Our services
COMPLIANCE
Design, development, implementation, and maintenance of quality assurance systems: GXP and ISO.
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Human and/or Veterinary Medicines
Discover everything Konexio Biotech can do for your business related to human and/or veterinary medicines.
- Design, development, implementation, and maintenance of quality assurance systems GxP: GMP, GDP, GCP, GLP, and GTP.
- Conducting national and international audits. Internal, external, and supplier audits.
- Support in the opening of pharmaceutical and biotechnology plants.
- Management of the master validation plan and execution: Analytical methods validation, process validation, transportation validation, media-fill...
- Performing computer system validations.
- Quality risk management: ICH Q9 Guideline.
- Support for sterile manufacturing EU GMP Annex 1.
- CAPA follow-up management.
- Design and delivery of annual training plans.
Medical Devices (MDR and IVDR)
Discover everything Konexio Biotech can do for your business related to Medical Devices (MDR and IVDR).
- Design, development, implementation, and maintenance of quality assurance systems: ISO 13485 and ISO 15189.
- Conducting national and international audits. Internal, external, and supplier audits.
- Management of the design and validation plan for software for medical devices.
- Management and preparation of the prior operating license by AEMPS.
- Modification/Renewal of the AEMPS operating license.
- Preparation and execution of the annual review of the quality management system by management.
- Support during Notified Body audits.
- Quality Risk Management: ISO 14971.
Cosmetics
Discover everything Konexio Biotech can do for your business related to cosmetics.
- Design, development, implementation, and maintenance of quality assurance systems: ISO 22716.
- Conducting national and international audits. Internal, external, and supplier audits.
Discover BIOKTECA
Do you want to digitalize your quality system? We have the solution: BIOKTECA
Our work process
Discover the work process we follow at Konexio Biotech to shape your project in a comprehensive way.
Step-01
Defining the Quality System
We evaluate your operational framework and define the applicable quality system for your project.
Step-02
Designing the Quality System
We analyze your work processes and design the best quality system that fits your needs.
Step-03
Drafting and preparing your quality system
We develop the quality system required to carry out your activity.
Step-04
Training your staff
We provide training for your staff on the quality system we have developed.
Step-05
Implementing the quality system
We implement the developed quality system within your facility.
Step-06
Ongoing support
After implementing the quality system, we accompany you through its audit by the relevant authority and maintain it over time.
Do you want to learn more about Compliance?
GMPs are acronym for Good Manufacturing Practices for human and veterinary medicinal products.
Designing a GMP system involves drafting the procedures and documentation related to the quality system, while implementation involves generating validation plans, providing support in the execution of production processes, etc.
Yes, at KONEXIO BIOTECH, we are experts in Advanced Therapies, so we design and implement quality systems specific to Advanced Therapies for both hospitals and laboratories.
Yes, both for warehouses and TAC Laboratories.
Yes, we can also support the implementation of the system, including conducting audits on critical suppliers and during inspection visits by the regulatory body.
Yes. We conduct internal audits in hospitals, research centers, pharmaceutical laboratories, or biotech companies. We can perform audits both nationally and internationally.
Yes. For active ingredients of all kinds: chemical synthesis APIs or biological APIs. We also support API manufacturing laboratories in India, China, and other regions.
Yes. For manufacturing laboratories as well as warehouses and/or distributors.
Yes, anywhere in the world.
Yes. We specialize in generating validation protocols for highly innovative analytical methods not covered by the European Pharmacopoeia or USP.
Yes. We can design, develop, and even provide support in implementing the CCS plan for pharmaceutical laboratories, biotech companies, and even hospitals manufacturing advanced therapy medicines: cell therapy, tissue engineering, and gene therapy.
Yes. For both non-clinical laboratories and analysis laboratories.
Yes. Both nationally and internationally.
Yes. For MDR and IVDR medical devices. We also have experience implementing ISO 13485 for software manufacturers.
Yes. For both MDR and IVDR.
Yes. Both nationally and internationally.
Yes. For both large companies and small or family-owned businesses.
Yes. For both commercial products and research phase products.
Yes, and it is tailored to each company’s specific needs.
Yes. We also offer support in license revalidation and generating both minor and major modifications.
Yes. We can even conduct follow-up audits on the implementation of the CAPA plan.
A lot. If you want us to share more details, contact us.
Monday - Friday: 9:00 - 19:00 h.
