L I F E S C I E N C E S

GMP LABORATORYTESTING SERVICES

Chemistry | MicrobiologyPhysical Testing | Stability Storage

PHARMACEUTICALS

MEDICAL DEVICES

DRUG - DEVICE COMBINATION PRODUCTS

I M P R O V I N G O U R H E A L T H

Company Profile_LifeSciences_AUGUST2014_Rev4

Minnesota Life Sciences1311 Helmo Avenue NoOakdale, MN 55128 P: 651.738.2728 F: 651.714.9360www.pacelabs.com

Puerto Rice Life SciencesP.O Box 325Calle B & Calle CEl Retiro Industrial ZoneSan German, PR 00683 P: 787.892.2650F: 787.892.1054

At Pace, we strive to deliver what our customers value most to help them succeed —integrity, reliability, technical expertise and market strength

of a highly respected industry veteran.

For the past 35 years, Pace Analytical has operated one of the largest full-service commercial contract laboratory networks in the nation, providing support for thousands of industry, consulting, and regulatory professionals in many industries. Our investments in laboratory facilities, technology, training and staffing, along with our extensive experience in laboratory testing, demonstrate our commitment to providing comprehensive, consistent and reliable analytical services. Pace Analytical has more than 1,500 employees in 36 locations nationwide.

For the past eight years, Pace Analytical Life Sciences, a division of Pace Analytical Services, has supported the pharmaceutical and medical device industries. Life Sciences operates two cGMP compliant facilities: one located in Oakdale, Minnesota, and the other located in San German, Puerto Rico. Our Oakdale, MN facility is 60,000 square-feet, ISO/IEC 17025:2005 accredited and houses over 110 employees. Our laboratory in San German, Puerto Rico, is 12,000 square-feet and houses more than 70 employees.

Analytical Chemistry Services • Method Development and Validation• Raw Material/Compendia Testing (USP, EP, JP, BP,

FCC, ACS)• Finished-Product Release Testing• Extractable/Leachable Testing• HPLC and GC Assays and Impurity Profiles• Dissolution/Elution/Drug Release Profiles• Elemental Impurities (ICP-OES, ICP-MS, AA, GFAA,

CVAA)• Mass Spectroscopy (LC-MS, LC-MS/MS, GC-MS,

ICP-MS)• Cleaning Verification/Validation• Residual Solvents Analysis• Aerosol Testing Services (ACI/NGI)

Microbiology Services• Method Development and Validation• Raw Material/Compendia Testing (USP, EP, JP, BP,

FCC, ACS)• Finished-Product Release Testing• Microbial Bioburden • Sterility Testing/Biological Indicators• Bacterial Endotoxins• Particulate Matter USP <788>• Microbial Limits Testing• Antimicrobial Effectiveness Testing• Disinfectant Efficacy Studies• Environmental Monitoring Services

Supporting Medical Innovation Worldwide: Full-service contract analytical chemistry and microbiology testing services

Every day our employees work together to provide quality testing services that ensure the safety and efficacy of treatments and therapies created by local and global manufacturers of drugs and medical devices. We share a common goal of providing solutions that bring real value to people, healthcare professionals and health businesses around the world. Our business model and our dedication to ensuring reliable and effective healthcare solutions are indelibly linked. Driven by our commitment to improve our health, we deliver products and services that offer hope—and a better, safer and healthier life for everyone.

Clients We ServePace Analytical enjoys close working relationships with many prominent pharmaceutical and medical device manufacturing firms, and our laboratories are recognized as key suppliers in partnerships with many local and global companies.

We are one of the top CMC laboratories in the United States, routinely working with 8 of the top-10 global pharmaceutical companies, 12 of the top-14 global medical device companies and many small/medium and virtual businesses nationwide. These partnerships enable us to work closely with our clients to help them address emerging regulatory and quality issues and any unique testing requirements.

Our investment in state-of-the-art facilities and highly trained personnel emphasizes our commitment to deliver positive customer experiences across all channels of our business. We are dedicated to providing not only the best in analytical and microbiology testing services, but also the most reliable—and we are well-equipped to handle almost any project regardless of scope or complexity.

Pace Analytical Life Sciences operates two FDA-registered, DEA-registered (Class I – V), cGMP-compliant facilities: one located in Oakdale, MN and the other located in San German, PR. Our Oakdale, MN facility is lSO/IEC 17025:2005 accredited. Both facilities have long-established histories of very successful audit outcomes from both regulatory agency and partner-client auditors.

PacePort: Online Data Management

Our Laboratories and Our ServicesOur two FDA-registered, GMP-compliant laboratories offer clients access to expertise in testing various devices and dosage forms including: implantable devices, reusable devices, transdermal delivery systems, aerosols, creams/ointments, oral tablets and capsules, and device-drug combination products.

