PCI Pharma Services

Bedford, NH, United States · Tredegar, United Kingdom
Sterile Fill-Finish Biologics Oral Solid Dose Clinical Trial Manufacturing Packaging & Labeling
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3) ○ Clinical Trials ○ SEC Filings ✓ Press (10) ○ EMA GMP ✓ MHRA GMP (4) ✓ HC GMP (7)

Quick Facts: PCI Pharma Services

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
Bedford, NH, United States · Tredegar, United Kingdom
Website
Modalities
Sterile Fill-Finish, Biologics, Oral Solid Dose, Clinical Trial Manufacturing, Packaging & Labeling
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About PCI Pharma Services

PCI Pharma Services is a contract development and manufacturing organization (CDMO). Capabilities: Sterile Fill-Finish, Biologics, Oral Solid Dose, Clinical Trial Manufacturing, Packaging & Labeling. 2 manufacturing sites registered with the U.S. FDA, the UK MHRA and Health Canada: Bedford, NH (formerly Lyophilization Services of New England, LSNE) and Tredegar, Wales (Penn Pharmaceutical Services). Website: https://pci.com/

Signal Score

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

PCI Pharma Services FDA Inspection History

2026-06
2024-05
2022-04
NAI VAI OAI
Date Site Type Observations Classification
2026-06-10
Lyophilization Services of New England, Inc.
Bedford, New Hampshire Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2024-05-24
Lyophilization Services of New England, Inc.
Bedford, New Hampshire Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2022-04-01
Penn Pharmaceutical Services Limited
Tredegar Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Nov 01, 2026

PCI Pharma Services MHRA GMP Compliance 4 certificates

2025-03
2025-03
2022-03
2013-05
Compliant Non-Compliant
Certificate Site City / Postcode Inspection Date Status
UK MIA 4351 Insp GMP/IMP 4351/15302-0033[H] PENN PHARMACEUTICAL SERVICES LIMITED TREDEGAR NP22 3AA 2025-03-26 COMPLIANT
UK MIA(IMP) 4351 Insp GMP/IMP 4351/15302-0033[I] PENN PHARMACEUTICAL SERVICES LIMITED TREDEGAR NP22 3AA 2025-03-26 COMPLIANT
UK ManA 4351 Insp GMP/GDP/IMP 4351/15302-0031[V] PENN PHARMACEUTICAL SERVICES LIMITED TREDEGAR NP22 3AA 2022-03-28 COMPLIANT
UK GMP 42472 Insp GMP 42472/8434985-0002[H] LYOPHILIZATION SERVICES OF NEW ENGLAND INCORPORATED 03110 2013-05-22 COMPLIANT
Source: MHRA GMDP Database · Retrieved Nov 01, 2026

Japan-accredited overseas site (PMDA)

sterile, general (non-sterile) · 3 sites

  • Tredegar, United Kingdom · Penn Pharmaceutical Services Limited (2 sites) — general (non-sterile) · valid to Sep 24, 2029
  • Bedford, United States · Lyophilization Services of New England, Inc. — sterile · valid to Dec 7, 2026 renewal filed

PMDA accreditation of a foreign manufacturing site is recognition within Japan's regulatory system, not an inspection outcome. PMDA's list covers only manufacturing sites outside Japan, so a company's plants in Japan are not on it. Source: PMDA, list of accredited/registered foreign manufacturers (as of Oct 16, 2026), Public Data License 1.0 (terms)

