Tech Ops & Outsourcing

Success requires technical and quality standards that support operational efficiency and enable a company's strategy.

Larka gives a critical edge to BioPharma companies, Contract Services Providers or Equipment suppliers by improving all R&D, Analytical & Manufacturing operations, Processes & Equipment efficiency, and support functions.

Larka's outsourcing specialists also help Biotech & Pharma companies develop and execute outsourcing and supply strategies that fit with internal capabilities, clinical stages, CMC requirements, financing needs and external environment.

TechOps

Outsourcing Strategy

Out of 250 interviews performed last year with biotech and pharma clients, 82% highlighted that a robust outsourcing strategy had become crucial for a successful drug development and manufacturing. For nearly 30 years and through over 600 outsourcing strategies developed, Larka has been addressing the evolution and structural change of the outsourcing activities within the biotech and pharma industry over time. We have always made sure that we met the specific objectives of our clients, whether they are small biotech or large Pharma, as their challenges are radically different.

Outsourcing Strategy

Sourcing & External Supply

Findings of 860 interviews recently performed have shown that deficient sourcing processes were a major reason for failure in clinical phases and overcostly supply operations. Larka's sourcing specialists have been successfully delivering thousands of professional sourcing reports and recommendations, built on proven methodologies, highly calibrated data and proprietary benchmarks on CRO, CDMO, CMO or Equipment suppliers, to both early clinical phase biotech or large pharma players.

sourcing & External Supply

Technical Due-Diligence

Market opportunities, competitive advantages and organization abilities and capacities can be leveraged only if technical operations, technologies, equipment and quality systems can sustain the corporate strategy. Since 1993, Larka has been successfully conducting hundreds of Technical Due-Diligences to support acquisitions, investments, outsourcing activities or supply chain optimization. With nearly 30 years of due-diligences, Larka has become the most experienced consultancy firm in the BioPharma industry, with a unique ability to deliver Integrated Due-Diligence and full-potential vision that combines Commercial, Operational and Technical Due-Diligence.

Technical Due-Diligence

Operational Excellence

The Biotech and Pharma industry has been late in considering Operational Excellence. Yet, Operational Excellence is likely one of the most value creating levers today. Larka has faced and overcome operational challenges for over 25 years, leaving behind a legacy of best practices and holistic approaches to Operational Excellence. Our methods and concepts are designed to simplify, streamline and harmonize processes, optimize OEE - Operational Equipment Efficiency -, improve products and services quality, rationalize supply chain, and, finally, measure performance with a comprehensive set of KPIs.

Operationnal Excellence

Quality Management & Regulatory Compliance

Application of current Good Manufacturing Practice and validation processes are crucial, at all steps of the product lifecycle, from clinical phase I to commercial launch. Since 1993, Larka has been performing Quality audits and GMP compliance assessments, developing Quality Management Systems, policies and Standard Operating Procedures, preparing FDA inspections and also implementing training processes as well as developing quality risk management plans, among others.

Quality Management & Regulatory Compliance