Regulatory Operations

Regulatory Submissions & Applications

Helping sponsors to complete fast and accurate Regulatory Submissions to Global Regulatory Bodies at every stage of the Product Lifecycle.

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Regulatory Operations

Regulatory Submissions & Applications

Helping sponsors to complete fast and accurate Regulatory Submissions to Global Regulatory Bodies at every stage of the Product Lifecycle.

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.

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
Canada	Medical Device Licence Application	Classes II, III & IV	Health Canada
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