Hiring Activity 100+ open roles Beta

From public job postings on PCI Pharma Services' careers board, as of Oct 31, 2026. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
100+
open roles (the board lists only its ~100 newest)
72
in manufacturing, quality, PD/MSAT, engineering or regulatory (72%)
Trend from Nov 29, 2026
Tracking started Oct 30, 2026. 30-day change shows after 30 days, 90-day after Jan 28, 2027.
Since Oct 30, 2026: 13 new postings, 13 taken down.
What this may mean
  • 7 of the 20 openings at Bedford NH USA are in quality (QA/QC). That fits added testing or batch-release work, but it can also be normal turnover.
By function
Manufacturing & operations 32
Quality (QA / QC) 19
Process development & MSAT 4
Regulatory 1
Engineering & facilities 16
Commercial, BD & client projects 5
Other (finance, HR, IT, other) 23
By site
Rockford IL USA
7 mfg/ops · 4 QA/QC · 2 PD/MSAT · 7 eng. · 14 other
34
Bedford NH USA
8 mfg/ops · 7 QA/QC · 1 PD/MSAT · 3 eng. · 1 other
20
San Diego CA USA
5 mfg/ops · 2 QA/QC · 4 other
11
Stamullen Co Meath IRL
2 mfg/ops · 6 eng. · 1 other
9
Leon Spain
3 mfg/ops · 3 QA/QC · 1 other
7
Philadelphia PA USA
2 mfg/ops · 1 PD/MSAT · 3 other
6
Madison WI USA
2 mfg/ops · 1 QA/QC · 2 other
5
+ 3 more locations
Notable roles
Associate Director Regulatory Compliance Senior operations / quality role · Stamullen Co Meath IRL
Director, QC, Microbiology Senior operations / quality role · San Diego CA USA
Latest postings
Talent Acquisition Specialist Other (finance, HR, IT, other) · Tredegar UK
Sr Automation Engineer Engineering & facilities · Bedford NH USA
QC SAMPLE COORDINATOR l Quality (QA / QC) · Bedford NH USA
Manager, Continuous Improvement, Global OpEx Manufacturing & operations · Rockford IL USA
Maintenance Mechanic 3, Linden Rd Engineering & facilities · Rockford IL USA
Maintenance Mechanic 2, Weekend B, Fri, Sat, Sun, 7pm 7am Engineering & facilities · Rockford IL USA
Maintenance Mechanic 2, 2nd Shift Engineering & facilities · Rockford IL USA
Maintenance Mechanic 2, 2nd Shift Engineering & facilities · Rockford IL USA
MTS Manager Other (finance, HR, IT, other) · Madison WI USA
Leave, Accommodations Specialist Other (finance, HR, IT, other) · Rockford IL USA
Global Data Analyst, OpEx Manufacturing & operations · Rockford IL USA
Director, QC, Microbiology Quality (QA / QC) · San Diego CA USA
Coverage: counted from PCI Pharma Services' own careers board. The board publishes only its ~100 newest postings, so the real number of open roles is likely higher. Function groups come mainly from job titles (about 84% match a hand check), and modality words from titles only, so both are approximate.
Source: pciservices.wd1.myworkdayjobs.com · Checked Oct 31, 2026 · Tracking since Oct 30, 2026

Company Signals 10 articles

Company announcements, not verified evidence. They do not change any score.
news Wed, 29 Ap
PCI Pharma Services makes $1B investment to scale injectable manufacturing, device assembly - megaproject.com
news Tue, 15 Ju
PCI, on CDMO growth journey, nets 'sizable' investment from private equity heavyweights - Fierce Pharma
news Thu, 28 Au
PCI Pharma Services completes acquisition of Ajinomoto Althea - Pharmaceutical Technology
news Thu, 12 Fe
CDMOs Roll Out Expansions for Parenteral Drugs - DCAT Value Chain Insights
news Thu, 11 Se
PCI Pharma Services Receives Strategic Investment from Bain Capital, Kohlberg and Mubadala - Contract Pharma
news Thu, 07 Au
Bain Capital expects PCI to benefit from nearshoring dynamics in biopharma - pehub.com
news Mon, 27 Ap
Backed by Investments Exceeding $1 Billion, PCI Pharma Services Announces Major Expansion of US Sterile Fill-Finish and Drug-Device Delivery Combination Capabilities - Business Wire
news Mon, 27 Ap
PCI Pharma Services Expands U.S. Sterile Manufacturing and Drug-Device Capabilities in $1B+ Global Investment Program - citybiz
news Mon, 14 Ju
Private equity firms back PCI Pharma in bet on drug production - BioPharma Dive
news Fri, 10 Ap
An integrated path: how CDMOs are reshaping complex drug development - Manufacturing Chemist

Frequently Asked Questions About PCI Pharma Services

How many FDA inspections does PCI Pharma Services have on record?
CDMO Signal tracks 3 FDA inspections for PCI Pharma Services, sourced from the FDA inspection database. See the full inspection history above.
Has PCI Pharma Services received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for PCI Pharma Services.
Does PCI Pharma Services hold EMA or MHRA GMP certificates?
CDMO Signal tracks 4 MHRA GMP certificates for PCI Pharma Services.
Does PCI Pharma Services have a CDMO Signal Score?
Not yet. PCI Pharma Services is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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