WHAT WE OFFER
Analytical Laboratory Planning and Setup
We help the firm in designing the analytical laboratory as per the volume and type of activities planned. The design shall be created to meet regulatory expectations. We also support in planning the entire analytical activity workflow; qualification of instruments and equipment; developing of QMS and initiate the laboratory functions.
GMP / GLP Consultancy Services
GMP / GLP Standards are based on International guidelines (ICH; ISO 9001:2015; WHO; USFDA; TGA; EMA; MHRA; AVP / EU GMP Annex 11; PDA; ISPE GAMP; OECD). Although GMP and GLP look very similar, but their regulations differ in many aspects. GLP regulations expect data integrity of the research work done, whereas GMP expects from the company to demonstration that all activities were performed as per pre-approved protocols and procedures. As per ICH Q10, appropriate amount of GMP is required to be implemented in developmental area.
Analytical Laboratory Compliance
We support the firm in developing Quality management systems applicable for both manual and automated systems with appropriate controls to maintain data integrity and security. We perform the complete compliance assessment as per ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) and provide the appropriate solution.
Regulatory support for filling Dossiers
We support in collating data for DMF and ANDA and make the dossier as per the FDA format for submission.
Quality Function & Documentation
Quality documentation specially focus on optimizing and linking the entire documentation of the company in most appropriate way. It also include designing protocols for various studies such as method validations, stability management, forced degradation, developmental studies etc.; developing work breakdown structure; implementing tools and techniques for performance evaluation and improvement etc.
Software and Computer System Validation (CSV)
We provide support to perform the Computer system validation and software validation in compliance with regulations defined in 21 CFR part 11, GAMP, TGA and EU guidelines. Our services includes designing the validation protocol, assessment of the software, security validation, training on validation process, and documentation. The extent of validation depends on type of software and its intended use.
Audits and Audit preparedness
We perform vendor audits and contract laboratory audits for the firm required for vendor qualification. We also perform GMP audit and mock-FDA audits for the firm; impart training for audit preparedness focussing mainly on USFDA, MHRA, WHO, Anvisa (Brazil) & TGA inspections.
Qualifications & Validations
We provide complete qualification support for Instrument and equipment; area; utilities and HVAC System of manufacturing plant and development laboratories.
We provide classroom trainings and interactive workshops on various topics including team building; leadership; GMP and GLP guidelines; Analytical techniques; validations & qualifications; Instrumentations; Investigation of non-conformances; QMS; Impurities etc.
We can manage your projects in all areas (manufacturing, technology transfer, development etc.) and provide quality deliverables timely within your budget. We also provide trainings to develop project managers within your team.
Investigation of Non-conformances
We work with the client to investigate OOS/OOT results attributed to analytical laboratory and/or manufacturing errors. We also provide the insights to any investigation; develop investigation flow charts and checklist; impart trainings on root cause analysis using multiple case studies