Orvera Scientific
Orvera Scientific Ltd. provides consulting services to leading companies in the pharmaceutical and biotechnology industry, focusing on validation, quality assurance, risk management, microbiological control, sterility assurance, regulatory dossier support, and education. They serve clients involved in drug substance manufacturing, sterile dosage forms, cell therapy, ophthalmics, and parenteral products, aiming to help them reach their business and product goals with scientific rigor and patient benefit in mind.
Industries
Nr. of Employees
small (1-50)
Services
Support for process design, aseptic reliability assessments, media fill expertise, regulatory dossier authoring and process improvement to maintain product sterility.
Design or revitalization of validation programs across laboratory methods, equipment, facilities, sterilization and process validations.
Development and improvement of pharmaceutical quality systems and delivery of audits including mock pre‑approval, GMP and supplier audits; inspection readiness support.
Risk‑based assessment and implementation support to reduce microbiological contamination risk in upstream manufacturing and low‑bioburden processes.
Application of quality risk management tools and Quality by Design to guide product development and reduce unnecessary validation.
Tailored training sessions delivered to client facilities covering basic microbiology, sterilization, depyrogenation, cleaning and disinfection and other aseptic processing topics.
Support for process design, aseptic reliability assessments, media fill expertise, regulatory dossier authoring and process improvement to maintain product sterility.
Design or revitalization of validation programs across laboratory methods, equipment, facilities, sterilization and process validations.
Development and improvement of pharmaceutical quality systems and delivery of audits including mock pre‑approval, GMP and supplier audits; inspection readiness support.
Risk‑based assessment and implementation support to reduce microbiological contamination risk in upstream manufacturing and low‑bioburden processes.
Application of quality risk management tools and Quality by Design to guide product development and reduce unnecessary validation.
Tailored training sessions delivered to client facilities covering basic microbiology, sterilization, depyrogenation, cleaning and disinfection and other aseptic processing topics.
Expertise Areas
- Sterility assurance
- Aseptic manufacturing and fill‑finish
- Validation program development
- Microbiological control
Key Technologies
- Steam sterilization
- Dry heat sterilization
- Depyrogenation
- Irradiation sterilization