Development and implementation of analytical methods

We develop, qualify, and implement analytical methods that are regulatorily robust and economically scalable.

– State-of-the-Art Bioanalytical Platform
– Structured Method Development for Every Project Phase
– From early feasibility testing to transfer-ready methods,
we deliver robust data packages – predictable, auditable,
and partner-ready.

Operational success – rigorous regulatory scrutiny

Core Analytical Services

Core Analytical Services
– Matrix Evaluation & Feasibility Assessment: Ensuring early-stage viability.
– Method Development & Target Alignment: Precise calibration to project goals.
– Performance Optimization: Enhancing sensitivity, specificity, and robustness.
– Assay Qualification according to ICH Q14: High-level international standards.
– Bridging & Comparative Studies: Seamless transition between project stages.
– Preparation for Regulatory Validation (ICH Q2-ready): Strategic alignment with official requirements.

Value for Our Partners:
– Reduced Development Risk: Through scientifically sound methodology.
– Early-Stage Decision Support: Providing a solid data foundation.
– Transferable SOP Structures: Ready for immediate implementation.
– Scalability in GMP Environments: Ensuring future-proof results.

Regulatorily Integrated Infrastructure – Globally Scalable

Our laboratory structure is designed not only for operational success but to rigorously withstand regulatory scrutiny.

Core Infrastructure Features:
– GLP and Non-GLP Environments: Versatile settings for diverse project needs.
– Auditable Quality Management System: Fully transparent and inspection-ready.
– Comprehensive SOP Architecture: Standardized excellence across all workflows.
– Documented Data-Integrity Processes: Ensuring the highest level of data reliability.
– GMP-proximal Production Environments: Bridging the gap to full-scale manufacturing.
– International Partner Network (incl. India): Strategic global presence for optimized reach.

Analytical Expertise – Technologically Broad, Strategically Focused

Our platform combines modern bioanalytics with structured project management.

Customized Services

Matrix Evaluation

Method Optimization

Method Development

Imaging & Characterization

Purity Assessment
Integrity Confirmation
Identity Confirmation
Impurity and Degradation Quantification

Aggregation & Stability

Stability Profiling
Aggregation Analysis
Fragmentation Studies

Functional Assays

Potency Evaluation
Binding Assays
Advanced Impurity Quantification

Project onboarding at PreviPharma

A clear process, defined deliverables, and full transparency so outsourcing becomes predictable.

Candidate & Baseline Assessment

Objective:
– Comprehensive understanding of the material, clinical indication, and existing database.

Deliverable:
– Project Launch Profile, including a detailed evaluation of current processes and analytical methods.

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Scope & Objectives

Objective:
– Defining goals, endpoints, timelines, quality requirements, and reporting structures.

Deliverable:
– Finalized Project Scope, including Key Performance Indicators (KPIs) and milestones.

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SOP-Check (Process / Method SOP)

Objective:
– Reviewing existing Standard Operating Procedures (SOPs) and identifying required additions.

Deliverable:
– Comprehensive SOP Map including a detailed Gap Analysis.

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Method Availability & Setup

Objective:
– Selection of available methods/assays, equipment compatibility check, and development of a comprehensive setup plan.

Deliverable:
– Method Setup Plan, including dedicated resource allocation and finalized timelines.

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Deliverables

Objective:
– Providing structured, audit-ready result packages.

Deliverables:
– Comprehensive Data Package, Qualification Report, specialized SOPs, Certificate of Analysis (CoA), and Control Charts.

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Bioequivalence & Comparability

Objective:
– Confirmation of comparability between batches, manufacturing sites, or analytical methods.

Deliverable:
– Formal Comparability Statement and documented scientific conclusions

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Final Discussion & Technology Transfer

Objective:
– Final review, assessment of transfer-readiness, and formal handover to subsequent project stages or partners.

Deliverable:
– Comprehensive Transfer Package and official project closure documentation.

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Talk to
Us.
Now.

We would be happy to provide you with further information and discuss the possibilities for cooperations with you.

Talk to us

PreviPharma GmbH

CUBEX41
Universitätsmedizin Mannheim, Haus 41

Theodor-Kutzer-Ufer 1–3
D-68167 Mannheim

Tel. +49 (0) 621 72 847 848
Mail moc.amrahpiverpobfsctd-309b9b@ofni

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