Consulting support for GMP projects and audits
Our GMP consultants are pleased to support your GMP projects.
Consulting, training, conceptual design and active project management with regard to GMP and ISO compliance, the planning and implementation of a new construction and a conversion as well as qualification and validation projects in the pharmaceutical, biotechnological and medical device manufacturing industries, are likewise in their focus.
Our GMP experts support the entire spectrum from major customers to start-ups across all industries.
All our senior consultants also act as auditors with different focal points. According to their qualification and certification they offer audits in the areas of GMP, API and EN ISO 9001 and 13485.
In the GMP-regulated industry, experience and expertise are fundamental and a prerequisite for a pragmatic and efficient consulting service. Therefore, project support should take into account both economic aspects and GMP-relevant requirements. Our senior consultants are professionals with more than 20 years industrial experiences in different roles.
Use the competence of our GMP consultants to efficiently implement your compliance project or to be prepared for upcoming audits.
Here you can get an overview about our entire GMP consulting services and Audit & inspection service portfolio.
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Brochures
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QM documents
- Researches
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References
Valicare has got a lot of references through the longterm project work
Since founding in 2002, the Valicare GmbH has carried out more than 2.000 successful ISO and GMP compliance projects with international (bio) pharmaceutical key accounts and manufacturers of medical products.
Our focus is on consulting, risk and quality management, audits and inspections, as well as the risk-based qualification and validation of pharmaceutical, mainly aseptic filling lines, and processes.
Over the last years, we have developed a special focus on the support of customers in the development and manufacture of novel medicinal products and investigational drugs, so-called ATMPs (advanced therapeutic medical products).
Our teams have gained a great deal of experience in the efficient handling of complex customer-specific projects in the pharmaceutical, biotechnological and medical device industries and established a loyal customer base.
With pleasure we set up a references list, referring to your planned project.
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Relevant ATMP Links
Here you get a first overview about the relevant regulatory requirements, regulations, laws as well as competent authorities and organisations in Germany, Europe and US, that are important for ATMPs.
Germany
- PEI, overview of ATMPs
- EPI, ATMP vigilance
- PEI, clinical trials
- PEI, marketing authorisation of human medicinal products
- PEI, approval according to §4b AMG
- German drug and active ingredient manufacturing regulation (AMG)
- §4b Special provisions for advanced therapy medicinal products
EU- EMA, overview of ATMPs
- EMA, legal framework for ATMPs
- EMA, meetings with stakeholders and other organisations
- EMA, support for ATMP developers
- EMA, certification procedure for micro, small and medium-sized enterprises (SMEs)
- EMA, relevant guidelines for ATMPs
- EMA, ATMP classification
- EMA, summaries of scientific recommendations on ATMP classification
- EMA, marketing authorisation for ATMPs
- EMA, pharmacovigilance for ATMPs
- EMA, committee for advanced therapies (CAT)
- European Commission, overview of ATMPs
- EU GMP Guideline
- Guidelines on good manufacturing practice specific to advanced therapy medicinal products
- Guidelines on good clinical practice specific to advanced therapy medicinal products
USA- FDA, overview of cellular and gene therapy products
- FDA, guidances to cellular and gene therapy
- FDA, framework for the regulation of regenerative medicine products
- FDA, guidance for industry - potency tests for cellular and gene therapy products
- FDA, guidance for industry - preclinical assessment of investigational cellular and gene therapy products
- FDA, guidance for industry - considerations for the design of early-phase clinical trials of cellular and gene therapy products
- 21 CFR 1271 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
We are there for you
Contact us if you have any questions. We will gladly answer and advise you.