🛡️ Get USFDA Certified with Shark Certification Pvt. Ltd. – Your Compliance Partner in Indore 🛡️ Looking to access the U.S. market? Ensure your products meet the highest international standards with USFDA certification support from Shark Certification Pvt. Ltd. Based in Indore, we provide expert regulatory consulting and certification services to help pharmaceutical, food, cosmetic, and medical device manufacturers navigate the complexities of FDA compliance. 🏛️ About the U.S. FDA The U.S. Food and Drug Administration (FDA) plays a pivotal role in protecting public health by regulating the safety and efficacy of: Pharmaceuticals and biologics Medical devices and diagnostic tools Food products and additives Cosmetics and colorants ✅ Why FDA Compliance Matters India is a global hub for pharmaceutical manufacturing, with many companies thriving in the U.S. generics market. However, staying FDA-compliant is critical to: Avoid import alerts or bans Secure product approvals (e.g., ANDA, NDA, 510(k), PMA) Maintain brand reputation Expand market access 🔍 Our USFDA Certification Support Services Include: CGMP Gap Assessments & Pre-Inspection Audits FDA Audit Readiness & Mock Inspections 21 CFR Part 11 & GAMP 5 Compliance Support Form 483 & Warning Letter Response Assistance PAI (Pre-Approval Inspection) Preparation Regulatory Dossier Support: IND, NDA, ANDA, IDE, 510(k), PMA Clinical & Data Integrity Audits (GCP, QMS, CSV) Process Validation & Quality by Design (QbD) Strategies Risk-Based Auditing & Quality System Design Training for FDA Audit Readiness 💼 Why Choose Shark Certification Pvt. Ltd.? Industry veterans with deep FDA expertise Proven track record across pharma, med devices & food sectors End-to-end support: from inspection prep to post-audit response Customized strategies to suit your regulatory and operational needs Commitment to precision, speed, and confidentiality Contact us.