Documentation Services

Documentation Services

Analytical Development & Laboratory (ADL) Documentation: Preparation and review of AMV protocols and reports (AS, RS, DN, Residual Solvents, Swab Analysis), Method Development (MD) Reports, Comparative Dissolution Profile(CDP) Reports, Dissolution Development Reports, Nitrosamine & Elemental Risk Assessments, Residual Solvent Compliance Reports for drug product, SOPs, and more.

Reference: Successfully provided this service to our UK client, PrimeLabs.

Quality Control Documentation: Preparationand review of Specifications, Standard Testing Procedures (STP) for drug products and substances, Computer System Validation (CSV), Stability Reports, Trending Presentations for OOT, OOS, CAPA categorization, SOPs, and schedules for MCS & PMS.

Quality Assurance: SOP preparation and review, Incident Management, Change Control, Deviations, CAPA categorization, and related documentation.

Manufacturing Support: SOPs, Batch Manufacturing Records (BMR), Batch Processing Records (BPR), and related documentation.

Regulatory Services: Preparation, review, and submission of ANDA for finished products, PAS & CB-30 filings for any changes, and regulatory query responses in line with current guidelines.