Our consulting services

Combination of technical expertise & regulatory proficiency enabling swift & efficient product pathway up to registration

Phase-appropriate documentation and submission module 3 support

• Comparability protocols/ reports

• L&E/ nitrosamine, melamine and animal origin materials risk assessments

• BLA compilation/ review (manufacturing and analytics parts)

• Viral clearance validation design

• Cell bank characterization and traceability

Pharmaceutical Development Strategy

• Defining Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)

• Process FMEA preparation and review

• Process control strategy preparation and review

Technical process management

• Facility fit evaluation

• Technology transfer and scale-up support

• CDMO selection

Person in Place (PiP) services

Bioprocess consulting

De novo and biosimilar products development strategy preparation: time and cost efficiency in process development and/or optimization activities with phase appropriate risk management strategy.

Support in process development strategy preparation considering QbD principles and scalability, support during execution, data review, reports preparation

• Cell line, production process, formulation development

• Production process optimization and adoption for facility and equipment at receiving site

• Scale up and technology transfer to production facility strategy development

• Impurity clearance studies set up and oversight

Support in characterization studies design, planning, execution, data review and reports preparation

• Cell bank characterization

• Product & process characterization

• Process and product related impurities characterization

• SDM & SDMQ design

Existing process assessment and provision of improvement recommendations

CMC consulting

(Biosimilars & Innovative)

Analytical consulting

Science – risk-based approach to method development and regulatory sound approach to method qualification/validation, transfer & life cycle management: process and analytics bridging starting from QTPP to submission strategy

Analytical method development

• Support in selection of analytical technologies

• Analytical method development strategy preparation for biologics

• Support in integration of analytical control strategy

Analytical method qualification and validation

• Support in assay qualification and validation strategy and plans preparation

• Support in preparation of bridging and compatibility assessment plans

Analytical method transfer

• Analytical methods transfer strategy preparation and technical oversight of activities

• Support in coordination between transferring and receiving sites

Analytical method lifecycle management

• Continuous performance monitoring and trending, methods review and improvement recommendations

• Support in integration into overall product life-cycle management

GMP consulting

Provides expert support to ensure consistent process and product quality. Our experience across diverse company sizes and maturities, combined with deep understanding of process-facility alignment, enables technically robust and commercially viable outcomes.

Facility and Equipment Design & Qualification

• GMP-compliant layout planning for cleanrooms, labs, and production suites

• URS, DQ, IQ/OQ/PQ documentation and execution

• HVAC, water systems, and environmental monitoring setup

Process Performance Qualification (PPQ) & Control

• Validation Master Plans (VMP) and lifecycle strategies

• Cleaning validation; media holds and aseptic process simulation (media fills)

• Continued Process Verification (CPV) and trending

Computer System Validation (CSV)

• 21 CFR Part 11 compliance

• Validation of EQM and LIMS systems

Vendor Qualification

GMP audits of raw material suppliers and CMOs

Facility & Engineering consulting

Science – risk-based approach to method development and regulatory sound approach to method qualification/validation, transfer & life cycle management: process and analytics bridging starting from QTPP to submission strategy

Facility design

• Conceptual and basic design for mammalian, microbial, and gene therapy facilities

• Laboratory layout and engineering documentation support

• Facility expansion and critical systems assessments

• Validation, calibration and preventive maintenance plans and strategies

Support with engineering & validation documentation preparation, review and assessment for critical systems, equipment and computerized systems

• Validation, Calibration and Preventive Maintenance SOPs

• Validation specifications, RAs, protocols and reports

• Commissioning & decommissioning protocols

• Facility and critical system drawings (layouts, schematics, P&IDs)

• Engineering files for critical systems

• Validation, Calibration and Preventive Maintenance system assessments and improvements

Representation during FATs. Supervision of engineering and validation activities

Quality Consulting

Application of best practices in quality management to ensure compliance & regulatory expectations: Fit for purpose quality support from development stage up to commercial operations.

Temporary support of key quality functions (in preparation or remediation after audits)

• Support/lead quality events (DEV, CAPA, Change Control) and root-cause investigations​

• EMA/FDA readiness assessments, routine GMP audits and suppliers' qualification​

• Remediation plans and CAPA execution to effectively address deficiencies identified during regulatory audits

Quality system design (QA/QC) - QMS establishment & continuous improvement​

• eQMS and LIMS selection and implementation​

• Electronic batch records development and implementation​

• GxP documentation and Computerized systems compliance assessment & improvements according to Data Integrity principles​

Site Contamination Control Strategy / Assessment and Cross-contamination control​

Business strategy & supply chain consulting

Strategy begins with a robust business case – grounded in financial viability, market dynamics, and a clear path to scalable growth.

Scalable operations rely on robust planning, automated systems, and industrially proven processes to deliver resilient, efficient supply chains across global markets.

Business strategy

• Business case development

• Financial estimations

• NPV, ROI, IRR and EV development

• Facility investment evaluation

Supply chain consulting

• S&OP processes establishment

• Value chain process analysis and optimization

• Capacity optimization

• Operational excellence implementation

• Integrated demand, planning and supply solutions

• CMO management support

Contact us

We cover client needs from facility design to product commercialization