Regulatory Submissions & Applications
Regulatory submissions and applications play a crucial role in the pharmaceutical industry, as they are used to obtain approval for the marketing and sale of new drugs and treatments. Keeping up to date with regulatory changes and updates is critical to ensuring that the submission and application process meets the latest requirements.
Regulatory submissions and applications in the pharmaceutical industry are critical processes that require specialized knowledge and expertise.
- Extensive knowledge of Agency regulations, guidance and expectations built on first-hand experience
- Clinical trial applications
- Requests for orphan drug or fast-track designations
- Applying latest methods in scientific research
- Leveraging latest technology for content creation
- Always meeting timelines and avoiding delays
Our Regulatory Submission & Application Services
Regulatory submissions and applications for the pharmaceutical industry are complex processes that require a high level of expertise and attention to detail. Our team has the expertise to deliver the following services around regulatory submission and application process drugs, biologics and medical devices.
For Drugs and Biologics
Our team has the expertise to prepare and complete the following submissions using the Electronic Common Technical Document (eCTD) standard.
> New Drug Application (NDA)
> Abbreviated New Drug Application (ANDA)
> Investigational New Drug Application (IND)
> Biologics License Aplication (BLA)
> Master files: Drug Master File (DMF) and Biologics Master File (BMF)
> Emergency Use Authorization (EUA)
For Medical Devices
We can assist with the following Regulatory Submissions for different medical device classes as mandated by the respective regulatory body.
| Jurisdiction | Regulatory Submission | Device classification | Regulatory body |
| Canada | Establishment registration (MDEL) | Class I & all importers or distributors of all four device classes to permit importation or distribution (sale) of a medical device in Canada1 | Health Canada |
| Medical Device Licence Application | Classes II, III & IV | ||
| US | Establishment registration | Classes I, II & III | U.S. Food and Drug Administration (FDA) |
| Traditional, abbreviated or special 510(k)s | Class I, II, and III (where PMA is not required) |
● FDA OR ● Accredited party + FDA (for products eligible for third-party review) |
|
| De novo | Low- to moderate-risk devices that have been classified as class III because they were found not substantially equivalent to existing devices | FDA | |
| PMA/PDP* | Class III & high-risk devices that are non-substantially equivalent (NSE) to class I, II or III (device may be eligible for de novo)2 | FDA | |
| EU | Technical documentation |
Class I Exceptions: Class Is*, Im*, Ir* |
Self-certification by manufacturer |
| Technical file | Class Im, Is, Ir, IIa, IIb, III | Notified Body | |
| Design dossier | Class III | Notified Body | |
| Consultation dossier (only for the medicinal ingredient used in the device) |
Class III (a device with a medicinal ingredient) and Class IIa and IIb if they compose of substances or a combination of substances to be introduced to the body
|
Competent Authority or European Medicines Agency (EMA) coordinated via the Notified Body |