Alphalytik Pharmaservice

What Alphalytik Pharmaservice does

Alphalytik Pharmaservice GmbH is a Berlin-based, GMP-certified pharmaceutical contract laboratory founded in 1995 that delivers analytical testing services to pharmaceutical, biotechnology, nutrition, and medicinal cannabis manufacturers. Its core offerings are stability studies conducted under ICH-defined climate conditions, batch release testing covering raw materials through finished dosage forms, and GMP compliance consulting including audit preparation and staff training. The lab operates a comprehensive instrument footprint that includes HPLC, UPLC, capillary electrophoresis, thin-layer chromatography, dissolution and disintegration testers, friability and tablet hardness testers, particle counters, osmometers, nephelometers, Karl Fischer titrators, and ICH climate, UV, and stress chambers, with all work executed under Ph. Eur., USP, and DAB standards and FDA registration maintained for more than 30 years.

The company has built differentiated capability in regulated medicinal cannabis stability testing, leveraging high-security storage infrastructure and German Narcotics and MedCanG licensing to serve BfArM-compliant cannabis producers and importers. Alphalytik is a subsidiary of the CERTANIA Group, a global testing, inspection, and certification conglomerate founded in 2020, and operates as a privately held GmbH headquartered at Grünberger Straße 44A, Berlin, under CEO Dr. Nicolas Schauer.

Commercially, Alphalytik runs a B2B professional services model: revenue is generated through quote-based, project-specific contracts and multi-year engagements with no publicly disclosed pricing tiers. Go-to-market is direct enterprise field sales augmented by inbound website leads, industry-event participation, and cross-referrals within the CERTANIA network. The primary customer segments are pharmaceutical and biotechnology manufacturers needing GMP, ICH, and pharmacopoeia compliance for release and shelf-life decisions; medicinal cannabis producers and importers form a secondary, more specialized vertical. Service delivery is performed exclusively in-house at the Berlin facility, with the company advertising cumulative throughput of 6,784 projects completed and over 3.5 million tablets analyzed across its operating history.

Name

Alphalytik Pharmaservice

Legal name

Alphalytik Pharmaservice GmbH

Website

https://alphalytik.com

Company type

Private

Founded year

1995

Operating status

Operating

Headcount range

11–50 employees

Short description

Alphalytik Pharmaservice is a Berlin-based, GMP-certified contract laboratory that provides ICH-compliant stability studies, batch release testing, and regulatory consulting to pharmaceutical, biotechnology, nutrition, and medicinal cannabis manufacturers across Europe.

Ownership category

akta.pro rank

Product category

Pharmaceutical Analytical Testing Services

NAICS

Testing Laboratories and Services (541380)

SIC

Services-Testing Laboratories (8734)

akta.pro primary industry

Release Testing & Batch Certification (QC) (HLAGADAC)

akta.pro secondary industries

Stability Testing (ICH Programs) (HLAGADAD), Small-Molecule Analytical Development & Method Validation (CMC) (HLAGAHAF), GMP Manufacturing Support Services (QA/QMS, validation, documentation) (HLAAAKAH)

Keywords

• Pharmaceutical analytical testing
• GMP laboratory services
• Stability studies
• Batch release testing
• Medicinal cannabis testing

Headquarters

HQ city

Berlin

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Pharmaceutical Laboratory Testing Services: B2B laboratory services including batch release testing, stability studies, purity/assay testing, dissolution, photostability, and microbiological testing for pharmaceutical and biotech companies. Revenue generated through project-based contracts with no standard pricing publicly disclosed.
2. GMP Consulting Services: Tailored GMP consulting including audit preparation and staff training, ensuring regulatory compliance for pharmaceutical manufacturers.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Alphalytik Pharmaservice is a GMP-certified pharmaceutical analytical laboratory in Berlin providing regulatory-compliant testing services to drug manufacturers and biotech firms. Its core offerings include batch release testing (identity, purity, assay, dissolution, microbiological testing), ICH-compliant stability studies for determining shelf life, specialized GMP stability studies for medicinal cannabis compliant with BfArM and MedCanG, method validation and transfer, and tailored GMP consulting including audit preparation and staff training. All services operate under GMP, ICH, Ph. Eur., USP, and DAB standards.

