Manufacturing Services

• Products category: Our analytical team has the expertise and advanced tools to handle various products like heterocyclics, carbohydrates, peptides, PEGs, proteins, polymers, oligonucleotides, and non-chromophoric compounds, etc
• Material category: We develop methods and perform thorough testing and qualification of raw materials, solvents, to meet regulatory standards and ensure quality
• Process category: Develop methods for reaction in-process testing, intermediates, and drug substances to maintain the consistent quality. We also develop cleaning processes to prevent cross-contamination
• Impurities: Develop mostly a single method to track impurities along with all materials for thorough process development
• Genotoxic impurities: We are capable of developing methods for the estimation of Genotoxic impurities and Nitrosamines to ensure the quality of the product and meet the regulatory requirements
• Method validations: Perform extensive method validation for all GMP stages

Impurities generated during the degradation studies will be identified, characterized, and quantified using advanced analytical techniques. This information will support the establishment of impurity specifications, with the goal of providing a scientific rationale for relaxing impurity limits where appropriate. This approach ensures alignment with regulatory expectations while maintaining the safety, efficacy, and quality of the drug substance.

• Chemveda has excellent infrastructure and expertise to establish the shelf life and the packaging conditions under various stability conditions (long-term and accelerated) appropriate for the API or the drug product which is essential for regulatory filings
• Walk-in Stability chambers (1000 L – 2000 L capacity) comply with 21 CFR part 11 regulations and covers all climatic zones. These studies support the determination of shelf life, storage conditions, and packaging specifications

Available storage conditions:

• 25°C ± 2°C;60% RH ± 5% RH
• 30°C ± 2°C;65% RH ± 5% RH
• 40°C ± 2°C;75% RH ± 5% RH
• 5°C ± 3°C
• -20°C ± 5°C
• Photostability chamber

• Our analytical team is skilled in separating enantiomers, diastereomers, and removing impurities to achieve high-purity products, which are vital for drug efficacy and safety
• We can purify material from milligram scale to multi-kilogram scale using a wide range of preparative columns and high-end equipment like semi-preparative HPLC, SFC, and preparative systems with Dynamic Axial Compression (DAC) columns

Forced degradation studies of the drug substance will be conducted in accordance with ICH and ANVISA guidelines. These studies will provide a comprehensive understanding of the product’s stability and its degradation pathways under various stress conditions, including heat, light, oxidation, and hydrolysis. This approach ensures the development of a robust stability profile for the drug substance.

Expertise in handling the analytical method validations as per the regulatory guidelines like ICH and ANVISA, also offer method verifications to confirm the applicability and consistency of third-party methods in our facilities.

Our Quality Management System (QMS) is designed to ensure the highest standards of quality and compliance throughout our operations.

• We follow GMP principles to ensure quality, reliability, and integrity in all processes
• Standard Operating Procedures (SOPs) are in place to standardize operations, ensuring consistency and compliance
• Empower-3 servers are used for advanced chromatographic techniques, ensuring precise data analysis and secure data storage