Larka

Contract Dev & Mnfg

Leave Larka in charge of your outsourcing process, whether it is about small or large molecule, API or finished product. From CDMO identification to supply chain optimisation.

 

Contract Dev & Manufacturing


API and Finished Dosage Forms outsourcing - small or large molecule - has been Larka’s core expertise since 1993. Being the preferred partner of many Pharma & Biotech companies in this field, Larka will support your CDMO or Supplier sourcing & selection process.
 
 

CDMO Identification

Larka manages 90+ sourcing projects/year with a wide range of request - DS, DP, R&D, CTM, commercial manufacturing, and helps you identify your next CDMO Partners:

  • Global coverage: industrialised & Emerging countries
  • 2,500+ CDMOs & suppliers identified – drug substance & drug product
  • Exhaustive screening delivered under 3 weeks' timeframe
  • Detailed CDMO overview - legal status, headcount, turnover, POC, plant location, certifications, capabilities & capacities, special manufacturing or containment capabilities, future CAPEX, main customers, etc.

RFx Management

Based on its solid experience in RFx processes - 75+ RFIs & RFQs/RFPs managed per year, Larka's assistance in this field covers:

  • Strategic data acquisition while keeping your name confidential
  • Specific requirements that should be met by CDMO - mandatory and scoring
  • Qualitative, quantitative, and up-to-date information directly sourced from CDMOs or suppliers
  • Comparison matrix – quotation/proposal analysis
  • Larka's recommendations

Due Diligence

With 20+ due diligences conducted per year, Larka will assist you with:

  • Global assessment of CDMO structure:
    • Operations
    • HR
    • Financials
    • Customer Relationship
    • Project Management
    • Cultural Environment
  • On-site technical assessment: CDMO proposal Vs. on-site capabilities
  • Reviews of performance monitoring: KPIs, corrective and preventive actions

Site Audits

Site audits is a common field of expertise of Larka - around 25 projects per year - and usually cover:

  • All quality & regulatory data you need to assess your potential future partner
  • QA/QC throughout the entire supply chain
  • QbD
  • CAPA
  • Expertise in regulatory issues, new equipment integration, GxP compliance & processes
  • Training, policy & SOP review

Tech Transfer Support

Handling around 10 TT projects per year, Larka assists and advises you on your tech transfer process:

  • Senior experts dedicated to TT, ready to help throughout your entire project:
    • Data exchange & collection
    • Parallel comparison
    • Risk assessment
    • Implementation & validation
    • Continuous Improvement
  • Management of all the transfer stages including API, excipients, manufacturing, packaging, cleaning and validation processes

Supply Chain Optimisation

With a solid experience in this field - three projects handled only within the last two years, Larka assists you with your rationalisation issues:

  • Data Collection on products, manufacturing, supply, and future requirements
  • Data analysis and development of scenarios
  • Risk assessment, testing of scenarios and constraints, selection of preferred options
  • Data modelling and analysis of implementation costs and timescale
  • Implementation

 

Other Topics

 

Customer Experience

Exotic Capability Wanted!

BiopharmaCo is looking for a CDMO for its very particular product.

Exploring Outsourcing Options

PharmaCo having a sub-portfolio of 17 products needs to find outsourcing alternatives for cost optimisation.

Quality Matters.

Biotech needs to know more about quality standards of its future CDMO partner.

Need For Optimisation...

PharmaCo wishes to optimise its manufacturing & supply network.