Pharmaceutical development
Product development
DADA has developed or has actively participated in the development of more than 50 generic or generic ‘plus’ products. These concern human as well as veterinary medicinal products. Although DADA has no private
laboratory facilities for product development, production or analysis, we manage and monitor complete product development projects, selecting the most suitable active pharmaceutical ingredient, product development company, laboratory and production facility, and CRO for clinical studies. Of course, these procedures are fully transparent and our clients always take the final decisions. It should be emphasized that DADA has no financial interest in any of these companies, ensuring a fully objective recommendation.
European Drug Master Files
In order to select appropriate active pharmaceutical ingredients, DADA has assessed the quality of hundreds of Drug Master Files (DMFs) over the years. DADA not only has assessed but also written a large number of European DMFs and related expert reports, based on the information provided by the active pharmaceutical ingredient manufacturer.
Certification of Suitability EP
If an active pharmaceutical ingredient has an EP monograph, it is possible to apply for a Certification of Suitability EP. DADA has been involved a large number of CEP certification procedures and is able to monitor the complete procedure on behalf of and in cooperation with our client.
Impurity profiling
In recent years, profiling the impurities of an active pharmaceutical ingredient and finished medicinal product has become increasingly important and is now a major issue that can prevent the granting of a marketing authorisation or the certification of EP suitability. DADA is specialized in evaluating impurity profiles and has successfully helped many companies solve problems related to the impurity profile of their active pharmaceutical ingredient or finished medicinal product.
Selection of CROs and monitoring of BA/BE studies
DADA can help you choose the best CRO for every clinical project, after which it will monitor the complete project for you. This means that we assess the study protocol before start of the project, a DADA representative will be present at the clinical trial (BA/BE study) and DADA will check the final study report. DADA is very experienced in selecting the most appropriate CRO to conduct bioequivalence testing. DADA can also arrange for clinical quality assurance inspections or audits of a CRO or site.
Interpretation of BA/BE studies
DADA has supervised or monitored close to a 100 complete BA/BE projects and has evaluated many more bioequivalence studies conducted by other companies. Thus DADA has acquired a vast body of knowledge about this very specific subject. DADA has demonstrated that it is not only able to adequately monitor bioequivalence studies; it is also able to find creative solutions for non-standard problem situations.
QA/QC Advice
DADA manages and performs all sorts of QA/QC projects, if necessary in close cooperation with external experts, for example auditing manufacturing sites of toll manufacturers or active pharmaceutical ingredient manufacturers. DADA communicates with various toll manufacturers on behalf of our clients in order to assure optimal product quality in accordance with the approved marketing authorisation files. DADA also supports pharmaceutical companies that are transferring the production of their products to manufacturing locations outside the EU.
Emerging markets manufacturer third party GMP auditing
Conduct of proper GMP audits at Chinese, Indian or other Asian API and finished product manufacturing sites is often complicated by communication problems and unclear situations. It is therefore considered essential to use well-trained local GMP auditors for the conduct of these audits.
Bearing this in mind DADA Consultancy has established a relationship with a number of local GMP experts that have extensive experience in quality assurance and quality control at EU/US quality levels and that are available for the conduct of GMP audits according current GMP guidelines ICH Q7, EU-GMP. Therefore DADA Consultancy is now able to offer GMP audits of Chinese, Indian or other Asian API and finished product manufacturers.