The right regulatory strategy is the backbone of market access for any product and plays and equally important role both in pre- and post-market phases.

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Our Regulatory Affairs packages

Our dedicated Regulatory Affairs Team will employs years of experience and insights gained across several countries to help you navigate the constantly changing regulatory settings.

A scientific advice can be asked for at any point during the development of your product. However, seeking advice from regulatory bodies early during the development of your product makes sure that all your time and effort spent are in the right direction. A scientific advice can be especially beneficial in certain scenarios where Lucky for us, most of the regulatory bodies offer consultation on the development plan of healthcare products including biologics and pharmaceuticals, medical devices, in vitro medical devices, combination products, and digital apps.

We can support you in facilitation of consultation with various regulatory bodies, such as 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). For medical device developers in EU, we can help you in approaching the appropriate Notified Body and facilitate a conversation with.

We guide our customers through the process of seeking scientific advice by establishing a scientific advice strategy, where we identify the appropriate regulatory body and then the appropriate pathway that the regulatory body offers. We also support our customers in presenting their case in a fitting manner, writing briefing documents, communicating and setting up meetings with regulatory bodies.

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Did you know?

Companies with SME status (or Small Business Determination (SBD) in USA), often get a discount from the regulatory bodies on the consultation fee. We can also support you through application procedure of this status or you can ‘piggyback’ on HEMEX’s SME status in EU.

With several years of expertise, we are well-versed in dealing with regulatory affairs aspects at a national and international scale. Our team has a proven track record in compiling and submitting successful Market Access Authorizations in line with regulatory requirements. We have the experience of working on products in diverse therapeutic areas and managing the entire process seamlessly. We support our customers through out 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, and 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!

EU
  • We can help you design a suitable regulatory strategy and provide input into non-clinical, clinical, 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 EMA timetable.
  • Preparation and submission of MAAs in e-CTD format
  • Management of LOQs (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.
USA
  • We can help you design a suitable regulatory strategy and provide input into non-clinical, clinical, 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 requirement & mandatory registration and reporting of results for applicable clinical trials)

  • Interacting with 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, change evaluation.
Global

We have an extensive network of regulatory experts globally and together we bring varied medical devices to global markets that comply with local regulations. We continually expand our reach through this extensive network, and we often support our clients with PMDA (Japan), Anvisa (Brazil), TGA (Australia), Taiwan FDA, NMPA (China), and Health Canada.

With our extensive experience in regulatory affairs in international MedTech space, we can guide you through the pre- and post-market phases of your device. To access a market, it is essential for medical device manufacturers to understand market dynamics and requirements, assessment criteria, and most importantly, associated stakeholders.

The regulatory strategy profoundly influences timelines and milestones, budget, and development cycles of a product. Thus, we understand how important a well-planned regulatory strategy is for a company with medical devices in pipeline and we dedicatedly work with our customers to establish and execute a tailored regulatory strategy. We keep-up with the dynamics of regulatory affairs across the globe so that our clients can make informed decisions for their products.

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!

Good to know!

Surely you are aware that, when developing a device, you must conduct external verification testing according to standards in order to meet regulatory requirements. You may not know that there are different type of accreditations, and some open you the doors of any markets. We are partner of several excellent labs, that offer testing service with extremely high quality, low price and efficient timing that will surprise you!

EU

Introduction of MDR and IVDR was possibly the biggest change in European Medical Devices regulatory affairs in the recent past. We have graduated towards the end of the transition period now and are committed to realize a regulatory strategy towards a CE Mark. We help our customers prioritize the key markets within EU. How can we help you in EU?

  • We can represent the companies based out of EU – authorized representative
  • You can designate us as your Person Responsible for Regulatory Compliance (PRRC)
  • We can help you define the intended use of the device and classify it accordingly
  • Formulate CE mark strategy, customized for the device type and the target markets:

    Identification and communication with Notified Bodies.

    Identification of applicable regulations according to regulations in targeted markets.

    Identification of applicable harmonized standards in 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 investigation / performance evaluation plan.
  • Defining and establishing Technical Documentation including. Clinical/Performance Evaluation Reports (for more information check out our CRO product)
  • Supplier management and audit.
  • Compile and submit dossier to Notified Bodies.
USA

Prior to accessing the American market, all medical device manufacturers based outside of US, must notify the FDA and register with it – Establishment Registration. Through our subsidiary in USA, you can appoint us as a US FDA Agent to represent you. Additionally, our experienced regulatory team can support you with:

  • Classification of the product, identify similar product.
  • Small Business Determination Application.
  • Premarket Review.
  • Medical Listing (21 CFR Part 807)
  • 510K product submission and certification:

    Support in defining the strategy.

    Drafting of the main document of the 510k and review of the attachments (by the customer)

    Support in Non-conformity (NC) resolution.

    Support for compiling the initial CDRH report.

    Support for device listing.

  • Support in the preparation and review of quality system documentation (QMS) in accordance with American regulatory requirements, including compliance with MD-SAP requirements.
Brazil

We can let you save YEARS following expedite pathways that the most of companies are unaware of.

  • InMetro Service (it is a requirement for any electrical medical equipment):

    Contact with certification body (OCP) to obtain inmetro certification for medical devices, household appliances and electric equipment in general.

    Support in the exchange of documentation with the OCP, offering clarifications about the necessary documentation and offering advice in the drafting of docs.

    Support in NC resolution.

  • Anvisa Service:

    Contact with Brazilian Registration Holder (BRH) to obtain Anvisa certification of medical devices.

  • Support in the exchange of documentation with the OCP, offering clarifications about the necessary documentation and offering advice in the drafting of the same.
  • Support in NC resolution.
  • QMS:
    Support in the preparation and review of quality system documentation (QMS) in accordance with Brazilian regulatory requirements, including compliance with MD-SAP requirements.
Taiwan
  • 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 clarifications about the necessary documentation and offering advice in the drafting of the same.

    Support in NC resolution.

  • QMS:

    Support in the preparation and review of quality system documentation (QMS) in accordance with Taiwanese regulatory requirements.

South Korea
  • KFDA Product Certification:

    Contact with In Country Care Taker (ICCT) to obtain KFDA certification of medical devices.

    Support in the exchange of documentation with ICCT, offering clarifications about the necessary documentation and offering advice in the drafting of the same.

    Support in NC resolution.

  • QMS:

    Support in the preparation and review of quality system documentation (QMS) in accordance with Korean regulatory requirements.

Japan

Many companies think that this market approval in expensive and takes a lot of time. We are partner of a brilliant, superfast and affordable consulting company.

  • 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.
  • QMS:
    Support in the preparation and review of quality system documentation (QMS) in accordance with Japanese regulatory requirements, including compliance with MD-SAP requirements.
Global

We have an extensive network of regulatory experts globally and together we bring varied medical devices to global markets that comply with local regulations. We continually expand our reach through this extensive network, so get in touch now!