Validate laboratory and production equipment
Pharma Engineering ApS is a leading provider of comprehensive validation and qualification services within the pharmaceutical manufacturing sector. Located in Roskilde, DK, Pharma Engineering ApS specializes in ensuring the reliability and compliance of laboratory and production equipment, ranging from individual units to complete packaging lines, encompassing both simple and highly computerized systems. Their expertise covers a broad spectrum of services, including Golden ~ Light Qualification, authoring and reviewing qualification documents, and conducting thorough deviation investigations. Pharma Engineering ApS also provides invaluable support in areas such as protein analysis, cost-benefit calculations, and transferring Research and Development methodologies into production records for regulatory filings. With a commitment to stringent GMP regulations, Pharma Engineering ApS helps clients navigate the complexities of pharmaceutical manufacturing with confidence. Pharma Engineering ApS's team of experienced professionals are adept at estimating time and costs associated with new equipment, personnel training, and the transfer of analytical methods. Pharma Engineering ApS is dedicated to upholding the highest standards of quality and compliance within the pharmaceutical industry, offering reliable solutions to meet the ever-evolving regulatory landscape. We invite you to contact Pharma Engineering ApS to explore how we can support your operational excellence.
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Compare Pharma Engineering ApS with 3 companies in Pharmaceutical-Manufacturing
| Comparison Field |
Ph
Pharma Engineering ApSMain Company |
PQE GroupView Profile |
IPS-Mehtalia Pvt. Lt...View Profile |
HEISView Profile |
|---|---|---|---|---|
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Founded Year
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— | 1998 | 2011 | 2011 |
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Company Size
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— | 1,001-5,000 | 1,001-5,000 | 2-10 |
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City
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Reggello, FI | Mumbai, Maharashtra | Freiburg im Breisgau, Baden-Württemberg | |
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Country
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Italy | India | Germany | |
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Skills & Keywords
Comparing with main company
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9 Total Skills
Pharmaceutical Manufacturing
Validation Services
Qualification
GMP Compliance
Equipment Validation
Regulatory Compliance
Pharmaceutical Equipment
Validation
21CFR Part 11
|
21 Total
21 Unique
Unique Skills:
21 CFR Part 11
Audit
Biotech
Compliance
CSV
Cybersecurity
+15
|
6 Total
6 Unique
Unique Skills:
Architectural Planning & Design
Civil Engineering
Commissioning
Construction Management
Engineering
Technical Consulting
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18 Total
18 Unique
Unique Skills:
Analysis
Consultation
Development
DHF
EU MDR 2017
FDA 21 CFR 820
+12
|
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