Our Services

Beachside Compliance Solutions (BSC) specializes in delivering comprehensive, science-driven support across the full spectrum of Analytical and Chemistry, Manufacturing, and Controls (CMC) development. BSC’s services are designed to meet the rigorous expectations of global regulatory authorities such as ICH, FDA, and EMA. The firm focuses on promoting data integrity, regulatory compliance, and scientific excellence in every engagement.

Comprehensive Analytical & CMC Strategy

Regulatory SOPs & Data Integrity

Analytical Insights & CQA Profiling

  • Development of SOPs aligned with ICH, FDA, and EMA guidelines

    Integration of data integrity principles and audit trail requirements

    Lifecycle management of analytical methods and reagents

  • Elucidation of Critical Quality Attributes (CQAs) using advanced analytical techniques (e.g., LC-MS, CE, NMR)

    Statistical evaluation of method performance and product comparability

    Trending and interpretation of stability data to support shelf-life claims

Technical Submissions & QA Strategy

  • Product Characterization: Structural and functional analysis of biologics

    Comparability: Demonstration of equivalence post-manufacturing changes

    Method Descriptions & Validation: Detailed protocols and validation summaries

    Reference Standards & Specifications: Justification of acceptance criteria and control strategies

    Stability: Protocols, data summaries, and extrapolation mode Post-Approval Supplements

    Preparation of CBE-30, PAS, or Annual Reports

    Impact assessments and risk-based justifications for changes

  • Gap assessments and mock audits

    Training programs and documentation reviews

    CAPA implementation for observed deficiencies 

    Reagent & Reference Standard Management

    Qualification and lifecycle tracking of critical reagents

    Establishment of traceable reference standard programs

QC Laboratory Support & Readiness

Documentation & Submissions

Driving Data Integrity Through Every Phase

Our analytical method lifecycle approach ensures scientific precision, regulatory compliance, and cross-functional alignment.

From initial qualification to final method transfer, we help streamline every stage of the analytical process to ensure reproducibility, accuracy, and audit-readiness.

  • Qualification

    Validation

    Verification

    Transfer

  • Confirm method suitability in new lab

    Ensure method meets intended purpose

    Full assessment of method performance

    Reproducibility across sites/labs

    • System suitability

    • Limited performance checks

    • Intermediate validation

    • Robustness testing

    • Specificity

    • Linearity

    • Comparative testing

    • Training

    • Accuracy

    • Precision

Schedule a Consultation

Ready to discuss your analytical or regulatory strategy needs? Schedule a consultation.