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Research on: Risk assessment of nitrosamines in active substances and finished medicinal products.

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.

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