Our Regulatory Affairs Packages
Our dedicated Regulatory Affairs Team brings decades of combined experience and insights gained across several countries to help you navigate ever changing regulatory frameworks.
Scientific advice can be sought at any stage during the product development process. Regulatory bodies offer consultations for development plans of healthcare products such as biologics, pharmaceuticals, medical devices, in-vitro medical devices, combination products and digital applications.
We can facilitate consultations on your behalf with various regulatory bodies, such as the European Medicines Agency (EMA), Food and Drug Administration (FDA), Swissmedic, Medicines and Healthcare products Regulatory Agency (MHRA), Paul Ehrlich Institute (PEI) or Federal Institute for Drugs and Medical Devices (BfArM), French National Agency for the Safety of Medicines and Health Products (ANSM).
Are you a medical device developer located within the EU? We can help you approach the appropriate Notified Body to start your regulatory journey.
Hemex offers guidance surrounding the process of seeking scientific advice and can identify the appropriate regulatory body and pathway. We also support our customers in presenting their case in a fitting manner, writing briefing documents, communicating, and setting up meetings with regulatory bodies.
SME Status Application
Companies with SME status (or Small Business Determination (SBD) in USA), could be eligible for a consultation fee discount from the regulatory bodies. We can support you throughout the application process to obtain this status. Alternatively, you can utilize HEMEX’s SME status within the EU.
The Hemex team are well-versed in dealing with regulatory affairs aspects on a national and international level. Our team has a proven track record in compiling and submitting successful Market Access Authorizations in line with regulatory requirements. We’re experienced in working with products in diverse therapeutic areas and managing entire processes seamlessly, supporting our customers throughout the development and post-market phase across drug categories like biopharmaceuticals, medicinal products (small chemical molecules), advanced therapy medicinal products (ATMPs), radiopharmaceuticals, and combination products.
We support with compliant dossier compilation, multinational submissions and filing throughout the lifecycle of a product. Our experienced team works around the clock to facilitate real-time readiness across all time-zones for a quick turnaround time. We develop and compile high-quality submission-ready documents in a secure electronic platform.
You can pick a stand-alone service from our regulatory offering or a combination of services; we can even combine our regulatory packages with our QMS offers and create a customized sweeping package!
- We assist in designing suitable regulatory strategies and provide input into non-clinical, clinical and CMC strategies for product registration.
- Take on the responsibilities of Qualified Person (QP)
- Preparation and submission of IMPDs / CTAs
- Submission and follow up of Pediatric Investigation Plans (PIPs) following an EMA timetable.
- Preparation and submission of MAAs in e-CTD format
- LOQ Management (Prepare answers to questions from authorities).
- Management of Health Authority interactions.
- Batch release of commercial products in EU following approval.
- Management of documentation for renewals, variations.
We can help you design a suitable regulatory strategy and provide input into non-clinical, clinical and CMC strategies for product registration.
- Preparation and submission of Investigational New Drug (IND), including:
- Form 1571 (IND application cover)
- Form 1572 (Investigator’s statement)
- Form 3674 (Certification requirements & mandatory registration and reporting of results for applicable clinical trials)
- Interacting with the FDA
- Preparation and submission in e-CTD format, according to the requirements of New Drug Application (NDA) / Abbreviated New Drug Application (ANDA) / Over-the-Counter Drugs (OTC) / Biologic License Application (BLA) procedures.
- Management of Requests of Information/Deficiency Letters (RFI/DL) (Prepare answers to questions from authorities)
- Management of documentation for annual reports and change evaluation.
Our extensive global network of regulatory experts specialises in bringing a variety of compliant pharmaceuticals and biologics to the global market. We continually expand our reach through our network, often supporting our clients through approval processes with PMDA (Japan), Anvisa (Brazil), TGA (Australia), Taiwan FDA, NMPA (China), and Health Canada.
Thanks to our extensive regulatory affairs experience in the international MedTech space, we can guide you through the pre-and post-market introduction phases. Successfully accessing a market requires medical device manufacturers to understand market dynamics and requirements, assessment criteria, and most importantly, associated stakeholders.
Regulatory strategies can profoundly influence timelines, milestones, budget, and development cycles of a product. We understand how important well-planned regulatory strategies for companies with medical devices in the pipeline are. Our team specialises in establishing and executing tailored regulatory strategy. We’re up to date with regulatory changes across the globe so that our clients can make informed decisions about their products.
Choose a stand-alone service from our regulatory offering or a combination of services; we can even combine our regulatory packages with our QMS offers to create a customized sweeping package tailored specifically to your requirements!
Good to know!
When developing a device, external verification testing must be carried out in accordance with regulatory requirements. Different types of accreditations exist, some open doors to any market. We partner with several excellent labs, that offer high quality testing services, competitive pricing, and efficient timing!
