REGULATORY SERVICE SUPPORT

We are helping our client with product classification and facilitating their product to launch.

Our Services include:

Product Classification

Facilitate interactions with the Drug Office, Department of Health on regulatory issues and respond to their questions.

Regulatory consulting on advertising and marketing

Post-Approval registration services

Advice on Labelling and advertisement – to comply with :

      - Food Safety Ordinance (FSO)

      - Undesirable Advertisement Ordinance(UMAO)

      - Trade Description Ordinance (TDO)

      - Food and Drugs (Composition and Labelling) Regulations (Cap132W)

PRODUCT REGISTRATION

We are assisting our clients in preparing registration dossier for Hong Kong registration submission.

Our Services include:

Acting as your independent regulatory representative for registration of imported Pharmaceutical Products and Medical Devices in HK

Evaluation of Documentation and supervision of related tasks

Pharmaceutical Products and Medical Devices regulatory consulting

Marketing Authorization holder maintenance, renewal and transfer

PRODUCT IMPORT AND EXPORT

We are a licensed company for import and export of pharmaceutical products for marketing or clinical trial.

Our Services include:

Acting as your independent representative for importation of Pharmaceutical Products into HK

Facilitate interactions with the Drug Office, Department of Health on importation of product for clinical trial or product in transit.

TRADE AND DISTRIBUTION

We provide an extensive coverage to various sales channels and outlets, as well as regular deliveries.

Our Services include:

Product marketing and distribution

Assisting client to become licensed Pharmaceutical Dealer

Pharmaceutical or Food Importer or Exporter

Wholesaling / Retailing of Pharmaceutical product

CLINICAL TRIAL MANAGEMENT

Our Services include:

Acting as your independent representative for the application for the Certificate for Clinical Trial/Medicinal Test

Clinical Trial Storage

Base on product nature & requirements on storage, pick, pack

Check process to tailor made SOP for individual.

Logistic Arrangement

Import & Export, transportation requirements for HK market.

PHARMACEUTICAL BUSINESS SETUP

We have been assisting our clients to set up their pharmaceutical business in Hong Kong.

Our Services include:

Pharmaceutical or Food Importer or Exporter

Wholesaling / Retailing of Pharmaceutical product

Authorized Seller of Poisons (ASP)

Listed Seller of Poisons (LSP)

TRAINING FOR MANUFACTURERS AND WHOLESALE DEALERS

Our Services include:

Mock Audit / Inspection

Training on Quality Management System (QMS)

Comprehensive training related to QMS (Including ISO 9001, GDP, cGMP)

Set up or fine tuning their QMS

Know-how on how to write, review and implement current SOP effectively.

Preparing your internal, external and third party audit.

REGULATORY SERVICE SUPPORT

We are helping our client with product classification and facilitating their product to launch.

Our Services include:

PIC/s GMP requirements for all dose forms, including Sterile

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