Pace Life Sciences LLC, a central laboratory and contract development and manufacturing organization, received an “overall positive review” from the Food & Drug Administration (FDA) after a comprehensive three-day inspection of its San Germán laboratory’s quality systems and data delivery processes. Read more here.
Long-standing reputation for robust quality is confirmed as company enters 2024 SAN GERMAN, PR., March 28, 2024 (NEWSWIRE.COM): Pace® Life Sciences, LLC, a full-service FDA-registered central laboratory and contract development and manufacturing organization (CDMO) announced the receipt of an overall positive review from The Food & Drug Administration (FDA), following a three-day general inspection of …
San German, PR Manufacturing support comes from this FDA-registered laboratory. Our teams have proven expertise and a strong track record of supporting the pharmaceutical and medical device clients on the island. Central laboratory services and mobile on-site facility support programs are supported from this location. Contract Research Organization (CRO) FDA-registered DEA-registered 22,000 ft² of Lab …
Philadelphia, PA Drug development services from this site advance candidates from early pre-formulation and tox studies to an IND filing and on through the clinical phases. Our GMP clinical supplies manufacturing capabilities include oral solid/liquid and topicals capabilities, and clinical packaging and kitting for a variety of molecules/dosage forms. Contract Development Manufacturing Organization (CDMO) 33,000 …
South New Berlin – NY Our teams have proven expertise supporting commercial small molecule programs from this FDA-registered laboratory site. All aspects of GMP commercial chemistry services to support Method Development and Validation, Raw Materials Clearance Programs, Finished Product Release Testing Programs, ICH Stability Storage & Testing, Cleaning Verification studies, and Reference Standard Programs, CONTRACT …
Lebanon, NJ Supporting a wide spectrum of small and large molecule analytical services, formulation development, and early-stage drug product manufacturing services. The Lebanon, New Jersey location offers FDA-registered central laboratory services, including analytical chemistry, microbiology, container closure integrity testing (CCIT), sterility, and other packaging and delivery testing services.
Salem, NH Drug development services from this site advance candidates from early pre-formulation and tox studies to an IND filing and on through the clinical phases. Our GMP clinical supplies manufacturing capabilities include sterile fill-finish and clinical packaging and kitting. Our teams have proven expertise with small molecules, biologics (such as proteins, peptides, antibodies, antibody …
Oakdale, Minnesota – Headquarters Commercialization and manufacturing support comes from this FDA-registered laboratory. Our teams have proven expertise with small molecules, biologics (such as proteins, peptides, antibodies, antibody drug conjugates) and gene therapies (such as RNA and DNA oligos). Contract Research Organization (CRO) FDA-registered DEA-registered 50,000 ft² of Lab Space Analytical Testing for More Than …
Additional CDMO Clinical Manufacturing Location: 29235 Lorie Lane Wixom, MI 48393
Boston, MA Drug development services advance candidates from early pre-formulation and tox studies to an IND filing and on through the clinical phases. Our teams have proven expertise with small molecules, biologics (such as proteins, peptides, antibodies, antibody drug conjugates) and gene therapies (such as RNA and DNA oligos). Contract Research Organization (CRO) 22,000 ft² …