EXPERIENCE. EXCELLENCE.
REGULATORY AFFAIRS
Our Regulatory Affairs consulting group is comprised of former senior-level FDA managers, FDA reviewers, and industry experts. Our goal is simple; provide simple, workable solutions for client’s regulatory problems or issues at the highest levels of efficiency and excellence.
Services and features include advising on a full range of regulatory compliance and scientific issues related to generics (including complex generics) and new drugs, as well as prepare and/or provide assistance in the preparation and electronic submission of all types of FDA regulatory documents, including drug applications, e.g., ANDAs, NDAs (5050(b)(2) and 505 (b)(1)), DMFs (Type II, III, IV), and other FDA regulatory forms.
GLOBAL SERVICES & SOLUTIONS
COMPREHENSIVE CAPABILITIES. PROVEN EXPERIENCE.
Organizations around the world trust the people and services of APAC FDA Consulting to responsively guide and connect them with the best insights, information, and analysis to overcome their challenges and achieve optimum results.
Compliance
data integrity
analytical services
biomonitoring support
strategic planning
Founder & President
Meet Kelvin Hooi
Responsible for performing, managing and overview of internal and external audit program to ensure that drug products (Biologics/Small Molecules/Medical Devices) are manufactured within compliance of international GMP regulations and guidelines.
The scope of pharmaceutical operations which are audited include Active Pharmaceutical Ingredient (API) / Drug Substance (DS), Aseptic Fill/Finish, QC Testing, Packaging/Labeling and Warehouse & Distribution in support of global manufacturing and supply chain for clinical and commercial drug products.
Area covered in GMP, FDA, NMPA, Health Science Authority, TGA (Australia), Inspection Readiness, Combination Products, Quality Experts and Contract Manufacturing / CDMO.
Conduct audits at operating units across all sectors (Pharma, Medical Device & Diagnostics) to determine ability of site to meet global regulatory compliance requirements.
Determine & document site inspection readiness, facility operating conditions and adherence to enterprise policies & SOPs and regulatory requirements. Identify and communicate compliance status and common issues/trends via an independent audit assessment process.
Perform GXP Quality Management and Audit activities within the pharmaceutical, biotech, and medical device industries. (Eudralex Vol. 4 GMP Guidelines) Audits include: Quality Systems Audits, Supplier and Vendor Quality Audits, Vendor Management, Remote Vendor Qualifications and Assessments, and Computer Systems Validation Audits, Analytical and Microbiological Laboratory, Stability, Contract Manufacturing Organizations (CMO), API Manufacturers, and 21 CFR Part 11 Compliance Audits.
Internal Process Audits Experience: Device Design, Supplier Quality, HACCP, Risk, Customer Care (CRM), Field Service, CAPA, Compliance, Clinical, Regulatory, Change Control, Complaints, Production, Quality Systems, Environmental Systems.
External Regulatory, Notified Body, Sponsor and Customer Audit Hosting and Liaison. Regulatory Inspection Gap Assessment.
21 CFR Part 11 Electronic Records, Electronic Signatures audits focused on Distributed Control Systems for large scale bio-pharmaceutical manufacturing, Primary Logic Controllers (PLC’s) and Laboratory automated systems such as Empower for HPLC systems. Trackwise, Veeva, Sharepoint, Agile, MasterControl, and other Quality Management Electronic Systems (QMS).
Mr. Kelvin Hooi
Third Party Logistics: Performed initial qualification audits at global suppliers, drug depots, couriers and warehouse suppliers per WHO, EU, EC, ICH, FDA Good Distribution Practices. Set-up and completed global audit plans for Logistics suppliers.
GCP audits for CRO’s and their associated clinic pharmacies for both compounding and non-compounding pharmacies. (Phase I and II Clinics) 503A, 503B of the FD&C Act. Pharmacy Binder reviews for Clinical Trials.
Conduct audits to evaluate compliance to ISO 13485; ISO 14001; ISO 9001; ISO 14971; IEC 62366; 21CFR 210, 211, 11, 312, 820, 803, 812; ICH Q8, Q9, Q10; GCP, USP, SQF, GDP, GLP, Canadian MDR, EMA, MHRA Medical Device Directive (MDD), PMDA.