Services for Pharma and Life-Science

 

 


GMPGood Manufacturing Practice

 

We offer consultancy and training in EU-GMP and U.S-GMP as well as assistance at preparing and presenting in FDA audits, and GMP inspections by other authorities or customers.

The following section provides more detailed GMP information (alphabetical order):

BIOTECH
We provide consultancy on all aspects of the biotechnological production and compliance testing of raw materials, intermediate materials and finished products. Our services include the verification | qualification of the infrastructure, risk management, validation of systems and equipment, cleaning validation, validation of analytical methods and method transfer. We are guided by the latest government policies and the validation of models of the ISPE GAMP 5. Further we consider "Good Engineering Practice" according to ASTM E2500 "Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment" and foster the risk-based approach acording to ICH Q9 "Quality Risk Management".
MEDICAL DEVICES | IN-VITRO DIAGNOSTICS (IVD)

We provide consultancy for all compliance and regulatory issues of Medical Devices and In Vitro Diagnostics (IVD) for Europe and USA. We support the entire development process, participate in design meetings, abalance essential quality issues and perform risk analyzes. We facilitate services as supplier evaluation and audits as well as regulatory activities. As applicable, we consider the American laws 21 CFR 820, as well as DIN EN ISO 13485 and DIN EN ISO 14971.

Medical Devices

For Europe, we offer the following topics:

  1. Support of the CE marking process
  2. Classification and evaluation of the medical device
  3. Assistance in determining the suitability for use in accordance with DIN EN IEC 62366
  4. Support and documentation throughout the product life cycle
  5. Construction and maintenance of a Medical Device Vigilance System in accordance with MEDDEV 2.12.1 rev6
  6. External medical consultants pursuant to § 30 MPG
  7. External Quality Management Representative (QMR)
  8. Proactive support for the Post Market Surveillance (PMS), according to MDD 93/42/EEC (amended by 2007/47/EC)

For the U.S., we offer registration services by our CMC Office in Knoxville, TN, United States.

PHARMA

The batch-oriented quality system in the pharmaceutical industry, the GMP "Good Manufacturing Practice" is monitored by the GMP inspectors in the respective German state. For product registrations outside of Europe the relevant state laws apply to monitoring and control.

We provide consultancy on all aspects of GMP and additional QP-services. This is an external "Qualified Person" (QP) - that is a competent person who carries out the regular work and takes responsibility in accordance with § 14 AMG on a freelance basis.

Given the special importance of quality management for the interpretation, definition, specification and verification of quality requirements, we set much emphasis on targets that are scheduled with "intelligence, practical reason and critical judgment" (according to Immanuel Kant, 1788). Translated to the present time, the proposed measures should be based on scientific knowledge, implementable and assessed by risk-based approaches - so they can be accepted by all parties, including the authority.