We are a team of subject matter experts offering the following GxP services:
1. Vendor Audits (of Drug products, APIs, excipients and packaging material manufacturers).
2. Remediation and compliance preparation of regulatory audit observations.
3. Mock audits and Gap assessment for stringent regulatory inspections.
4. Gap assessment against EU GMP Annex-1.
5. Investigations, Root Cause Analysis, and CAPA implementation.
6. Designing Environmental monitoring program based on smoke studies for sterile facilities.
7. Sterility, BET, MLT Validations, Disinfectant efficacy test validation, Preservative Efficacy test validation.
8. Developing Aseptic process simulation (media fills) program and protocols for sterile dosage forms & Sterile APIs.
9. Developing Process Validation protocols for Solid & Liquid Oral Dosage Forms.
10. Developing Cleaning Validation program and protocols.
11. Training on GMP and Microbiology topics.
12. Policies, Standards, and SOPs preparations.

contact us at <bsgpharmaconsult@gmail.com>