Alongside adherence with the corresponding GMP standards and regulations, our services include creation and control of regulatory documents for official authorities.

GMP / Quality / Regulation

We take over the creation, review and approval of GMP documents such as SOPs (Standard Operating Procedures) and manufacturing instructions or specifications, ensuring GMP compliance and checking for deviations, change control and OOS before initiating release. We create and control regulatory documents for authorities such as FDA, EMA, PMDA or AGES. We answer queries from regulatory authorities and advise your company during internal and external audits. Where required, we take over business management for the market development, trading and distribution of medical devices. We can help you set up a medical devices company, even if the appropriate qualifications cannot be demonstrated within the team of founders.

GMP (Good Manufacturing Practice)

Based on our experience in laboratory management in the GMP environment for an international pharmaceutical group as well as experience in interim management with well-known pharmaceutical companies, we are in a position to advise you on all aspects related to GMP, Quality and Regulation.

  • manufacturing instructions
  • specifications or evaluation reports
  • GMP documents

Naturally, this includes the creation, review and approval of all types of GMP documents, such as SOPs, manufacturing instructions, specifications or evaluation reports. We have access to a wide variety of SOPs.

GMP (Good Manufacturing Practice)

Based on our experience in laboratory management in the GMP environment for an international pharmaceutical group as well as experience in interim management with well-known pharmaceutical companies, we are in a position to advise you on all aspects related to GMP, Quality and Regulation.

Naturally, this includes the creation, review and approval of all types of GMP documents, such as SOPs, manufacturing instructions, specifications or evaluation reports. We have access to a wide variety of SOPs.

  • manufacturing instructions
  • specifications or evaluation reports
  • GMP documents

Quality

In the production of medicines and active ingredients, it is necessary to guarantee certain quality standards – guidelines for the “quality” of the production processes and the environment – for quality assurance purposes.

  • checking and approval of deviations
  • GMP compliance

This is the only way to ensure product quality and fulfilment of health authorities’ requirements, which are mandatory for marketing the product. We ensure GMP compliance in the relevant areas and oversee checking and approval of deviations, change control or OOS.

Quality

In the production of medicines and active ingredients, it is necessary to guarantee certain quality standards – guidelines for the “quality” of the production processes and the environment – for quality assurance purposes.

This is the only way to ensure product quality and fulfilment of health authorities’ requirements, which are mandatory for marketing the product. We ensure GMP compliance in the relevant areas and oversee checking and approval of deviations, change control or OOS.

  • checking and approval of deviations
  • GMP compliance

Regulation

Our Regulatory Compliance Services include the preparation and control of regulatory documents and regulatory approvals for government agencies such as Food and Drug Administration (FDA), EMA (European Medicines Agency), PMDA (Pharmaceuticals and Medical Devices Agency), and AGES (Austrian Agency for Food Security).

  • preparation and control of regulatory documents
  • regulatory approvals for government agencies

We also support you with the qualified expert responses to administrative questions as well as with internal and external audits. This saves you valuable time.

Regulation

Our Regulatory Compliance Services include the preparation and control of regulatory documents and regulatory approvals for government agencies such as Food and Drug Administration (FDA), EMA (European Medicines Agency), PMDA (Pharmaceuticals and Medical Devices Agency), and AGES (Austrian Agency for Food Security).

We also support you with the qualified expert responses to administrative questions as well as with internal and external audits. This saves you valuable time.

  • preparation and control of regulatory documents
  • regulatory approvals for government agencies

In addition to regulatory support, we also answer your questions about Biosafety.

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