ChemPharm is a consulting firm that provides services to the pharmaceutical, biotechnology, medical device, and cosmetics industries to help them achieve compliance with international quality standards. It has experts in areas like quality assurance, quality control, production, logistics, product development, and regulatory affairs. ChemPharm conducts activities like gap assessments, quality system implementations, audits, inspections preparations, and training. It aims to be a long-term partner to clients and help them go beyond just meeting requirements to gaining a competitive advantage.

1. CHEMPHARM
BEYOND COMPLIANCE
Chuan Yao
Principal Consultant
www.chempharm.asia

2. Presentation Content
• Introduce ChemPharm
• Our Expertise and Services
• International Standards
• Examples of ChemPharm’s Projects
• Trusted Customers

3. ChemPharm
ChemPharm is a professional full
service consulting firm that has
extensive practical expertise of
supporting Pharmaceutical,
Biotechnology, Medical Devices,
Traditional Chinese Medicine (TCM)
and Cosmetic industries. We stay
current with international regulatory
changes to maintain a truly upfront
global perspective. ChemPharm is
able to provide specialist expertise
across all areas including: QA, QC,
Production, Logistics, Product
Development and Regulatory Affairs.

4. Our Locations

5. Our Vision
To be a partner
To be ethical in everything we do
Sharing trust, strategy, information,
vision and benefits

6. Our Mission
 To provide expert services and support to the
Pharmaceutical, Biotechnology, Medical Devices,
Traditional Chinese Medicine (TCM) and Cosmetic
industries
 To be recognized as a major stakeholder in the
regional market

7. Critical Success Factors
• Quality people, processes and services
• Cohesive team approach
• Aligned strategies
• Performance measurability
• Clear understanding of what must be done

8. Competitive advantage
• Consulting group & associates
• International coverage
• All consultants industry experienced - broad range
• Consultants have direct FDA experience in
management
• Significant technical resource library
• Client loyalty and excellent industry reputation
• Combined training and consulting crossover

9. We Are Committed
We are committed to doing business in an ethical and socially
responsible manner.
We strive to develop long-term relationships with clients, based
on the highest levels of integrity, professionalism and trust.

10. Our Services
Integrated Business
Solutions

11. ChemPharm Services
Compliance Consulting and Risk Based Services
Gap analysis to all international regulatory standards
Quality Management Systems (QMS) development, implementation
and upgrades
GMP, GDP, GLP, and GCP compliance upgrades
GMP/QSR corporate policies and standard operating procedures
Technology transfer oversight
CAPAs and Deviations programs implementation and improvement
Independent third-party QSR, GMP, GCP, GLP, and ISO audit
Mock FDA audit
Supplier due diligence audit
GMP, GDP or GLP licensing support
Integration of risk management into corporate quality assurance
systems
Development of appropriate quality risk management tools
Gap analysis to identify and mitigate compliance risk
Implementation of risk mitigation activities
483, Warning Letter Response Strategy
Audit Nonconformance Response Strategy

12. ChemPharm Services
 Validation strategy and program development
 Validation master planning
 Validation documentation (plans, protocols, reports writing)
 Process validation
 Equipment qualification
 Facility and utility validation
 Software/21 CFR Part 11/computer system validation
 Conducting computer system GAMP compliance gap analysis
 Analytical method validation
 Cleaning validation
Validation Services

13. ChemPharm Services
 Product development strategy
 Dossier compilation as per ASEAN Common Technical Dossier (ACTD) Guidelines
 Dossier compilation in Common Technical Dossier (CTD) format
 Expert Report for Quality
 Regulatory submissions: United States, EU, China, Australia, New Zealand and
ASEAN countries
 Product Licence Maintenance
 Regulatory CMC Strategy and Dossier Preparation
 Drug Master File (DMF) compilation for open and closed parts
 510(k) Administrative Review and Submission
 FDA and notified-body liaison
 Authorized representation
Regulatory Affairs Services

14. ChemPharm Services
Training Services
 Customized training programs to meet clients'
requirements
 Training available in GMP/QSR/GDP/GLP(~ 10
modularised subjects)
 FDA inspection readiness
 Validation
 Risk Management
 How to avoid a warning letter
 Conduct of clinical trials

15.  At our site as your remote support team
 At your CMO's site as your "man in the plant"
 At your site as an integrated part of your current
team
Flexible Resourcing Solutions
ChemPharm Services

16. Our Highlights
• Extensive in-depth working knowledge and experience
• Wide understanding and knowledge of international regulations,
codes and standards
• We stay current with international updates and regulatory
standards
• Value all partnerships and are committed to doing business in an
ethical, sociably acceptable manner
• Strive to develop and maintain excellent relationships with clients
• Combined training and consulting crossover - integrated support

17. ChemPharm’s Business Statement
Beyond Compliance
We achieve this as ChemPharm consultants have
extensive in-depth working knowledge and
experience in International Regulations, Codes and
Standards, including the major GMP regulations,
codes and standards.

18. International Standards
• PIC/S Part 1, Part 2 and Annexes
• EU/UK EMEA, MHRA Eudralex Volume 4 (Orange Book)
• CFDA
• US FDA 21CFR Parts 210 and 211,
• US FDA 21 CFR Part 11 (Computers)
• US FDA 21 CFR Part 820 (Devices)
• WHO Guide to GMP 2007
• ASEAN Code of GMP
• ICH Q1, Q2, Q7, Q9, Q10
• ISO 17025, 14971, 13485,
• Industry Guidance Documents
(PDA, GAMP, ISPE)

19. • Global Pharma Corporations
• Biotechnology groups
• Companies setting up for big Pharma partnering
• Medical Device manufacturers- market transition
• National companies migrating product to FDA
• Computerised solutions and compliance
• Regulatory submissions
Examples of Projects

20. Examples of Projects
• Qualification of contractors and vendors
• Manufacturing process development and process validation
• Development of stability and Quality Control test programs
• Regulatory strategy and dossier preparation
• Responding to regulatory agencies
• Assisting National Companies with Regulatory submissions

21. Examples of Projects
• Quality Assurance over New Facilities
• New Facility Projects: Design, Procurement, Installation, Commissioning,
Validation (including Process Validation), QMS, Training
• Accreditation or registration of facilities to PIC/S, FDA, ISO 13485
• Validation including Computer Systems Validation
• Development of a compliant Quality Management System eg PIC/S, FDA,
EU, ISO 13485
• Gap Analysis, remediation planning and implementation for QMS,
Computer Systems, Validation, Product Development
• Training of staff
• Project Planning
• Risk Assessments

22. ChemPharm Types of Clients
• Multinational Pharmaceutical and Medical Device Corporations
• National Pharmaceutical Companies
• National Medical Device Manufacturers
• Medical Device, Pharmaceutical and Biological Start-up Companies
(GLP …. Phase I/II)
• Contract Manufacturers in Pharmaceutical, Medical Device and
Biological Industries
• Chinese Herbal Medicine / Complimentary Medicine Companies
• Suppliers to these regulated industries
• Clinical Trial Facilities

23. Examples of some ChemPharm
Clients