Company presentation

1. We know the API business inside out
Chartwell Actives
Our Value
JG/MF
01.12.2016
00Z00PP01002_1_NOV16

2. Our Value
Index
2
Overview
Areas of Expertise
Scope of Work

3. Chartwell Actives LLC, a USA company with a divison located in
Europe (Portugal)
Overview
We know the API business inside out3
We have a team of industry experts with
decades of experience in GMP applied to
API Manufacturing:
Research and Development, Engineering,
Quality Control, Quality Assurance and
Regulatory Affairs in a US FDA and EU
EDQM environment.
Downstream

4. Bring your production facilities ready for a successful FDA / EMEA inspection.
Cover all regulatory affairs issues related both with the API and with FDF
assisting you in filing DMFs with the FDA and CEP filings with EDQM.
Assist you with all the process optimization/scale up/industrialization that
might be needed in terms of the API production.
We know the API business inside out4
Overview
Assist you in finding the right IV CMO in the US and in developing the
necessary ANDAs.
Assist you in launching your products in the market.

5. 5
Overview
Our Mission
We know the API business inside out
Develop and
produce APIs and
other specialty
ingredients through
effective biotech and
chemical synthesis
processes, in full
compliance with
cGMP
Be your western
partner of choice
in getting your
product to market
Helping you optimize your
current production processes
and reach the next level of
regulatory compliance

6. Index
6
Presentation
Areas of Expertise
Scope of Work
Our Value

7. Thinking out of the
box
Translating
science into value
Opening doors to your
product
Effective cGMP
Compliance
Improved productivity
BUSINESS
DEVELOPMENT
RESEARCH &
DEVELOPMENT
ENGINEERING
PROCESSES
QUALITY
REGULATOR
Y AFFAIRS
Help bring your
products to the
market
Areas of Expertise
We know the API business inside out7
Technology that
fits your needs

8. Helping you in changing the “status quo” of your business
 Planning
 Helping you managing your Product Portfolio for profit;
 Adding for growth
 Tech Transfering IP in, to match your current plant capabilities;
 Helping you enter high value, sophisticated markets like the US;
 Subtracting for profit
 Tech Transfering IP out, to help you monetize on your dormant knowledge;
 Business process improvement
 Helping you improve/optimize your production processes for better yields and productivity identifying
and breaking process constraints;
 Helping you in structuring your deals for maximum profit;
 Competitive awareness and advantage
 Helping you predicting the actions of competitors and planning suitable counter strategies to achieve
competitive advantage.
Areas of Expertise
We know the API business inside out8

9. Areas of Expertise
 Process improvement and Optimization towards Process efficiency and cost
reduction;
 Process Development and Scale-up to Commercial scale;
 Creation of “in-silico” IP;
 Ability to work in multidisciplinary, multi-project environment.
We know the API business inside out9

10. Areas of Expertise
 Project design, installation, commissioning/ qualification and start-up of API
facilities in compliance with GMP, GEP and GAMP;
 Knowledge and expertise to manage and maintain equipment and facilities under
strict overall equipment eficiency standards.
We know the API business inside out10

11. Areas of Expertise
We know the API business inside out11
 Strong expertise in API manufacturing through
 Fermentation and Downstream
 Chemical Synthesis
 Shop-floor experience/ troubleshooting
 Implementation of methodologies for productivity improvement
 Goals
 Increasing process yields
 Reducing production cycles
 Minimizing solvent use and waste generation
 Optimizing operations
 Methodologies
 Lean Six Sigma
 Kaizen
 5S
 Statistical Process Control

12. Areas of Expertise
 Implementation and maintenance of cGMP Quality Systems (ICH, FDA and European
regulations and guidelines);
 Experience in sucessful FDA/ European Authorities Inspections and customer audits;
 Auditing API companies world-wide.
We know the API business inside out12

13. Areas of Expertise
 Submission of Regulatory Registrations
 DMF's in FDA (USA) and Health Canada;
 CEP (CoS) (EDQM)
 ASMF’s in European National Agencies (under National Authorization,
Decentralized (DCP) or Mutual Recognition Procedures (MRP))
 Schedules in India;
 Other countries: Russia, South Africa, Latin America;
 Management of Regulatory Registrations
We know the API business inside out13

14. Index
14
Presentation
Areas of Expertise
Scope of Work
Our Value

15. o Gap Analysis (on-site audit)
o Review of Quality and
Regulatory Documents
o GMP audits on behalf of
client
o Due Dilligence
o Follow-up
o Workshops
o Lectures
o Support on execution
o Execution itself (in any of
our areas of expertise)
ASSESSMENT TRAINING EXECUTION
Scope of Work
15 We know the API business inside out

16. Business
Development
Need for an API (generic)
A process in need of
development and/or
optimization
To have a process
To find business partners
(API or FDF)
Get it ready for scale-up
o Patent Busting/ alternative chemical
pathways devising/ technical legal
support
o Dossier busting (inactive DMFs, etc)
o Use our network to find the right
partner for your business
o Custom Synthesis
o Contract Research
o Process Optimization (DoE)
o CMA, CPPs and QCA analysis
o Impurity identification, isolation,
qualification and synthesis
o Crystallization/ Polymorphism studies
(DoE)
o Genotoxic impurities assessment
o Analytical methods development
o Cleaning methods development + swab
recovery studies
o Forced Degradation Studies
o Quality Risk Assessment
o Environment & Safety Risk Assessment
o Proof of concept
In near future in our own Lab facilities
Scope of Work
STAGE IF YOU HAVE... AND YOU WANT...
HERE’S WHAT
WE CAN DO FOR YOU
16 We know the API business inside out

17. Scale-up
Registration
Lab scale process
Validated process
Pilot/ Industrial scale
process
Go to market
o Selection of CMO partner (GMP
compliance/ Technology assessment)
o Preparation of Technical Package for
Technology Transfer
o Raw-material supplier selection and
qualification
o Project Management (Tasks, Time and
Cost)
o Communication between client and
CMO partners
o Troubleshooting/ problem solving
In future in our own Pilot plant facilities
o Working as a team with CMO (roles to be
defined case by case):
o Equipment Qualification
o Analytical Methods Validation
o Cleaning Validation
o Manufacturing Process Validation
o Writing (or reviewing) DMF/ eCTD
documents
o Submission of registration dossiers
o Answer potential defficiency letters
Scope of Work
STAGE IF YOU HAVE... AND YOU WANT...
HERE’S WHAT
WE CAN DO FOR YOU
17 We know the API business inside out
Validation Industrial process Validated process

18. Improvement
Whenever
An API production facility
a problem
Improve cGMP compliance
status
or
To get ready for authority
inspection (FDA/ EU
agencies)
a solution
o Phase I (to know what needs to be done):
o Gap Analysis on-site audit (referential:
ICH Q7)
o Phase II (for implementation of the
improvement actions previously
identified):
o Training (teach you how to do it)
o Execution of improvement actions:
o Assistance on execution (we do it
together)
o Execution (we do it for you)
You decide.
o Technology assessment for Yield
improvement
o Introduction to Lean Six Sigma
Methodology
o Implementation of 5S Methodology
o Risk-based methodology for
Maintenance Programs
o Energy Efficiency Assessment
o Provided we have the know-how, we will
use it to design a service that specifically
answers your needs
Scope of Work
STAGE IF YOU HAVE... AND YOU WANT...
HERE’S WHAT
WE CAN DO FOR YOU
18 We know the API business inside out
Improve productivity

19. We know the API business inside out
Thank you!
JG/MF
01.12.2016