Spoc Scientifics

Techno-Scientific Consultation Services

Techno-Scientific Consultation

Empowering Pharmaceutical Innovation with Expert Analytical & Regulatory Support 
SPOC SCIENTIFICS is proud to expand beyond product sourcing into specialized technical consulting services for the pharmaceutical industry. Backed by experienced domain experts, we now provide a robust suite of analytical, regulatory, and risk management solutions to support your R&D, quality, and compliance workflows. Whether you’re developing new formulations, addressing regulatory queries, or managing complex analytical challenges, our team offers deep insights and hands-on support to help you navigate each step with confidence. 

Our Expertise

Analytical method optimization and troubleshooting.

Expertise in LC-MS, GC-MS, HRMS, and chromatography challenges.

GAP analysis, data review, and risk mitigation planning (Analytical & Stability).

GAP analysis, data review, and risk mitigation planning (Analytical & Stability).

Structural elucidation using Mass Spectrometry and NMR.

Mass Spectrometry expert support for troubleshooting and audits.

Analytical method optimization and troubleshooting.

Design of Experiments (DoE) for method development.

Nitrosamine risk assessment and remediation strategies.

Extractables & Leachables (E&L) study design and data review.

VOC, NVOC, and SVOC study planning and interpretation.

Identification of unknown impurities and non-target analytes.

Prediction and assessment of leachables and degradation products.

Method development & validation for nitrosamines and trace analytes.

Technical consultation for analytical remediation activities.

Quality data review for technology transfer and compliance.

All documentation support for Analytical / QC- GMP protocols & reports preparation.

Support for regulatory submissions and response to analytical queries.

Why Choose US

Our consulting division is designed to work alongside your Technical, QA, and regulatory teams — providing specialist inputs that enhance data quality, reduce delays, and support regulatory readiness.

What You Can Expect

Efficient coordination with accredited labs

Accurate data generation & interpretation

Expert-led project handling and troubleshooting

Audit-ready documentation and technical summaries

Deep scientific insight for decision-making

Execution ModEl

Strategic Collaborations with Accredited Labs

We partner with well-established, regulatory-compliant laboratories (GLP, NABL, ISO, WHO-GMP certified) to execute all experimental work, method development, and technical data generation. These labs ensure that every report, result, and document meets the highest industry and regulatory standards. 

SPOC SCIENTIFICS-Led Scientific Oversight & Liaison

SPOC SCIENTIFICS acts as your technical liaison and project coordinator, offering continuous support, query handling, and technical interpretation through our expert team of experienced technocrats and scientific consultants. 

Domain Expertise-Driven Support

Every scope area — whether it’s analytical chemistry, nitrosamine risk assessment, impurity profiling, extractables/leachables, or regulatory submissions — is managed by specialists with deep industry experience. Our team includes former R&D heads, analytical experts, and mass spectrometry professionals. 

End-to-End Documentation & Regulatory Readiness

All deliverables are vetted for regulatory compliance (ICH, USFDA, EMA, CDSCO). We provide guidance, interpretation, and documentation review to ensure that your filings and responses are accurate and audit-ready. 

Integrated & Flexible Consulting

We act as a single-window solution across project stages — from planning to execution to submission. Clients benefit from our centralized communication, cost-efficiency, and technical accountability. 

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