Supporting U.S. Pharma with Global Regulatory Expertise
USA's Leading GMP Audit & Compliance Consulting Company
For entering the U.S. pharma market, there are some important things to do, including strict adherence to the current Good Manufacturing Practices (cGMP). KNORS Pharma, one of the leading pharma audit companies, provides GMP audit consulting and inspection preparedness to pharmaceutical, API, CDMO, and biotech companies to meet regulatory compliance. Our team of consultants helps in the completion of tasks related to FDA, WHO-GMP audits, GAP assessments, CAPA, improvement of quality systems, and regulatory documentation.
KNORS Pharma Solutions LLP offers comprehensive services for pre-inspection preparedness and post-audit remediation to meet the objectives of achieving regulatory compliance with ease and efficiency.
Services We Offer
The GMP auditors certified by KNORS Pharma Solutions LLP conduct independent third-party audits for pharmaceutical manufacturers, API facilities, packaging suppliers, excipient manufacturers, and testing laboratories. As experienced third party GMP auditors, our objective is to identify any compliance risk, improve quality systems, and make the facility ready for FDA & international regulatory inspections.
The GMP auditors certified by KNORS Pharma Solutions LLP conduct independent third-party audits for pharmaceutical manufacturers, API facilities, packaging suppliers, excipient manufacturers, and testing laboratories. As experienced third party GMP auditors, our objective is to identify any compliance risk, improve quality systems, and make the facility ready for FDA & international regulatory inspections.
We offer customized GMP training programs for FDA inspection readiness, data integrity, root cause analysis, OOS investigations, CAPA management, quality risk management, and internal auditor certification. This helps you in developing compliance-focused teams.
KNORS Pharma Solutions LLP prepares and manages DMF, ASMF, APIMF, ANDA, eCTD, and other regulatory submissions. As established regulatory affairs consultants in India, we offer deficiency response, technical documentation, and product registration assistance for the U.S FDA and other international regulatory authorities.
KNORS Pharma Solutions LLP identifies and qualifies the reliable manufacturer for APIs, intermediates, excipients, and finished dosage forms. Our technical and regulatory assessments assure the security of sourcing the products in the regulated markets like the U.S. and Europe.
We offer GMP compliance audits, supplier audits, technical documentation reviews, quality system assessments, and regulatory consulting. Our specialized pharma GMP audit consulting services aim to minimize the compliance risks and improve the operational effectiveness, along with inspection readiness.
A comprehensive GAP analysis conducted by us will compare the operations with the FDA and international GMP requirements. We will identify the deficiencies and help in prioritizing corrective actions, along with providing a compliance roadmap for faster regulatory approvals and inspection readiness.
KNORS Pharma Solutions LLP performs the pharmaceutical due diligence in manufacturing operations, quality systems, regulatory compliance, technical capabilities, intellectual property, and business risks. It makes it possible to make confident investments, acquisitions, supplier selection, and strategic partnerships.
Why KNORS Pharma Solutions LLP?
FDA-Focused GMP Auditing Experts
Our experienced auditors conduct the comprehensive GMP assessment in accordance with the expectations of the U.S. FDA. As trusted third party GMP auditors, we will help in finding out hidden compliance risks and assessing the manufacturing process. We provide practical recommendations for inspection readiness and long-term regulatory compliance.
FDA Inspection Preparedness
We use the GAP assessment methodology and compliance tools based on risk to prepare the pharmaceutical facilities for FDA inspections. We will help in designing the CAPA plans, which will solve the issues quickly and enhance quality management systems.
Complete U.S. Regulatory Affairs Services
From the preparation of DMF and ANDA to eCTD publishing and submission management, we provide end-to-end services for pharmaceutical companies. This will help to obtain approvals in the highly regulated U.S. market.
Industry-Leading GMP Training Programs
KNORS Pharma Solutions LLP offers GMP training programs based on instructor-led training. Our courses include the latest updates about FDA expectations, data integrity, CAPA, OOS investigations, quality risk management, and more.
Trusted Supplier Qualification Globally
We evaluate the pharmaceutical manufacturers based on technical, quality, and regulatory assessments. Our supplier qualification process helps the U.S. customers to have reliable global supply chains.