HHAC Labor Dr. Heusler GmbH

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HHAC Labor Dr. Heusler GmbH


Profile

Lab Biography

Independent pharmaceutical contract laboratory in Germany specialized in GMP analytical services, quality control and stability testing.

Qualifications

HHAC Labor Dr. Heusler operates under strict regulatory and quality standards to ensure reliable and compliant analytical and manufacturing services.

Key qualifications and authorizations include:

  • GMP Manufacturing Authorization (Herstellungserlaubnis) in accordance with applicable European and German pharmaceutical regulations
  • Implementation of a robust quality management system (QMS) aligned with pharmaceutical industry requirements
  • Regular inspections by competent authorities to ensure ongoing compliance with Good Manufacturing Practice (GMP) standards
  • Participation in proficiency testing and interlaboratory comparisons to maintain high analytical accuracy and reliability
  • Highly qualified scientific personnel with extensive expertise and continuous professional development
  • Compliance with relevant national and European regulatory frameworks for laboratory and manufacturing activities

Further details on specific authorizations and regulatory scope are available upon request.

Standards & Methodologies

HHAC Labor Dr. Heusler applies scientifically sound, state-of-the-art analytical methodologies in accordance with recognized international guidelines and regulatory expectations.

Our laboratory services are based on:

  • Analytical methods aligned with current pharmacopoeial standards (e.g. Ph. Eur., USP, where applicable)
  • Development, validation, and routine application of methods following ICH guidelines (e.g. ICH Q2 for analytical validation)
  • Application of GMP-compliant procedures throughout all relevant laboratory and manufacturing activities
  • Use of modern instrumental techniques such as chromatography (HPLC, GC), spectroscopy, and complementary physicochemical testing methods
  • Dissolution testing for pharmaceutical dosage forms in accordance with regulatory and pharmacopoeial requirements
  • Conduct of stress testing and forced degradation studies to evaluate substance stability and degradation pathways
  • Performance of photostability studies in line with ICH Q1B guidelines
  • Stability studies with storage in controlled climate chambers, including qualified storage conditions and continuous monitoring
  • Capability for storage and handling of controlled substances (narcotics) in compliance with applicable legal requirements
  • Safe handling and analytical testing of highly potent and CMR substances under appropriate containment and safety measures
  • Structured method transfer and verification processes to ensure robustness and reproducibility
  • Comprehensive documentation and data integrity practices in line with regulatory expectations (e.g. ALCOA+ principles)

All activities are performed using validated systems and under controlled conditions to ensure high-quality, consistent, and traceable results.

Industry Types Served

  • Pharmaceuticals & Biopharmaceuticals

Lab Testing Types Offered

  • Analytical & Quality Control Studies
  • Appearance & Visual Assessment
  • Appearance Testing
  • Chemistry & Compound Analysis
  • Chromatography & Spectroscopy
  • Container & Closure Integrity Testing
  • Contaminants, Adulteration & Purity
  • Dimensional & Density Measurements
  • Environmental & Regulatory Testing
  • Extractables, Leachables & Impurity Testing
  • Flow & Rheology Testing
  • Formulation & Drug Release Studies
  • Light Stability & Optical Performance Studies
  • Metals & Inorganic Analysis
  • Microscopy & Imaging
  • Optical & Light-Based Microscopy
  • Optical Testing
  • Optical Transmission & Reflection Testing
  • Organic Compound Analysis
  • Pharmacology & Drug Development
  • Physical Testing
  • Physicochemical & Materials Properties
  • Refractive & Dispersion Properties Analysis
  • Stability & Shelf-Life Studies
  • Thermal Stability & Oxidation Resistance Testing

Location

Stutensee, Germany

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