MEDVACON provides a host of Regulatory Compliance consulting Services. Our Regulatory experts possess comprehensive knowledge of the Code of Federal Regulations and are prepared to assist you with your Regulatory Compliance Consulting needs. Our experience provides us with a unique understanding of the impact of federal regulations on your business operations. Our experts can provide in-depth assessments of your company’s compliance levels and help get products to market quickly.
MEDVACON offers a comprehensive menu of cost-effective solutions and helps our clients traverse the landscape of regulatory requirements and language and to mitigate the risks associated with operating in a regulated industry.
Investigating the cause of a quality failure or other production problem is something that all pharmaceutical companies must do, some more frequently than others. The more comprehensive and structured the investigation process is, the more effective it will be. While CAPA is handled differently at many pharmaceutical manufacturers, best practices for handling complaints and investigations revolve around certain core activities, a basic process and, more often than not, some enabling technology. MEDVACON's Team of Quality Investigation and CAPA experts can assist your company in achieving Quality Investigation compliance.
The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, sets forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU. The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is impacting the IVD industry at all levels.. Under this directive, all products, regardless of class, that stay on the market following the transition date of May 26, 2022 must be reassessed for IVDR compliance to ensure that products are fit for purpose and safe for use.
Starting May 26, 2022 new devices will have to meet the requirements of the IVDR in order to be placed in the European market. Products already certified by a Notified Body may be placed on the market until 25 May 2024 under some conditions and if the manufacturer fulfill the specific prerequisite requirements drawn in the IVDR.
The biggest change from IVDD to IVDR is the introduction of a risk-based approach to classification in addition to increased NB oversight. The Regulation identifies four new risk classes: Class A (lowest risk), Class B, Class C, and Class D (highest risk) aligned with IMDRF/GHTF IVD classification guidance. Under the current regulations, most IVDs are self-certify, thus a NB does not have to review the technical file. There are very few delays. With IVDR most IVD will not be self-certified and instead will fall into Class B, C, and D IVDs which will require NB intervention as part of their conformity assessment. Technical files and clinical evaluation reports that have been used for years. Medical device companies will need to be revised to meet the new regulations. This will also increase the strain on NB resources, in addition to the extra work caused by the MDR.
Here’s a quick look at some of the key provisions included in the IVDR:
MEDVACON IVDR Transition Steps:
A client developing drug-eluting bioresorbable coronary scaffolds for the treatment of cardiovascular disease, the leading cause of death worldwide engaged MEDVACON to assist the firm in preparing a drug dossier required for CE Submission in Europe. Specifically, MEDVACON's scope of services was to: Review program and current status; Review requirements for a drug module going to MHRA; Organize communication and next steps; Set initial assignments and requirements for a given section; Update work remaining and subsequent planning; Upon completion of the module provide final review and comments to client team.
MEDVACON's client is a pharmaceutical company whose mission is not one of drug discovery but rather that of acquisition and commercialization of prescription products that will satisfy unmet clinical needs in specialty therapeutic areas. This “virtual company” outsources the manufacture, pharmaceutical development, packaging and testing of their products. MEDVACON was enlisted to provide Regulatory Compliance assistance to support the development of Annual Reports for submission to the client's eCTD submission vendor. Specifically MEDVACON reviewed submission documents and prior Annual Reports to assemble the submission materials and prepare the submission form.
A biopharmaceutical company specializing in applying deuterium chemistry to known molecules to create novel therapies with the potential for improved safety and efficacy profiles engaged MEDVACON in the area of Regulatory Compliance Consulting. Client enlisted MEDVACON to assist in bringing their product from development to market. Specifically MEDVACON provided assistance with ensuring regulatory requirements were addressed and specifically ensure all elements of the CMC section were accurately represented. The product received FDA approval and MEDVACON remains engaged overseeing CMC and Clinical Supply activities.
MEDVACON's client is a combination Pharmaceutical- Medical Device manufacturer engaged in emergency care treatment options into the hands of military and civilian defenders for more than 50 years. Our client is committed to help defend against critical, time-sensitive, life-or-death situations by providing medical countermeasures to the United States Department of Defense, Emergency Medical Services, Homeland Security, and more than 30 nations around the world. Client engaged MEDVACON to assist in Root Cause Analysis and remediation of FDA findings.
A combination Pharmaceutical-Medical Device manufacturer engaged in emergency care treatment options into the hands of military and civilian defenders engaged MEDVACON to provide R&D support services for the development of new products as well as the improvement of existing auto-injector design.