facilities.
Guidance on Regulatory Observations
Expert analysis, root-cause evaluation, and response strategy for Form 483s, Warning Letters, and non-compliance notices.
Frequently asked questions
What services does Firmamentum offer?
Firmamentum provides twelve pharmaceutical quality and regulatory disciplines: training, supplier development & qualification, QMS health checks, investigation report review, SOP development, batch production record review, internal audits, study protocol preparation, QMS digitalisation, multi-jurisdictional compliance strategy, greenfield project execution, and guidance on regulatory observations.
Which regulatory standards does Firmamentum help companies comply with?
Firmamentum works to USFDA, WHO, MHRA, ANVISA, PMDA, TGA, and Indian Schedule M standards.
Who leads Firmamentum's consulting engagements?
Engagements are led directly by Firmamentum's senior practitioners, who have held quality leadership roles at Sun Pharma, Cipla, Mylan, Dr. Reddy's, Akums, Lupin, Dabur, and Aurobindo.
Where is Firmamentum based?
Firmamentum Consultancy Services is based in Lucknow, Uttar Pradesh, India, and was founded in 2018 in Dehradun.