Complywell Solutions

ComplyWell Solutions is a premier consulting firm serving to build, assess and improve regulatory compliance in the biopharmaceutical industry. Based on the experience of conducting more than 350+ GXP audits globally (including >100 investigator site audits) in the pharmaceutical and CRO industry, we provide the following services globally : •Quality Management System Development •GXP Auditing -GMP – Drug development laboratory, API or formulation manufacturing facility, Drug depot, etc-GCP – Investigator sites, DM, Pharmacovigilance, Global processes, CRO / FSP, Phase I & BE, etc-GLP -GXP – Vendor qualification, Local country affiliates, Regulatory affairs, Off-site archive, Central lab • Inspection / Due-Diligence – Preparation, training and hosting •Regulatory Affairs •Boutique Services -Remote Compliance Monitoring -GXP Compliance Lead Be it the selection and audit of your GXP vendors, review of the operational and quality agreements, on-going compliance or management of the regulatory inspections, ComplyWell Solutions can monitor the GXP compliance of the entire spectrum of activities on your development program (e.g. biosimilar development) and can help you to remain inspection-ready. ComplyWell Solutions can perform batch compliance review almost in real time due to its proximity to the pharmaceutical manufacturing hub in India. With the increased scrutiny of the relationship between the CMO and the marketing authorization holders by the regulatory authorities, it will increase your confidence in the product you use for clinical studies or for distribution in the market and alleviate the chances of an investigation, product hold or recall post-distribution. Aim to be Your Partner of Choice for Quality Assurance and Regulatory Affairs.