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Our Services

Transformative Regulatory & Compliance Solutions with AI Precision

Empowering Biopharma Across the Full Development Lifecycle

Clinplex partners with biopharma organizations from discovery to commercialization, delivering next-generation regulatory, quality, and operational solutions. Our approach accelerates development timelines, reduces compliance risk, and strengthens quality outcomes—ensuring therapies reach patients faster, safer, and smarter.

From Discovery to Delivery: Accelerating Therapeutic Innovation

We drive end-to-end development of drugs, vaccines, and biologics—from preclinical strategy through IND, NDA, and BLA submissions to commercial readiness.

Assay validation and regulatory pathway optimization
CMC lifecycle management and scale-up strategy
Submission readiness with proactive health authority engagement

GxP Training & Compliance Readiness

Clinplex equips teams with role-specific, audit-ready training across cGMP, GCP, GLP, and cGxP. Our scalable programs combine regulatory intelligence, risk mitigation, and real-world application, ensuring every function—QA, manufacturing, clinical, and preclinical—is aligned with global compliance standards.

Advanced Quality Assurance & Risk-Based Compliance

We design and deploy scalable, inspection-ready QMS aligned with FDA, EMA, WHO, and ISO requirements. Our solutions feature:

Integrated CAPA intelligence and risk-prioritized controls
Digital audit trails and proactive monitoring
Demonstrated impact: up to 30% reduction in compliance deviations across clinical and manufacturing operations

Data Analytics & Real-World Evidence

Using Power BI, Tableau, and advanced RWE frameworks, we turn complex data into actionable insights. Clinplex strengthens product value stories for regulators, payers, and providers—ensuring data-backed decision-making across the product lifecycle.

Regulatory Affairs with Precision Execution

Clinplex ensures 100% on-time delivery of regulatory submissions, navigating FDA, EMA, and ICH frameworks with precision. Our team drives:

IND/NDA/BLA submissions with phase-appropriate strategy
Module development and pre-submission agency communications
Lifecycle compliance management from preclinical through post-market

Clinical Operations & Strategic Program Execution

We integrate Agile, hybrid, and stage-gated methodologies to ensure cross-functional program success. Clinplex enables:

On-time, on-budget delivery of complex clinical programs
End-to-end oversight across development phases
Alignment with global regulatory and operational standards

Integrated Clinical & Laboratory Systems

Clinplex architects digital ecosystems that unify EMR, LIMS, eSource, and real-time data platforms—driving interoperability, compliance, and precision-driven outcomes.