Company Profile

Sourcing Inquiry Logo Explora Laboratories SA

Explora Laboratories SA

Regions
Europe
Countries
Switzerland
Size
n.e.
Specialty
Biopharmaceuticals
Service category
Contract manufacturing, filling and packaging, Pharmaceutical process development and validation, …
Service category
Contract manufacturing, filling and packaging, Pharmaceutical process development and validation, Pre-clinical development and testing, pre-clinical CRO, Regulatory services - CMC writing - medical writing, Sourcing of APIs, Excipients, Intermediates, bulk drugs
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Key services

Services

Services

  • Feasibility Studies
  • Bibliographic and Literature Search
  • Laboratory Custom Synthesis and Scale - Up
  • Regulatory support (DMF - GMP - FDA)
  • Identification, Preparation and Isolation of Related Substances
  • Process Development for New Synthetic Routes
  • Manufacturing Process Optimization for Generic Drug Substances
  • Evaluation of Critical Points and Assistance for the Process Validation
  • Research and Custom Synthesis Project Management

 

Custom Synthesis

Custom synthesis projects are carried out at Explora Laboratories partners' facilities. All these production sites work in compliance with cGMP and many of them are also FDA inspected.

Our QA & Regulatory Affairs Department assures the GMP compliance of each custom synthesis project.

Custom synthesis projects are carried out on exclusivity agreement and the confidentiality is guaranteed by ad-hoc secrecy agreement

 

Analytical Department

Our analytical laboratory allows us to provide following services:

  • Development of Analytical Monograph for New Drug Substances and Molecules Coming Off Patent
  • Development and Validation of Test Methods for Drug Substances
  • Development and Validation of Methods for In-process Controls
  • Development of Specifications for Raw Materials and Key Intermediates

Regulatory affairs

Explora Laboratories SA has its own Regulatory Affairs Department, which provides all assistance necessary both for issuing and filing technical documentation (CTD and Certificate of Suitability). We are able to provide to the customers all necessary assistance for the registration of generic products.

Approvals, Certificates, Authorisations

  • FDA

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