Larka

Technical Operations

Larka's technical experts will take care of your operations regarding pharma or biological products - quality matters included.

 

Technical Operations


Larka scientific and technical expertise covers the whole R&D, scale-up and manufacturing process of a drug substance or drug product, whether it is small or large molecule, including quality management, CMC, and regulatory affairs.
 
 

Pharmaceuticals

From API process research through drug product manufacturing, we partner with you to deliver decision-driving consultancy along the development process:

  • API process research/route scouting
  • Synthesis route selection
  • Process development
  • Process robustness
  • Analytical method validation
  • Risk assessment
  • Drug Product formulation development
  • Manufacturing process optimisation/improvement
  • Tech transfer

Biopharmaceuticals

Our team is building and managing complete development programs of biologic drug substance and drug product, including quality, HSE, economics and throughput factors:

  • Strain or cell line development
  • Bioprocess development/Fermentation
  • DSP development and engineering
  • Analytical development
  • Process validation
  • Technology development
  • Fill & finish
  • Tech transfer

Quality & Regulatory Management

Larka provides expertise to solve any issue or challenge you may have throughout the entire supply chain, for biologics or small molecule, biosimilars, generics or innovators, in quality & regulatory compliance for products, equipment, facilities, utilities or processes:

  • QA/QC
  • Quality management system
  • CAPA
  • Quality by Design
  • Chemistry, Manufacturing, and Controls - CMC
  • Preparation and registration of dossiers
  • Regulatory issues
  • New equipment/process integration
  • GxP compliance
  • Training
  • Policy & SOP

 

Other Topics

 

Customer Experience

I Need An Experienced Project Manager.

PharmaCo just acquired a preclinical bio product and needs some support.

Solving Quality Issues.

Biotech identified a contamination of its fermentors.