Analytical and CMC Consulting Services for Biopharmaceutical Industry
WHAT WE DO
Offering specialized Analytical and CMC consulting services tailored for biopharmaceutical organizations. Services encompass comprehensive lifecycle management for analytical methodologies, formulation of analytical strategies, preparation of technical reports, and the interpretation of data, all designed to enhance regulatory compliance and operational efficiency within biopharmaceutical organizations.
OUR SERVICES
Documents and Data Analysis
- Comprehensive policies and procedures.
- Analysis and interpretation of complex analytical data for elucidation critical quality attributes of biopharmaceutical products
- Technical reports and Module 3 sections for product characterization, comparability, method descriptions, method validation, reference standards, stability, and justification of specifications.
- Preparation of post-approval license supplements
QC Laboratory Support
- Inspection and audit readiness for Quality Control Laboratories
- Establishment and management of critical reagents and reference standard programs
- Analytical Method Establishment Strategies: Verification, Qualification, Validation and Transfers
Coach and Advisor
Coach and Advisor
- Coaching and advisory services for scientific staff to effectively formulate responses to inquiries from Health Authorities (HAs) and to participate in consultation meetings, such as FDA Type B/C and EMA Type I/II meetings.