1. Piramal Clinical Trial Services

2. Piramal Healthcare is a global pharmaceutical contract manufacturer whose key activities include Active Pharmaceutical Ingredient, Product Formulation and Packaging from development to full commercial scale. Who are Piramal? Piramal Clinical Trial Services adds to our clinical trial manufacturing capabilities.

5. UNITED KINGDOM 1. MORPETH API & Formulation Development & Manufacturing 2. GRANGEMOUTH Cytotoxic API Development & Manufacturing 3. BILLINGHAM Biocatalysis & Fermentation INDIA 1. MUMBAI R&D CENTRE API & Formulation Development 2. CHENNAI API Development & Manufacturing 3. HYDERABAD API Manufacturing 4. PITHAMPUR CTM Manufacturing 5. BANGALORE CTM Manufacturing CANADA 1. TORCAN API Development & Manufacturing Where are Piramal ?

6. Morpeth History 1969 Established by G.D.Searle 1986 Monsanto acquisition of G.D.Searle Searle operated as a division 2000 Searle/Pharmacia merged Solutia/Monsanto spun off 2003 Pharmacia acquired by Pfizer 2005 Pfizer to sell Morpeth 2006 Site acquired by NPIL 2008 Name change to Piramal Healthcare and re-branding

7. People and Environment Approximately 340 people employed Succession planning and talent management Learning resource centre The site has been continuously recognised as an “Investor In People” (the UK national standard for training & development) for over 16 years ISO 14001 awarded September 2005

8. Licenses MIA (IMP) 29595 Manufacturer's Authorisation Investigational Medicinal Products MS 29595 Manufacturer's "Specials" Licence MIA 29595 Manufacturer's/Importer's Licence Certificate of GMP Compliance of a Manufacturer Certificate No: UK ManA 29595/18244 - This covers human and veterinary products.

16. Our overriding aim is to offer customers and patients an unsurpassed quality of service and product. What makes Piramal different? Piramal take customer feedback very seriously. We want to get better at what we do, so it is important that we spend time talking to clients to find out where we can improve. We strive to offer continuity of relationships and agility for all customers, irrespective of project scope. Each customer is as important as the next.

17. Once we understand the scope we work hard to ensure that neither party ‘over commits’ and that we keep project activity focused on the real ‘value-add’ for the client. Customer service also means regular and rapid communications and a commitment to be transparent with information. We believe it is important to address issues early and honestly. Piramal follow a standard documented process which is mapped and procedural. What does ‘customer service’ mean?

18. Clinical Trial Service Process

19. A web based application used to track the status of manufacturing, distribution and drug returns Integrates with labelling software and uses barcodes to verify key stages of manufacture and distribution process Integrates with IVRS using HMTL & CSV formats to permit electronic transfer of data Provides be-spoke customer and site interface to view status of manufactured and distributed clinical trial kits How will I know what’s happening?

20. TrakPack ® – Reporting Examples Kit Compilation Status Quantity of kits completed, expected completion date Electronic Signatures Full audit trail of status changes to patient kit level IVRS order receipts Status of shipment order (received, processed, packaged, shipped, arrival) Expiry and re-test monitoring Returns Management Site & Deport stock reports Alerts on expiring stock based on client defined dates Patient kits returned, confirmed and full reconciliation Stock received, despatched and acknowledge to the patient kit level Report Data Reported