Registration of pharmaceutical products with Health Canada through the Abbreviated New Drug Submission (ANDS) application might have similar technical requirements to that of the United States Food and Drug Administration (US FDA) and the European Medicines Agency (EMA). This simplifies the Canadian registration process for medicinal products which are already registered with the U.S. and the EU Health Authorities. However, to understand Health Canada’s unique procedural and technical requirements like, Drug Establishment License (DEL), it is vital to consult a Regulatory expert for quicker registration and approvals.
Freyr has prior experience and expertise in handling generic application (ANDS) submissions with Health Canada for all kinds of dosage forms of pharmaceutical products. Freyr plays a key role in streamlining the registration and approval procedures and is capable of:
- Regulatory submission road map/filing procedure for ANDS and supporting document generation.
- Regulatory consultation during product development & manufacturing phase for selection of RLD/Reference Standard, review of specifications for finished product/in-process controls/API, Product Development Report, process validation protocol/report, stability study, and guidance on batch size requirements.
- Preparation/review of the ANDS Health Canada submission strategy and guidance on risk mitigation plans.
- Handling pre-submission meetings with Health Canada.
- Support for DEL application submission.
- Providing ANDS documents checklist.
- Gap-analysis/Regulatory assessment of generated source data for Regulatory adequacy.
- Guidance on the generation of additional/missing documents.
- Preparing Abbreviated New Drug Submission package in line with the current Health Canada requirements.
- Publishing and submission of the ANDS in the eCTD format.
- Interaction/follow-ups with Health Canada for the ANDS approval.
- Regulatory strategy and response preparation for HC queries for quicker approvals.