Validation & Quality Services

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Ensuring your systems and processes are proven, traceable, and compliant

We provide end-to-end support for process and method validation, cleaning validation, and technology transfer—ensuring that every stage meets EU GMP, FDA (Stage 1–3 Process Validation), and ICH Q8/Q9/Q10 requirements. Our approach ensures systems and processes are reliable, compliant, and ready for regulatory scrutiny.

We also facilitate brand-to-contract manufacturing partnerships, bridging MAH holders and brand owners with fully compliant technology transfer, documentation, and execution strategies.

Our Services Include:

• Validation of various processes and analytical methods.
• Cleaning validation protocols and execution
• Stage 1–3 Process Validation lifecycle implementation
• Documentation as per global audit expectations
• Risk-based technology transfer protocols with traceability matrix
• TT strategy aligned with ICH Q10, ISPE, and FDA guidance
• Facilitation of MAH-to-brand manufacturing partnerships
   

Outcome: Validated, documented, and audit-ready processes with clear traceability, reduced variability, and minimal risk during commercial launch.

Expert guidance to maintain product sterility and process integrity

Sterile manufacturing environments demand the highest level of control and precision. We support the design, setup, and validation of aseptic processes in line with the updated EU GMP Annex 1 (2022) and FDA aseptic processing guidelines.

Consulting Areas Include:

• Aseptic facility and cleanroom design (Grade A/B)
• Barrier systems and isolator integration
• Sterilization process design:
  • Steam-in-Place (SIP)
  • Moist heat/autoclave
  • Dry heat depyrogenation
  • Sterile filtration validation
• Media fill (process simulation) protocol development
• Sterility assurance level (SAL) validation
• Support for visual inspection and container closure integrity (CCI)

Benefit: Robust aseptic operations that ensure product sterility and withstand global regulatory scrutiny.

Building contamination control strategies that protect your product and process

Microbial contamination can jeopardize product safety and compliance. We help companies establish risk-based microbial control strategies and environmental monitoring (EM) programs that meet the requirements of Annex 1, USP <1116>, and GAMP/GDP principles.

Key Support Areas:

• Design and qualification of environmental monitoring programs
• Microbial sampling plans for air, surfaces, and personnel
• Trending, alert/action limit setting, and deviation management
• Cleanroom behavior and gowning compliance training
• Rapid microbiology methods (RMM) integration
• Establishment of contamination control strategy (CCS) as per Annex  
• Root cause investigation for excursions and contamination events
   

Result: A scientifically justified EM program that ensures continuous compliance and supports product quality assurance.

Preclinical study guidance and GLP system setup to support regulatory filings

Our team provides strategic and technical support for companies conducting or sponsoring preclinical safety and toxicology studies, especially those preparing for IND (US) or IMPD (EU) submissions. We also help establish or assess GLP-compliant systems based on OECD and national regulations.

Our GLP/Tox Services Include:

• GLP quality system setup and SOP design
• CRO/vendor qualification for tox studies
• Study design review and protocol evaluation
• Raw data verification and report integrity checks
• IND/IMPD documentation support (non-clinical section)
• Regulatory advisory for preclinical dossier readiness
   

Advantage: Ensure your early-phase development is scientifically sound, regulatorily compliant, and ready for global submissions.