What Prime Life Sciences does

Prime Life Sciences is a Basel, Switzerland-based specialized consulting company serving the pharmaceutical, biotechnology, and medical device industries. Founded in 2020, it operates as the Life Sciences-focused subsidiary of Prime Group, a diversified European engineering and digital transformation conglomerate comprising 14 companies, 31 offices, and more than 3,000 professionals across 58 nationalities. The company delivers end-to-end services across the product and service lifecycle, organized into three vertical practices: Pharmaceutical, Biotech, and Medical Devices.

The service portfolio spans technical services (equipment qualification, process validation, formulation, scale-up, engineering from concept to detailed design covering HVAC, mechanical, instrumentation, PLC, SCADA/HMI, MES), quality assurance and control (GxP, ICH, CAPA, deviation, change control, supplier QA, analytical method development), regulatory affairs (CTD/eCTD writing and submission to FDA, EMA and other health authorities, pharmacovigilance, CE marking, 510(k), EU MDR/IVDR), and project management (clinical operations, tech transfer, CMO management, green/brown field projects, audit readiness). The company holds a broad compliance and certification footprint including ISO 13485, ISO 14971, ISO 62366, 21 CFR Part 820, EU MDR, GxP, ICH, GDPR, and CSA STAR Level 1.

Prime Life Sciences makes money through professional services and consulting engagements delivered to life sciences companies, with revenue derived from billable consultant time, project-based fees, and managed service arrangements covering validation, quality, and regulatory work. Its go-to-market is direct client engagement via a 'Talk with us' contact channel and consultant recruitment through a dedicated job portal, with a top-of-funnel social presence on LinkedIn, Facebook, and Instagram. Customer segments are vertical (pharma, biotech, medical devices) rather than horizontal, and the company emphasizes client confidentiality, transparent delivery against quality, deadline, and budget parameters, and close working relationships between clients and consultants.

Name

Prime Life Sciences

Website

https://primelifesciences.ch

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Specialized Life Sciences consulting company providing technical, quality, regulatory, and project management services to pharmaceutical, biotech, and medical device firms. Operates as the Life Sciences subsidiary of European engineering conglomerate Prime Group, headquartered in Basel, Switzerland.

Ownership category

akta.pro rank

Product category

Life Sciences Consulting

NAICS

Management, Scientific, and Technical Consulting Services (5416), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Life Sciences & Biotech (R&D/Clinical) Staffing (BPACADAL)

akta.pro secondary industries

CMC Regulatory Affairs (Modules 2/3, Variations, Post-Approval CMC) (HLAGAKAB), CMC, Process Development & Tech Transfer Staffing FSP (HLAGAOAK)

Keywords

• Pharmaceutical consulting
• Biotech consulting
• Medical device consulting
• Regulatory affairs services
• Quality assurance consulting

Headquarters

HQ city

Basel

HQ country

Switzerland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Marketing channels3 records

Core offering

Prime Life Sciences provides specialized consulting services across the pharmaceutical, biotechnology, and medical device industries. Its service portfolio spans the full product and project lifecycle, including technical services (equipment qualification, process validation, formulation, scale-up, USP/DSP processing, engineering from concept to detailed design), quality assurance and regulatory affairs (GxP, ICH, CTD/eCTD submissions to FDA and EMA, CE marking, 510(k), MDR/IVDR, pharmacovigilance), and project management (clinical operations, tech transfer and CMO management, green/brown field projects, supervision, commissioning, and audit readiness).

Product overview

Prime Life Sciences is a specialized consulting/services company offering a comprehensive suite of services across three main areas: Pharmaceutical, Biotech, and Medical Devices. Their service portfolio includes technical services (equipment qualification, process validation, engineering), quality assurance and regulatory affairs, and project management. These three service lines work together to support clients throughout the entire lifecycle of services and products in the Life Sciences industry, providing end-to-end consulting from development through commercialization and compliance.