Stability Storage• ICH Storage Conditions ~ 15,000 cu. ft. Storage• -80°C, Reach-In• -20°C, Reach-In• 5°C, Walk-In• 25°C/60% RH, Walk-In• 30°C/65% RH, Walk-In• 40°C/75% RH, Walk-In• 37°C, 45°C, and 50°C Accelerated Aging• Custom Conditions and Reach-In Chambers• Photo-Stability, ICH Q1b (Option 2)• Continuous Monitoring and Emergency

Power Systems

Physical Testing• Temperature and Humidity Controlled Lab• Instron Testing

– Tensile and Elongation – Peel Force, Peel to Steel – Release Liner Adhesion

• Container Closure Integrity/Ingress Testing• Probe-Tack/Loop-Tack Testing• Shear Testing• Penetrometer Testing (gels)• Burst/Creep Package Integrity • Hardness Testing

Complete Laboratory Programs• Fee-for-Service Testing Programs• On-site / Off-site Dedicated Staff• Laboratory Capital Equipment• Full-Time Equivalent (FTE) Programs

PacePort is our industry-leading, web-based application that provides instant access to your laboratory information—anywhere, anytime! No software downloads are needed, PacePort is a secure web-based portal that requires only a web browser and PDF Reader.

PacePort provides complete data packages for every project within hours of the final signatures from our Quality Assurance review group. Every page is in high-resolution and in color – easy to read, easy to understand and completely audit-ready. Use PacePort to access every final report and the protocol, procedure, method and data package that supports it.

Why Partner With Pace Analytical? Strategic partnering with Pace Analytical is a key accelerator to getting your products to market on time and on budget. Our ability to excel in combining superior performance on the essential laboratory service elements results in the best customer experience in our industry.

Client-friendly Data Delivery and Management: PacePort, our industry-leading online web portal, provides instant access to audit-ready final reports, protocols, procedures, methods and data packages. PacePort is a custom and proprietary tool that represents our continual efforts to refine our data-delivery systems for the convenience of our clients.

Culture of Service: For 35 years Pace Analytical has worked to provide the best service and has developed a reputation for reliable laboratory service delivery. Pace strives to establish partnerships with each client to better understand specific needs. By establishing long-term relationships, the best interests of both the client and Pace are met.

Integrity: Pace Analytical recognizes that our product is information. Our mission, purpose and values set high standards for all employees and define the open and honest culture under which Pace operates. Our core values ensure the integrity of all data generated by Pace.

Flexible Response to Demand: Pace is committed to providing services to all clients, large or small. Service models include fee-for-services, dedicated resource programs, full-time equivalent (FTE) model on-site at PLS, and/or FTE programs at the client site, which allow for economical options to meet business demands.

Quality: Both of our laboratories have long histories of successful regulatory agency, client and third-party audits. All data goes through 100% independent review by Quality Assurance technical data review specialists before it is released and reported.

Analytical Chemistry Services • Method Development and Validation• Raw Material/Compendia Testing (USP, EP, JP, BP,

FCC, ACS)• Finished-Product Release Testing• Extractable/Leachable Testing• HPLC and GC Assays and Impurity Profiles• Dissolution/Elution/Drug Release Profiles• Elemental Impurities (ICP-OES, ICP-MS, AA, GFAA,

CVAA)• Mass Spectroscopy (LC-MS, LC-MS/MS, GC-MS,

ICP-MS)• Cleaning Verification/Validation• Residual Solvents Analysis• Aerosol Testing Services (ACI/NGI)

Microbiology Services• Method Development and Validation• Raw Material/Compendia Testing (USP, EP, JP, BP,

FCC, ACS)• Finished-Product Release Testing• Microbial Bioburden • Sterility Testing/Biological Indicators• Bacterial Endotoxins• Particulate Matter USP <788>• Microbial Limits Testing• Antimicrobial Effectiveness Testing• Disinfectant Efficacy Studies• Environmental Monitoring Services

Supporting Medical Innovation Worldwide: Full-service contract analytical chemistry and microbiology testing services

Every day our employees work together to provide quality testing services that ensure the safety and efficacy of treatments and therapies created by local and global manufacturers of drugs and medical devices. We share a common goal of providing solutions that bring real value to people, healthcare professionals and health businesses around the world. Our business model and our dedication to ensuring reliable and effective healthcare solutions are indelibly linked. Driven by our commitment to improve our health, we deliver products and services that offer hope—and a better, safer and healthier life for everyone.

Clients We ServePace Analytical enjoys close working relationships with many prominent pharmaceutical and medical device manufacturing firms, and our laboratories are recognized as key suppliers in partnerships with many local and global companies.

We are one of the top CMC laboratories in the United States, routinely working with 8 of the top-10 global pharmaceutical companies, 12 of the top-14 global medical device companies and many small/medium and virtual businesses nationwide. These partnerships enable us to work closely with our clients to help them address emerging regulatory and quality issues and any unique testing requirements.

Our investment in state-of-the-art facilities and highly trained personnel emphasizes our commitment to deliver positive customer experiences across all channels of our business. We are dedicated to providing not only the best in analytical and microbiology testing services, but also the most reliable—and we are well-equipped to handle almost any project regardless of scope or complexity.

Pace Analytical Life Sciences operates two FDA-registered, DEA-registered (Class I – V), cGMP-compliant facilities: one located in Oakdale, MN and the other located in San German, PR. Our Oakdale, MN facility is lSO/IEC 17025:2005 accredited. Both facilities have long-established histories of very successful audit outcomes from both regulatory agency and partner-client auditors.

