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Advances small-molecule, biologics, and gene-therapy candidates from early pre-formulation through clinical phases. Previously known as Wolfe Labs.

Location: 19 Presidential Way, Woburn, MA 01801

Function: CDMO

Lab size: 22,000 ft²

Certifications / Registrations: GLP compliant, DEA-registered

Boston, MA DEA Registration – Researcher

DEA Registration Number: RT0536500

Controlled Substances Permit – Woburn, MA

Registration Number: MT1128188K

Services:

• Pre-formulation characterization of novel molecules
• Formulation development
• Full analytical support
• Tox supplies
• Lyophilization process development

Supports liquid and topical drug products from formulation development through non-sterile clinical supply manufacturing. Previously known as Velesco pharma.

Location: 28036 Oakland Oaks Ct., Wixom, MI 48393

Function: CDMO

Lab size: 16,000 ft²

Certifications / Registrations: GMP manufacturing facility

Services:

• Formulation development
• Analytical development
• Non-sterile clinical supply manufacturing
• Liquid-in-capsule filling

Provides FDA-registered contract research and manufacturing support for small molecules, biologics, and gene therapies. Founded as the original Pace® Life Sciences laboratory, then later expanded through the acquisition of P3 Scientific, Inc.

Location: 1311 Helmo Avenue North, Oakdale, MN 55128

Function: CRO

Lab size: 60,000 ft²

Certifications / Registrations: FDA-registered; DEA-registered

Oakdale, MN DEA Registration – Analytical Lab

DEA Registration Number: RP0352512

ISO 17025 Scope of Accreditation and Certificate – Oakdale, MN

Certificate Number: AT-1214

Florida Drugs, Devices and Cosmetics License

FDA EIR – PLS Oakdale MN

Services:

• Raw materials clearance programs
• Methods development and validation
• In-process and finished product release testing
• ICH stability programs
• Reference standards programs
• Extractables and leachables
• Full microbiology laboratory support (sterile and non-sterile product support)

Provides FDA-registered CRO laboratory support for life sciences clients, from the Research Triangle Park area. Previously operated by Catalent.

Location: 160 N Pharma Drive, Morrisville, NC 27560

Function: CRO

Lab size: 63,000 ft2

Certifications / Registrations: GMP-aligned laboratory practices, FDA-registered; DEA-registered

Morrisville, NC DEA Registration – Analytical Lab

DEA Registration Number: RP0706260

Services:

• CRO laboratory services
• Life sciences laboratory support

Sterile Fill-finish Center of Excellence. Delivers clinical manufacturing, including sterile fill-finish, and clinical packaging and kitting, from a GMP facility in NH. Previously known as Bio-Concept Laboratories.

Location: 13 Industrial Way, Salem, NH 03079

Function: CDMO

Lab size: 30,000 ft²

Certifications / Registrations: GMP-compliant; DEA-Registered

Salem, NH DEA Registration – Manufacturer

DEA Registration Number: RP0662608

New Hampshire Board of Pharmacy License

Services:

• Formulation development
• Process development
• Full analytical support
• Aseptic manufacturing for ophthalmic, otic and injectable products
• Toxicology-enabling materials
• Phase 1 and Phase 2 clinical trial materials
• Niche commercial manufacturing

Supports small- and large-molecule analytical services, formulation development and early-stage drug product manufacturing. Previously known as Whitehouse Analytical Laboratories and operated by Curia.

Location: 291 US Highway 22, Lebanon, NJ 08833

Function: CRO

Lab size: 40,000 ft²

Certifications / Registrations: GMP analytical laboratory, FDA-registered; DEA-registered

Lebanon, NJ DEA Registration – Analytical Lab

DEA Registration Number: RP0709824

ISO 17025 Scope of Accreditation and Certificate – Lebanon, NJ

Certificate Number: L2388

Services:

• Small- and large-molecule analytical services
• Formulation development
• Early-stage drug product manufacturing
• Analytical chemistry
• Microbiology
• Container closure integrity testing (CCIT)
• Sterility
• Packaging and delivery testing

Provides FDA- and DEA-registered analytical laboratory and manufacturing support services for pharmaceutical and medical device clients in Puerto Rico.

Location: San German, San German, PR 966

Function: CRO

Lab size: 22,000 ft²

Certifications / Registrations: FDA-registered; DEA-registered

San German, PR DEA Registration – Analytical Lab

DEA Registration Number: RP0558405

Puerto Rico Drug License

San German, PR FDA EIR, Oct-Nov 2017

San German, PR FDA Response, Oct-Nov 2018

Services:

• Chemistry and microbiology laboratories
• Raw materials clearance programs
• In-process and finished product testing
• ICH stability programs
• Facility and environmental monitoring programs
• Cleaning verification and disinfectant efficacy studies