QAR Solutions B.V.

QAR Solutions is Founded and lead by Rajnish Chhabra, backed by more than three decades of experience working with large multi-national companies at various levels that include from being an operator to team lead to functional manager and eventually to assume Global responsibilities. Aiming to foster credibility and respect within the Pharmaceutical & Food industry. QAR Solutions is based on 3 core strengths: Quality • Establishing, reviewing, updating the Quality Management Systems for cGMP / GDP requirements as per ICH, EU, USFDA 21 CFR and ISO 9000 requirements. • Design, review and execute analytical validations, process validations. • Validations of automated systems, such as SAP, Trackwise, EDMS, RIMS as per GAMP guidelines. • GMP trainings / workshops. • Guidance in writing user’s guide and SOPs. • Tech transfers of API and drug product processes. Auditing • Performing due diligence / gap analysis / risk assessment / qualifications for: - Starting materials, intermediates, active pharmaceutical ingredient manufacturers, - Finished dosage form manufacturers, - Research and analytical laboratories, - Wholesale dealers & distribution centers • Pre-audit to prepare for health authority inspections and supporting in the preparations of the responses. • Routine audits for QMS as part of ongoing cGMP compliance reviews. Regulatory • Preparing the regulatory strategies for global registrations, including the emerging markets. • Preparing / reviewing ASMF/ DMFs for APIs (CEP, USFDA, ANVISA, SFDA, Korea, TGA etc.). • Preparing / reviewing ANDAs / Dossiers of drug products (oral applications) for USA / EU registrations. • Compilation and publishing dossiers, including paper and electronic submissions (eCTD, NeeS & ASEAN formats) • Trainings regarding the regulatory processes.