PRODUCT & SERVICES
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PRODUCTS FOR DEVELOPMENT & SERVICES OFFERED:
1. Chemistry Skill Set
Corvid Pharma offer a comprehensive range of chemistries and reaction capabilities across all scales within the small & large molecule domain. Some of the key chemistry and reaction capabilities are provided below :
• Alkylation, Acylations
• Azide formation and Carbonylations
• Catalytic reductions
• Column Chromatography for purifications
• Grignard Reaction
• High pressure reactions (~25kg)
• Hydrogenations
• Low temperature reactions(-50deg C)
• Moisture sensitive reactions
• N-aminations, Nitrations
• Organometallic catalytic reactions (Air and moisture sensitive)
• Peptide synthesis - Solid and solution phase
• Suzuki coupling
• Stereo selective and Chiral resolutions
2. Formulation Dosage forms
Oral Dosage
• Capsules
• Tablets (coated & uncoated)
• Tablets ( extended release )
• Effervescent tablets and powders
• Orally Disintegrating Tablets (ODT)
• Granules and Powders
Creams & Ointments
Parenteral ( LVP,SVP)
• Solutions (vials and pre-filled syringes)
• Lyophilized (vials)
• Suspensions
• Emulsions
Liquids
• Solutions
• Suspensions
• Syrups
Niche :
• Depot injections
• Peptide parenterals
3. Quality Control :
A. Analytical Development
Corvid offers a comprehensive package of analytical services to support your product development and marketed product activities.
• Stability Testing
• Finished Product Testing
• Pharmaceutical Testing (USP, EP, JP, BP)
• Process contaminants,excipients,impurities,degradents
• Raw Material Testing
B. Analytical Services
• Stability indicating method development, validation and tech- transfer at the manufacturing site.
• Drug substance / reference standard characterization and qualification.
• Isolation and complete characterization of impurities.
• Comprehensive stability studies for target API's.
• Pharmacopeia methods verification for target API's.
• Forced degradation studies.
C. Stability Studies
Corvid provides complete stability testing and storage services for your product, in all ICH conditions, as well as custom conditions.
• ANDA stability testing
• Formulation prototype stability
• Method transfer and qualification
• Stability protocol generation
• Stability data compilation
• Sample storage
• Statistical evaluation of stability data
D. Stability storage
At Corvid, Stability studies are routinely performed at various time points under conditions of different temperature and humidity
( Real time, Accelerated and Stress studies as per ICH guidelines). Storage conditions meet the ICH standards including :
• 25°C/60%RH
• 30°C/65%RH
• 40°C/75%RH
• 2°C – 8°C
• Light (controlled humidity)
4. Regulatory Support
Corvid, has expertise in quality, compliance and regulatory affairs in both eastern and western markets. Our Quality group offers regulatory support and assistance for :
• EMA guidance
• USFDA guidelines
• ICH Guidance
• DMF & Drug dossier preparation