Differentiator

Problem solved

Functional benefit

Products and services

• Pharmaceutical Services Comprehensive consulting services for pharmaceutical companies covering technical services (formulation, scale-up and transfer, CMO management, engineering from concept to detailed design including HVAC/utilities, mechanical, instrumentation, PLC, SCADA/HMI, MES, equipment qualification DQ/IQ/OQ/PQ, process validation, cleaning validation CIP/SIP/COP, computer system validation), quality management system (GxP, ICH), quality assurance (CAPA, deviation, change control, batch record review, external supplier QA), quality control (analytical method development/validation, stability, lab qualification), regulatory affairs (CTD/eCTD Modules 3-5, FDA/EMA submissions, variations, pharmacovigilance), and project management (clinical operations, tech transfer/CMO management, green/brown field projects, capex/procurement/HSE, supervision/commissioning/troubleshooting, audit readiness).
• Biotech Services Consulting services for biotechnology companies covering USP and DSP process development (calculation, sizing, equipment tendering and selection), external supplier QA management, pharmacovigilance, tech transfer and CMO management, plus the full engineering, qualification, validation, quality, regulatory (GxP, ICH, CTD/eCTD submissions to FDA/EMA), and project management stack supporting biotech product lifecycles.
• Medical Devices Services End-to-end consulting for medical device development and commercialization covering product development for Class I, II, and III devices, combined products, diagnostic tools, and implants; process development, qualification and validation; quality management system implementation; regulatory compliance (CE marking, 510(k), MDR, IVDR); Design Control and History File per 21 CFR Part 820; risk management per ISO 14971; human factors engineering per ISO 62366; verification and validation; and post-market monitoring.

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

One partnership is on record.

• Prime GroupcoreStrategic or Co-development PartnerPrime Life Sciences is a subsidiary company of Prime Group, an international group with over 18 years of experience in Engineering, Innovation and Digital Transformation. Prime Group encompasses 14 companies with 31 offices across Europe, over 3000 qualified professionals, and 58 nationalities. Prime Life Sciences operates under the Prime Group umbrella as a specialized Life Sciences consulting company.

Recent moves4 records

Expansion highlights4 records

Broad incumbents

• Syneos Health: Clinical and commercial services organization serving pharma and biotech across development, regulatory and post-launch. Comparable scale of services against Prime Life Sciences' biotech and pharma practices, especially clinical operations and regulatory.
• ZS Associates: Global consulting firm with a large life sciences practice covering commercial, R&D, regulatory and digital transformation. Comparable as a strategic consulting alternative bidding on the same type of life sciences transformation mandates.
• Accenture (Life Sciences practice): Global consultancy with a dedicated Life Sciences practice covering regulatory, quality, pharmacovigilance and digital transformation. Direct competitor for multi-disciplinary life sciences consulting mandates.
• ICON plc: Global CRO and consulting services provider to pharma and biotech. Comparable on regulatory/quality and clinical operations services that overlap with Prime Life Sciences' pharma and biotech verticals.
• IQVIA: Largest global CRO and life sciences consulting platform offering regulatory, quality, clinical, and technology services. Directly comparable as a full-scope life sciences services incumbent; Prime Life Sciences competes for the same consulting wallet at a far smaller scale.
• Cognizant Life Sciences: IT and consulting services arm serving pharma/biotech with regulatory, clinical, lab informatics and quality services. Comparable as a large-scale partner for regulated industry consulting and digital enablement.
• Charles River Laboratories: Global CRO/CDMO offering research models, discovery, safety assessment and manufacturing services. Comparable as a broad life sciences services incumbent with adjacent consulting/CDMO capabilities relevant to biotech clients.

Direct peers

• QbD Group: Specialized life sciences consultancy focused on CMC, qualification, validation and quality. Closely comparable to Prime Life Sciences' CMC, process development, equipment qualification and tech-transfer services.
• Alira Health: Mid-sized life sciences consulting firm spanning regulatory, clinical, real-world evidence and digital health. Comparable scope (pharma/biotech/medtech) and size tier to Prime Life Sciences.
• PharmaLex (now part of Cencora/Allergan Aesthetics): Specialist regulatory, quality and compliance consulting firm serving pharma and biotech. Highly comparable service mix — regulatory affairs, QA, submissions, pharmacovigilance — directly mirroring Prime Life Sciences' pharma and biotech verticals.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/PrimeLifeSciences
• LinkedInlinkedin.com/company/primelifesciences
• Instagraminstagram.com/PrimeLifeSciences

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Prime Life Sciences