PacePort: Online Data Management

Our Laboratories and Our ServicesOur two FDA-registered, GMP-compliant laboratories offer clients access to expertise in testing various devices and dosage forms including: implantable devices, reusable devices, transdermal delivery systems, aerosols, creams/ointments, oral tablets and capsules, and device-drug combination products.

Stability Storage• ICH Storage Conditions ~ 15,000 cu. ft. Storage• -80°C, Reach-In• -20°C, Reach-In• 5°C, Walk-In• 25°C/60% RH, Walk-In• 30°C/65% RH, Walk-In• 40°C/75% RH, Walk-In• 37°C, 45°C, and 50°C Accelerated Aging• Custom Conditions and Reach-In Chambers• Photo-Stability, ICH Q1b (Option 2)• Continuous Monitoring and Emergency

Power Systems

Physical Testing• Temperature and Humidity Controlled Lab• Instron Testing

– Tensile and Elongation – Peel Force, Peel to Steel – Release Liner Adhesion

• Container Closure Integrity/Ingress Testing• Probe-Tack/Loop-Tack Testing• Shear Testing• Penetrometer Testing (gels)• Burst/Creep Package Integrity • Hardness Testing

Complete Laboratory Programs• Fee-for-Service Testing Programs• On-site / Off-site Dedicated Staff• Laboratory Capital Equipment• Full-Time Equivalent (FTE) Programs

PacePort is our industry-leading, web-based application that provides instant access to your laboratory information—anywhere, anytime! No software downloads are needed, PacePort is a secure web-based portal that requires only a web browser and PDF Reader.

PacePort provides complete data packages for every project within hours of the final signatures from our Quality Assurance review group. Every page is in high-resolution and in color – easy to read, easy to understand and completely audit-ready. Use PacePort to access every final report and the protocol, procedure, method and data package that supports it.

Why Partner With Pace Analytical? Strategic partnering with Pace Analytical is a key accelerator to getting your products to market on time and on budget. Our ability to excel in combining superior performance on the essential laboratory service elements results in the best customer experience in our industry.

Client-friendly Data Delivery and Management: PacePort, our industry-leading online web portal, provides instant access to audit-ready final reports, protocols, procedures, methods and data packages. PacePort is a custom and proprietary tool that represents our continual efforts to refine our data-delivery systems for the convenience of our clients.

Culture of Service: For 35 years Pace Analytical has worked to provide the best service and has developed a reputation for reliable laboratory service delivery. Pace strives to establish partnerships with each client to better understand specific needs. By establishing long-term relationships, the best interests of both the client and Pace are met.

Integrity: Pace Analytical recognizes that our product is information. Our mission, purpose and values set high standards for all employees and define the open and honest culture under which Pace operates. Our core values ensure the integrity of all data generated by Pace.

Flexible Response to Demand: Pace is committed to providing services to all clients, large or small. Service models include fee-for-services, dedicated resource programs, full-time equivalent (FTE) model on-site at PLS, and/or FTE programs at the client site, which allow for economical options to meet business demands.

Quality: Both of our laboratories have long histories of successful regulatory agency, client and third-party audits. All data goes through 100% independent review by Quality Assurance technical data review specialists before it is released and reported.

L I F E S C I E N C E S

GMP LABORATORYTESTING SERVICES

Chemistry | MicrobiologyPhysical Testing | Stability Storage

PHARMACEUTICALS

MEDICAL DEVICES

DRUG - DEVICE COMBINATION PRODUCTS

I M P R O V I N G O U R H E A L T H

Company Profile_LifeSciences_AUGUST2014_Rev4

Minnesota Life Sciences1311 Helmo Avenue NoOakdale, MN 55128 P: 651.738.2728 F: 651.714.9360www.pacelabs.com

Puerto Rice Life SciencesP.O Box 325Calle B & Calle CEl Retiro Industrial ZoneSan German, PR 00683 P: 787.892.2650F: 787.892.1054

At Pace, we strive to deliver what our customers value most to help them succeed —integrity, reliability, technical expertise and market strength

of a highly respected industry veteran.

For the past 35 years, Pace Analytical has operated one of the largest full-service commercial contract laboratory networks in the nation, providing support for thousands of industry, consulting, and regulatory professionals in many industries. Our investments in laboratory facilities, technology, training and staffing, along with our extensive experience in laboratory testing, demonstrate our commitment to providing comprehensive, consistent and reliable analytical services. Pace Analytical has more than 1,500 employees in 36 locations nationwide.

For the past eight years, Pace Analytical Life Sciences, a division of Pace Analytical Services, has supported the pharmaceutical and medical device industries. Life Sciences operates two cGMP compliant facilities: one located in Oakdale, Minnesota, and the other located in San German, Puerto Rico. Our Oakdale, MN facility is 60,000 square-feet, ISO/IEC 17025:2005 accredited and houses over 110 employees. Our laboratory in San German, Puerto Rico, is 12,000 square-feet and houses more than 70 employees.