Product overview

Alphalytik Pharmaservice is a GMP-certified pharmaceutical testing laboratory offering a comprehensive portfolio of analytical services. The core offerings include Batch Release Testing for end-to-end quality verification of pharmaceutical products, Stability Studies across all ICH conditions to determine shelf life and storage requirements, and specialized Stability Studies for Medicinal Cannabis. Supporting these are specialized analytical testing services including assay/purity determination, dissolution, photostability, disintegration, friability, particle sizing, tablet hardness, moisture content (Karl Fischer), turbidity, loss on drying, microbiological testing, and pH measurement. The portfolio is complemented by GMP Consulting for regulatory compliance and audit preparation, and Method Validation/Transfer services. All services operate under GMP, ICH, and international pharmacopoeia (Ph. Eur., USP, DAB) standards.

Differentiator

Problem solved

Functional benefit

Products and services

• Batch Release Testing End-to-end GMP batch release testing for small molecules and biologics from raw materials through finished dosage forms, covering physicochemical testing, identity and purity analysis, potency and assays, dissolution testing, friability, hardness, disintegration, particle sizing, Karl Fischer water content, turbidity, loss on drying, pH, and microbiology (bioburden, sterility, endotoxin) under GMP, ICH, Ph. Eur., USP, and DAB standards.
• Stability Studies Planning and execution of long-term, intermediate, and accelerated stability studies in accordance with ICH guidelines to determine shelf life and storage conditions, performed in state-of-the-art ICH climate chambers with continuous monitoring and documentation, including evaluation and trend analysis and stress/transport simulations.
• Stability Studies for Medicinal Cannabis Fully validated GMP ongoing stability studies for medicinal cannabis in high-security facilities, providing audit-ready shelf-life data required by BfArM and German health authorities, including cannabinoid potency profiling, terpene analysis, and compliance with European Pharmacopoeia cannabis flower monographs and DAB cannabis extract specifications.
• GMP Consulting Tailored GMP consulting including audit preparation and staff training to ensure full compliance with highly complex regulatory requirements (GMP, ICH, pharmacopoeia), delivered as a complementary professional service alongside the core analytical testing portfolio.
• Method Validation and Transfer Seamless integration of existing analytical methods or development and validation of new analytical methods with expert support, enabling clients to qualify methods for GMP use and transfer them between sites for regulatory submissions.

Quantifiable outcome

• 6,784 projects successfully completed over the company's operational history
• +1 more outcomes

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• CERTANIA GroupcoreStrategic or Co-development PartnerAlphalytik is part of CERTANIA, a corporate group specializing in testing, inspection, and certification (TIC) services. CERTANIA was founded in 2020 and quickly grew into a global player uniting leading companies in the TIC sector. Through the merger with CERTANIA, Alphalytik benefits from a global network and innovative infrastructure, enabling it to offer clients more robust, compliant, and sustainable solutions while maintaining the agility of a specialized, medium-sized laboratory.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Catalent: Global CDMO offering pharma and biologics development, manufacturing, and analytical services including stability and release testing. Comparable as a GMP contract analytical services provider to pharma clients.
• Eurofins Scientific: Global leader in contract laboratory testing across pharmaceutical, biopharma, and consumer products. Directly comparable as a GMP-analytical testing services provider with a much broader global footprint and far larger headcount.
• GBA Group: Germany-headquartered contract laboratory group providing pharmaceutical, food, and environmental testing services. Directly comparable in GMP analytical services, method validation, and stability testing from a German base.
• Charles River Laboratories: Global CRO providing pharmaceutical development and GMP-compliant laboratory testing, manufacturing, and quality services across small and large molecules. A direct peer on the biopharma analytical testing/CDMO overlap.
• WuXi AppTec: Global CRO/CDMO offering analytical testing, stability, method validation, and manufacturing services for pharma and biopharma clients. Directly comparable as a contract analytical testing services provider.
• LabCorp / Covance Drug Development: Major global CRO/Central Lab providing pharma development and analytical testing services including bioanalytical, stability, and release testing. Directly comparable on pharma CRO testing scope.
• Eurofins CDMO (formerly Aptuit): Pharmaceutical analytical and small-molecule CDMO services (Aptuit / Eurofins CDMO) offering GMP method validation, stability, and release testing. A focused, directly comparable contract analytical peer.

Broad incumbents

• Intertek Group: Global TIC group providing pharmaceutical and consumer products testing services. Directly comparable to Alphalytik's parent CERTANIA in scope and to Alphalytik's analytical lab offerings.
• ALS Global: International contract laboratory providing life sciences testing, method validation, and stability services. A broad TIC incumbent with pharma-analytical services comparable to Alphalytik's offerings.
• SGS Group: Global TIC conglomerate offering life sciences testing services alongside broader industrial testing and certification. Overlaps with Alphalytik on the lab-testing side but operates a much wider portfolio.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/alphalytik-pharmaservice-gmbh

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Alphalytik Pharmaservice