How can expert CRO support be utilized for regulatory affairs?
The group of scientists assigned to interact with regulative authorities for the submission of new medical products is called Regulatory Affairs. These professionals work alongside the manufactures in communicating with federal, state and local regulation agencies about specific issues regarding safety and efficacy of a new device.
The medical devices’ industry is a cornerstone of the healthcare system that offers innovative solutions to improve patient outcomes all over the world, but the road between design and commercialization can be long and complex, so the input of specialists will provide a smoother ride.
Regulatory Affairs Compliance is the key to success of your product, and for thar reason our expert Contract Reseach Organization works closely with you to prepare scientifical documentation that meet your needs, and implement a competitive and cost-effective strategy for marketing application.
The performance of Regulatory Affairs professionals
When a new technology is presented, specialists work alongside the government and businesses to ensure that the standards of product manufacturing, safety and marketing practices are met. Quality assurance and Regulatory Affairs can’t be dissociated from each other, so the functions performed by a regulative team are vital to evidence effectiveness and safety of the medical products to patience’s healthcare.
The responsibilities expected of regulatory professionals begin in the development and research stage, extending to clinical trials, premarket approval, postmarket surveillance and even labelling of the device. The most important of those responsibilities is to properly registrate a product under the country’s health agency (e.g. FDA, EMA, MDR) and get the necessary acceptance for market.
Responsibilities throughout the device’s life cycle
Premarket Regulatory Strategy: Regulatory Affairs professional advises on appropriate strategic decisions leading to market approval. To be successful, the team must have a well understanding on international regulations requirements the device will be subject to.
Marketing Applications: At this stage, the team must draft a successful marketing submission and review product labelling to ensure all claims are consistent with the approved intended use.
Postmarket Surveillance: The updating of clinical data through the implementation of a postmarketing follow-up study has become a standard activity. Is required that through the entire market life of the product the team ensures that any adverse events or malfunctions are appropriately reported to the regulation agency.
Regulatory Affairs for IVD on an international scale
Many IVD manufacturers are faced with a complex process of writing files to comply with the regulations, and depending on market targets intended for launching a medical device the regulatory requirements for the approval have different rules and laws applied in each case.
It is important that the development of your international approval strategy works in the most effective way possible, and that’s why it is essential for the team in charge of carrying for that matter to be familiar with distinct systems.
A leading regulative council must be ready to provide expert support for regulatory submissions in different countries, including EU MDR, FDA 510(k) and PMA, offering wisdom, honesty and collaboration while also ensuring client confidentiality to structuralize registration documents.
As it is a complicated pathway, to save time and money, working alongside a company that can provide such knowledges may be the bast way to navigate the process of application and communication between manufacturer and administration offices.
The role of CRO professionals
As an experienced Contract Reseach Organization, ECLEVAR MEDTECH is ready to step in and perform Regulatory Affairs activities to support your product and your documentation needs. We have more than 20 years of experience on regulation requirements and a team built with competent and knowledgeable professionals that had direct contact with regulation agencies and will work as an extension of your business.
ECLEVAR can help you in Regulatory Affairs:
- Supervise legislation in all the regions targeted for market
- Oversee legal and scientific restraints and requirements
- Colect and evaluate scientific data
- Prepare clear documentation for regulation agencies, as well as keep the authorisation for distribution
- Advise on strategic and technical matters as an outsourced resource
- Follow the product’s development stages, market concepts and packaging creation
- Keep a safety medical monitoring
Contact us to better understand administrative expectations and how to apply this Regulatory Affairs knowledge your medical device organization, whether for specific projects or all things regulatory.