Peter Leung

Peter is a registered pharmacist in Hong Kong and Australia, as well as a certified Quality Professional with a Black Belt certification since 2007. He earned his MBA in 2019.

Peter has over 20 years of experience as a community pharmacist in Hong Kong. He also served as the QA Manager and Logistics Service Manager at Zuellig Pharma for five years before becoming the Director of PrudentLink Limited.

In his role as a Consultant Pharmacist at PrudentLink, Peter provides expert guidance on regulatory, advertising, marketing, and safety matters for a range of clients, from local businesses to multinational corporations. He specializes in developing regulatory strategies for pharmaceutical product registration and managing post-approval changes. Peter also has extensive experience in pre-launch preparations for health supplements and the registration of medical devices with the Medical Device Division of the Department of Health.

He advises pharmaceutical manufacturers and wholesalers on optimizing their marketing teams and logistics services. In 2018, Peter founded PrudentPharm, a platform for distributing a wide range of pharmaceutical products, medical devices, and health supplements to healthcare professionals in Hong Kong and Macau.

Since 2022, he has also served as an Independent Consultant for Parexel International (UK) Limited.

Professional Qualification & Technical Expertise

Registered Pharmacist

Community Pharmacy Operational Training

Wholesale Dealer Licence Application

Wholesale Quality Auditing and Compliance Upgrades

Food, Consumables, Medical Device and Pharmaceuticals Regulatory Affair

Liaison with Department of Health, in Hong Kong for regulatory affair

Product Registration and Post-approval Product Regulatory Affairs

Pharmaceutical Marketing and Logistic Development and Optimization

Lauren Lai

Lauren is a registered Pharmacist and a registered Authorized Person in Hong Kong. She has over 20 years of quality management experience in the pharmaceutical industry. She has been as a Quality Director, Authorized Person and Pharmacist-in-charge in pharmaceutical industries.

Lauren has conducted the PIC/s GMP and NMPA compliance audits in Hong Kong and Mainland China. Furthermore, she brought about the approval for a series of scale-ups and upgrades for a sterile biopharmaceutical facility to allow for the manufacture of an investigational medicinal product for clinical trials, as well as the commercial production of a sterile biopharmaceutical product. She is also specializes in regulatory affairs and wholesale distribution of pharmaceutical products.

Professional Qualification & Technical Expertise

Registered Authorized Person for Non-sterile and Sterile dosage forms

Registered Pharmacist

PIC/s GMP requirements for all dose forms

Gap analysis to PIC/s GMP standards

Quality Management Systems to ICH and PICs standards

GMP auditing and Compliance Upgrades

Industry Training in Risk, Compliance, PQS and GMPs.

Liaison with Department of Health in Hong Kong for developing or upgrading sites

Product Registration and Post-approval Product Regulatory Affairs

Wholesale Dealer Licence Application

Regulatory Affair Experience

Over 20 years of regulatory affair experience in Hong Kong, from product registration application to post-approval registration maintenance and deregistration, as well as change of manufacturer and certificate holder.

Currently, there are 3 companies’ product registrations – over 20 products under my management. In order to maintain product registration, CORP application will be carried out if there are any changes. All the CMC document, including product specification, Test method, manufacturing formula and process, product release document and labeling materials will be reviewed according to meet the latest legislations or upon request by clients.

Pharmaceutical Wholesale Dealing Experience

Licence Application	Assisted companies to obtain wholesale dealer licence. Preparation of application file and documents – including SOPs, Temperature Mapping for ambient or refrigerated storage.
Operation Readiness	Delivery system design, computerized record design, cold-chain set up and staff training.

Industry GMP and Regulation Experience

Site Readiness for Regulatory Audit	Over the last 20 years has prepared sites for NMPA and PICs inspection. Provides practical and achievable compliance improvement plans and supports site readiness for audits.
GMP Training & Mentorship for Key Personnel	As personal mentor for potential Authorized Persons and Quality Assurance Managers and other managerial positions in pharmaceutical companies. Organized group trainings in company in regards for GMP and QMS, and readiness for audits.
Plant Upgrade	Supported plant upgrade to PICs and NMPA Standards. Facilitated an upgrade of a veterinary production site to include human product manufacturing.
ATP Site Approval	Review the application submission file and facilitate the approval in principle of a new ATP site in Hong Kong.