DADA Consultancy is a highly specialised and independent consultancy agency in international regulatory affairs of human and veterinary medicinal products. We can provide tailor-made services completely in line with your needs. DADA can find optimal solutions for your requirements and is therefore an ideal partner for supporting and managing your European regulatory activities. We have a passion for detail while maintaining focus on our client’s ultimate goal. We often solve uncommon problems with uncommon approaches, unlocking your data’s full potential. If you are stuck with an issue that seems unsolvable, or are in need for unlisted services, we invite you to contact us. We will give our utmost in helping you out, and in the unlucky chance that we cannot, we will still help you further and find the expert who can.
As our services below describe in more detail, DADA can help you from start of development until the end of the products lifecycle, and everywhere in between.
Our services encompasses a wide range in the fields of pharmaceutical development, regulatory affairs, pharmacovigilance, quality assurance, clinical and non-clinical activities including medical & scientific writing, market access and reimbursement. Together with our sister company ADOH, we can also offer EU batch release service, and GxP auditing.
DADA has experts on staff who advise on or assist with multiple aspects of the product development. Selection of the appropriate active pharmaceutical ingredients, applying for a Certification of Suitability to the monograph of the European Pharmacopoeia (CEP), writing Drug Master Files (DMFs) or evaluating impurity profiles and solving potential problems related to the impurity profile are all part of our portfolio. Our experts can assist in troubleshooting problems with the quality of your product. We can help you to identify the root cause of the problem (e.g. formulation, manufacturing, packaging, or control) and find a creative solution to the problem. DADA can manage and perform all sorts of Quality Control (QC) projects, and can offer GMP audits of Chinese, Indian or other Asian API and finished product manufacturers using a number of local GMP experts.
For more information on our pharmaceutical development services, visit our website or contact us via email.
DADA’s Regulatory Affairs (RA) department is available for all sorts of questions. Whether you wish to establish your own regulatory department on site and seek advice, or whether you require DADA to function as a virtual private regulatory affairs department of your company, we are available in any case. From the moment of determining the best regulatory strategy for your product, including performing feasibility studies, DADA can be involved and provide support. By writing the Marketing authorization (MA) dossier and performing the MA application, maintaining the dossier throughout the whole lifecycle, and withdrawing the MA when required, DADA can support with the whole lifecycle, regardless of the RMS of number of CMSs involved in the procedure.
For more information on our regulatory services, read the information on our website or contact us via email.
A marketing authorisation may only be granted to an applicant established in the European Community. Via DADA’s sister-company ADOH, we can act as the formal marketing authorisation holder for your medicinal product marketing authorisations in any EU/EEA country. This service is offered to any clients from outside the EU/EEA who do not wish to establish a European affiliate. It also offers the possibility to European companies to develop their business discreetly.
For more information on our MAH service, read the information on our website or contact us via email.
DADA has an extensive network in place to ensure a successful market access to make innovative and meaningful products available to patients. DADA can help to arrange that all national requirements are being met in order for the product to be ready for commercialization. Whether these are markets that DADA has available in-house or not, via our extensive network we can cover all EU/EEA countries. Examples include national portals to announce commercial availability, requesting national numbers from authorities, or managing the pricing and reimbursement applications.
For more information on our Market Access services, read the information on our website or contact us via email.
DADA provides support with multiple kinds of clinical and non-clinical activities. This includes writing state-of-the-art expert reports, clinical and non-clinical overviews for inclusion in the registration dossier, advice on clinical strategy suitable for each type of clinical study, designing the clinical study, and providing advice on bioequivalence studies and non-inferiority or superiority efficacy trials for both human and veterinary products. Additionally, DADA can assist in the development of a Post-Authorisation Safety study (PASS) and take a leading role in the PASS protocol preparation and conduct. We can write the clinical trial documents, e.g. protocols, help you choose suitable CRO for clinical studies phase I-IV, and manage the studies for you. For safety management during clinical trials, see our PV services.
For more information, visit our website or contact us
More Information » www.dada.nl/pharma-s-e
DADA is capable of supporting with all aspects of Quality Assurance Compliance. Our quality experts can support with the application for registrations (e.g. MIA, WDA) and licenses (e.g. for controlled drugs), and assist in setting up the required quality system. We are also available to perform on your behalf or assist you with different types of audits and inspections. Examples include assisting your company during the inspection by the Dutch Healthcare Inspectorate, or performing a (pre-)inspection of your production facilities to prepare it for an inspection of EU healthcare authorities or a customer audit. DADA can of course always be on stand-by during and after the inspection or audit, to help to correct any findings and non-conformities.
For more information on our QA services, visit our website or contact us via email.
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DADA's pharmacovigilance (PV) department is comprised of physicians and life science professionals with extensive expertise, providing full PV services for a wide range of human and veterinary medicinal products. We can support you with safety monitoring throughout the product's life cycle and implement (local) requirements as and when needed in the EEA. DADA has available a network of qualified local QPPV partners in a significant number of EEA countries, which we will use when you need advice and support in establishment of your local QPPV network.
We can provide a large number of vigilance services for our clients. Our PV services include literature screening, ICSR processing, writing of reports (e.g. RMP's, PSURs), maintaining the XEVMPD, signal detection, and many more. In addition, we have a team who ensures all activities are auditable and compliant. For the full scope visit our website or
More Information » www.dada.nl/pharmacovigilance
Advertising of pharmaceutical products is regulated on an EU member state level, and ensuring compliance therefore requires specific expertise. DADA is an established service provider in the field of pharmaceutical advertising and financial relations. Our dedicated and qualified team ensures your pharmaceutical advertising and financial relations are compliant, with practical solutions to get there. This includes review of written and oral promotion, patient support programmes and financial inducements. DADA can also offer tailored compliance trainings for employees involved in advertising.
For more information on our advertising compliance services, read the information on our website or contact us via email.
DADA can, via our sister-company ADOH, perform the import and EU batch release for your human or veterinary medicinal products. We are licensed to perform the EU batch release and import of sterile and non-sterile medicinal products, sterile and non-sterile investigational medicinal products (IMPs), biological IMPs (cell therapy and “others”), and veterinary sterile and non-sterile medicinal products. Via our network of subcontractors, we can take care of analytical and microbial testing of samples, and arrange the distribution of your medicinal product throughout Europe.
For more information on our batch release services, read the information on our website or contact us via email.
Using our vast network of experts, DADA can, either directly or via our sister-company ADOH, assist in the auditing efforts required to ensure a proper supply chain. We can audit active pharmaceutical ingredient manufacturers, finished dosage form manufacturers, analytical laboratories and wholesale dealers on your behalf, and perform a pre-inspection of your production facilities in order to prepare it for an inspection of EU healthcare authorities. Our experts can be available during the inspection (or customer audit) as well after the inspection/audit to help to correct any findings and non-conformities. We have substantial experience in supporting non-EU companies in preparation to their first EU GMP inspections.
For more information on our GxP services, read the information on our website or contact us via email.
More Information » www.adoh.nl/gmp-glp-gdp-auditing-service
