Analytical Services
Robust Methods to ensure quality of drug product.
Concresco Pharma consider the specific needs of your project and your analytical challenge, and tailor for you the most suitable analytical strategy and methods. Our analytical scientists have unmatched know-how in their field and able to push the limits of what’s possible.
Concresco is committed to customers by adopting defined procedures, methods, employing qualified and efficient personnel towards achieving reliable and quality results in time.
All personnel concerned with testing activities within the laboratory familiarize themselves with quality documentation and implement the policies and procedures in their work.
Method Development
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Method capabilities: Expertise in method verification, development, and validation for a range of analytical methods including assay, impurities, dissolution, water by KF, and identification.
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Pharmacopeia methods: Verification conducted for identification tests as per pharmacopeial standards.
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Equipment mapping: After mapping equipment at manufacturing facilities, suitable residue methods will be developed and validated.
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Reference standards: Generation and qualification of appropriate quantities of reference standards to support analysis and method transfers.
Stability Studies
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Stability studies: Conducted for developmental drug products following ICH guidelines.
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Conditions tested: Long term, intermediate, and accelerated conditions in various packaging formats as needed.
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Additional studies offered: Short-term temperature exposure, photostability, and in-use stability studies.
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Equipment available: Stability chambers, refrigerators, and deep freezers tailored to different climatic zone requirements.
Method Validation
Method validation executed as per the well-defined phase appropriate SOPs which are in line with the current regulatory, ICH guidelines in accordance to cGMP requirements.
Reverse Engineering Capabilities
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Our characterization services for generics help assess the quality characteristics of drug products to determine the formulation composition of the Reference Drug.
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We help to understand physical, chemical characteristics to ensure the desired QTTP. We have expertise in Q1, Q2 and Q3 characterization of reference product.
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To do so, analytical expertise is required, and not all companies are having with these capabilities. With our expertise and collaborating with partners for sophisticated instrumentations we can provide these capabilities.
Why Concresco ?
Innovative Product Development
Dosage Form Proficiency
Global Expertise
ExperiencedLeadership Team
