Services
GMP Consultancy
We use our expertise in successful execution of GMP inspections for various Health Authorities. Our service covers:
- Complete Gap Analysis in the aspect of QMS and Facility to meet Regulatory expectation.
- Guidance to comply the deficiencies outcome during gap analysis.
- Guidance to trigger inspection (EU-GMP/PICs/TGA/Ethiopia/Uganda/Kenya/Zimbabwe) at site.
- Guidance for Application filling to health authority.
- Guidance for site transfer project.
- Guidance for site variation filling.
- Guidance for preparation of CAPA in the aspect of received deficiency from agency and customer.
- Establishing the QMS system in view to meet international regulatory requirements.
- Guidance for equipment/instrument Qualification as per 21 CFR compliance/Annexure-11.
- Guidance for PLC/ERP/SAP system validation.
- Arrange mock up audit from EU-QP prior to regulatory inspection or after registration of the products.
Dossier Consultancy
We use our expertise to review and compliance all the technical package which is required for dossier preparation in CTD/ACTD and eCTD format and submit to MAA/US-FDA/ANVIZA/TGA/MCC/PICS SAHPRA etc.
- Guidance for identify the Bioequivalence center to conduct BE/BA study.
- Guidance for BE/BA study monitoring.
- Review and compliance of CMC documents.
- Guidance for clinical and non clinical study.
- Dossier preparation in CTD and eCTD format.
- DMF Preparation and filling.
- Guidance for Dossier submission their respective authorities.
- Guidance for RFI and prepare the response against RFI.
GMP Audit
We use our expertise to third party audit, mock regulatory audit.
- Perform third party audit for API/Excipient/primary packaging materials manufacture/supplier based on customer recommendation. Responsible for audit report preparation/compliance and closure.
- Perform third party audit for contract lab. Responsible for audit report preparation/compliance and closure.
- Perform third party audit for bioequivalence site. Responsible for audit report preparation/compliance and closure.
- Perform third party audit prior to execute regulatory submission batches. Responsible for audit report preparation/compliance and closure.
- Perform mock audit at manufacturing site before regulatory inspection. Responsible for audit report preparation/compliance and closure.
Analytical Development
Analytical Services
- Guidance for analytical method validation
- Guidance for cleaning validation
- Guidance for microbial limit test method validation
Formulation Development
We use our expertise in successful execution of GMP inspections for various Health Authorities. Our service covers:
- Guidance to selection CRO and conduct formulation development for Injectable/Solid Oral
- Guidance for RLD arrangement from their respective markets.
- Guidance for Development Report as per ICH Q-8
- Guidance for QBD formulation development
- Guidance for dissolution profile
- Guidance to selection laboratory to conduct membrane filter validation
Plant Design & Setup Consultancy
SPM provide consulting services in the area of plant set up, new facility design and erection/up-gradation of all manufacturing facility of all drug product all dosage form. Gap analysis for existing facility, systems and procedures and up gradation solution to meet stringent regulatory norms
Equipment Qualification & Validation
Qualification and Validation services starting from Designing of URS/DQ/FAT/IQ/OQ and PQ. Cleaning validation solutions.