SASAUR SOLUTIONS LLP

In their own words

Sasaur Solutions is a consulting organization aimed at providing comprehensive and cost-effective solutions to meet the Quality and Regulatory needs of pharmaceutical, biotechnology and medical device companies. Quality Assurance Services : • Build robust Quality management systems (QMS) tailored to any regulatory compliance strategy with fast turnaround time. • Analyze procedures based on client and product-specific requirements and develop/ review customized standard operating procedures (SOPs). • Implement virtual document control and record management for effective and traceable deployment of Quality systems • Integrate QMS to incorporate all elements of QC/QA/ manufacturing such as SOPs, policies, deviations, change control, out-of-specifications, CAPA, audits, training etc. in one place for increased productivity and efficiency. • Build a calibration and preventative maintenance program including review of calibration data for all equipment. • Develop validation protocols for qualifying rooms and equipment (IQ, OQ, PQ) used in GMP manufacturing. • 21 CFR Part 11 System compliance assessments and training, including electronic signatures and data integrity. • Build sampling plans and perform trend analysis. • Adherence to 21 CFR 210, 21 CFR 211, 21 CFR Part 820, ICH guidelines, FDA guidelines, GAMP 5, good manufacturing practices (GMP), good laboratory practices (GLP), good documentation practices (GDP) . • Adherence of Quality management systems to ISO 13485 and ISO 9001. • Remediation support in response to FDA 483s and warning letters and develop effective Corrective and preventive action (CAPA). • Develop vendor qualification program and assist in qualifying vendors for use in GMP manufacturing. • Develop and maintain inventory control program and database for raw materials, intermediates and final products used in manufacturing/ testing. • Review documentation related to QC/ QA/ manufacturing like batch records, material specifications, testing, deviations, change control, out-of-specifications etc. Regulatory Services: • Write, review, QC, hyperlink and compile all modules of IND, ANDA, NDA such as CMC section, module 2 clinical and non-clinical summaries etc. and execute the submission to FDA in eCTD format. The content of the modules would be reusable across products, countries and subsequent submissions without major re-work. • Submit subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was not made in eCTD format. • Write and compile pre-IND submission package for FDA review. • Write, review and compile 510(k) and pre-market application (PMA) for medical devices or drug-device combination products. • Drug product registration and establishment registration with FDA. • Serve as a liaison with regulatory agencies pertaining to assigned products/ teams. • Write/ review/ compile annual product report and other technical documentation. • Clinical trial assistance

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