The introduction of MDR and IVDR was possibly the greatest change in European Medical Devices regulatory environment. We´re committed to realizing a regulatory strategy that helps you attain a CE Mark. We help our customers prioritize potential key markets within the EU.
We can assist with the following:
- Hemex can represent companies based out of the EU – authorized representative
- You can designate Hemex as your Person Responsible for Regulatory Compliance (PRRC)
- Hemex can help you define the intended device use and classify it accordingly
Formulate a CE marking strategy, customized for the device type and the target markets:
- Identification of Notified Bodies and communication.
- Identification of applicable regulations in targeted markets.
- Identification of applicable harmonized standards within the EU.
- Identification of additional requirements, for instance, external testing, QMS.
- Identification of verification and validation activities.
- Build up QMS, support with its implementation.
- Define clinical investigations/ performance evaluation plan.
- check out our CRO product)
Prior to accessing the American market, all medical device manufacturers based outside of the US, must notify and register with the FDA – Establishment Registration. Through our subsidiary in the USA, you can appoint us to represent you as FDA Agent. Additionally, our experienced regulatory team can support you with:
- Product Classification, identifying similar products.
- Small Business Determination Applications.
- Premarket Review
- Medical Listing (21 CFR Part 807)
- 510K product submission and certification:
- Strategy definition.
- Drafting main document for the 510k and review of the attachments (by the customer)
- Support in Non-conformity (NC) resolution.
- Support for compiling the initial CDRH report.
- Device listing support.
Support in the preparation and review of quality system documentation (QMS) in accordance with American regulatory requirements, including compliance with MD-SAP requirements.
We save your company time by following expedite pathways that most companies are unaware of.
INMETRO Service (Requirement for any electrical medical equipment):
- Contact with certification body (OCP) to obtain INMETRO certification for medical devices.
- Support in the exchange of documentation with the OCP, offering clarifications about the required drafting of documents.
- Support in NC resolution.
Contact with Brazilian Registration Holder (BRH) to obtain Anvisa certification of medical devices.
QMS: Support in the preparation and review of quality system documentation (QMS) in accordance with Brazilian regulatory requirements, including compliance with MD-SAP requirements.
- TFDA Product Certification:
Contact with Taiwan Registration Holder (TRH) to obtain TFDA certification of medical devices.
Support in the exchange of documentation with TRH, offering clarification when required.
Support in NC resolution.
Support in the preparation and review of quality system documentation (QMS) in accordance with Taiwanese regulatory requirements.
KFDA Product Certification:
- Contact with In Country Caretaker (ICCT) to obtain KFDA certification for medical devices.
- Support in the exchange of documentation with ICCT, offering clarifications regarding the necessary documentation and drafting processes.
- Support in NC resolution.
Support in the preparation and review of Quality Management System (QMS) documentation in accordance with Korean regulatory requirements.
Obtaining Japanese market approval needn´t be expensive and time consuming. HEMEX can assist with:
PMDA Product Certification:
- Contact with Marketing Authorization Holder (MAH) to obtain PMDA certification of medical devices.
- Support in the exchange of documentation with the MAH, offering clarifications about the necessary documentation and offering advice in the drafting of the same.
Support in NC resolution.
- Support in the preparation and review of quality system documentation (QMS) in accordance with Japanese regulatory requirements, including compliance with MD-SAP requirements.
Post-Market Regulatory Affairs
After a product has been launched and changes need to be made, feedback is collated, and market data is gathered. Regulatory Affairs plays a vital role in sustainable product and market share growth. As your Regulatory Affairs expert, we take on the task of continuously monitoring regulations, standards, guidelines as well as clarifying notifications to authorities and supporting product changes and updates to maintain the technical file.
Regulations, standards, and guidelines are the basis of product development and compliance. However, regulations, standards and guidelines continuously change and are hard to track. On average, seven standards change over the course of a weekend; thus, the world is a different one on Monday morning, not including the many published guidelines and new or updated regulations.
Notifications and Authority interaction
Unsure how to best notify your distributor, importer, EC REP or users and healthcare professionals? HEMEX can support and take on the notifications to effectively communicate with your supply chain and customers on important information and updates.
Liaising with the Authorities, both Notified Bodies and Competent Authorities require diligence and specific language. We master your interaction with the Authorities and support before, during and after audits from a Regulatory Affairs point of view.
Changes, Non-Conformities, PSUR
Continuous improvement is not only key for success but demanded by regulations for your products. We support as your Regulatory Affairs experts in assessing changes, non-conformities and updates on the product, processes, and document as well as regular reporting to the authorities in compiling the PSURs and similar documents. Specifically, we support in:
- Assessing regulatory impact change
- Assessing non-conformities for Authority reporting
- Report to and liaise with Authorities
- Assess updates to products, processes, and procedures in view of regulatory compliance.
- Compile reporting to Authorities like Notified Bodies, EU competent authorities, FDA, e.g. PSUR
- Support in field safety actions and Adverse Event reporting
- Support in EUDAMED reporting