National Service Hotline:
One-stop chemical compliance services, providing chemical compliance consulting services
GMP system construction
GMP Compliance and Certification
Provide a package of services from system establishment, improvement, audit, simulation inspection to official certification inspection.
Includes:
(1) China GMP certification
| GMP certification of domestic enterprises | NMPA on-site inspection of overseas enterprises |
(2) International GMP certification
| FDA, EU, Australia, WHO, PIC/S GMP certification | GMP non-conformance/483/warning letter rectification |
(3)GMP professional translation
| GMP Inspection Chinese-English Interpretation/Translation | GMP Inspection Korea-China, Japan-China Interpreter/Translator |
(4)GMP Engineering
| New/remodeled plant (workshop) planning, design and GMP compliance consultation | |
(5) R & D laboratory system regulations comply
| R & D system establishment/defect rectification guidance/audit, etc. |
Validation Test Consulting
(1) Equipment/instrument validation service
(2) Process/method/system validation services
(3) Computerized system verification services
Domestic registration
(1) Imported/domestic drug registration
| (2) Domestic drug research and development guidance services. | (3) Imported/domestic health food registration | (4) Registration of imported/domestic cosmetics |
Registration of Imported/Domestic Preparations
| Imported/Domestic Cosmetics Filing/Administrative License Application | ||
Imported/Domestic API Registration
| Registration of new raw materials for cosmetics | ||
Registration of Imported/Domestic Pharmaceutical Excipients
| |||
Registration of imported/domestic pharmaceutical packaging materials
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International Registration
(1) Drugs
EU Drug Registration (MA Application)
|
Drug Registration in Australia |
US FDA Factory Registration and NDC Application |
EU CEP/COS Application
|
WHO supplier pre-certification
|
SMF File Production
|
EU Register of Traditional Herbs
|
American DMF Document Production and Archiving
|
eCTD format conversion
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(2) Health food
1. U.S. Dietary Supplement Certification and New Intake (NDI) Notice
2. American food additive certification
3. EU food supplement/additive certification
4. EU New Food (Novel Food) and ingredient certification
Pharmaceutical Marketing Certificate Holder (MAH) Custody Services
Consultant on Pharmaceutical Affairs
Enterprise perennial pharmaceutical regulations consultant
Technology transfer of pharmaceutical products
Local registrant system and regulations push, always keep the policy information ahead.
Registrant model planning, binding R & D-manufacturing two systems
Trustee system evaluation template to help registrants find suitable manufacturers
The registrant's quality system and risk system provide reliable support for product listing and registration.
GMP simulation inspection, for registrants to successfully pass the verification plus insurance
Supplier recommend, from fiduciary manufacturer to product testing, raw material selection
GMP/Production Quality System Services
Construction and implementation of GMP system in pharmaceutical manufacturing enterprises: risk management, deviation and change control, data reliability, OOS/OOT investigation, product quality review, etc.
Construction and Implementation of GMP ISO13485 System for Medical Device Manufacturers
Construction and Implementation of GLP GMP System in Pharmaceutical R & D Enterprises
Construction and implementation of ISO9000 BRC GMP system for dietary supplement manufacturers
Design review of purification plant
GMP Project Design Review
GMP Project Management and Service
GMP Plant Audit and Audit Project Management
Quality Audit and Factory Due Diligence
Mock Audit (Mock Audit)
GMP Status Assessment for FDA/EDQM
Provide third-party registration review/GMP simulation on-site inspection, quality audit
Provide third-party due diligence for pharmaceutical plant M & A or MAH purposes
Assess the factory's manufacturing level, production capacity, production operation management capacity, and product transfer capacity.
Registrant System Construction/MAH
OUR SERVICES
One. GMP Compliance and Certification
2. pharmaceutical excipients, pharmaceutical packaging materials, API registration services
Three. Pharmaceutical Marketing Certificate Holder (MAH) Custody Services
4. GMP/production quality system service
V. Design Review of Purification Plant
VI. Quality Audit and Factory Due Diligence
National Service Hotline:
Beijing Headquarters: D10, Floor 4, Block A, Borui Building, No.26, Dongsanhuan North Road, Chaoyang District, Beijing, China
Tel: 86-010-6471 0683
Shanghai: Room D308, Zhongyi International Building, Puxing Highway 800, Minhang District, Shanghai
Tel: 86-021-3478 3993
Guangzhou: Room 201, Xinying Technology Park, No. 313 Jinxin Avenue, Panyu District, Guangzhou
Tel:400 660 1329
E-mail：nar@china-reach.net
Copyright: New Anrun (Beijing) Consulting Co., Ltd.
