REGULATORY SUBMISSION
We at Atili Pharma help you process and submit the information about your newly developed healthcare product to a regulatory agency for a review. We gaurantee successful submission and work. Your Business is our Responsibility.
What We Help With!
Electronic Common Technical Documents
The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research…
Dossier Review and Readiness
Assessment of product dossiers is conducted in accordance with standard operating procedures that ensure uniformity in evaluation and time…
Post Approval Support/ Submission Review
Review and submission of supplement/amendment for change in manufacturing site, batch size or formulation, route of synthesis…
Review and Assessment Submitted
Assessment is generally a continuous and formal process of evaluating, measuring and documenting educational effectiveness.
oUR SERVICES BASED ON REGULATORY STANDARD
- Drug and Cosmetic art
- World Health Organization(WHO)
- Food and Drug Administration(USFDA)
- Health Canada
- EU/EMA
- Pharmaceutical Inspection PIC/S
- Therapeutic Goods Administration(TGA)
- Pharmacopoeias(IP/BP/EP/USP)
More Services
- ICH
- Parenteral Drug Assosiation
- Japan - MHLW
- Brazil - ANVISA
- Rest of World Regulatory
OUR FOUNDATION: Ability & Re-Imagine
We have the ability to move back and forth between looking at the larger micro/macro issues as well as the every day operational needs. We do understand your corporate perspective as well as your challenges. We are ultimately problem solvers and bring our breadth of experience and insight when meeting your business needs. We know what a Business wants. We deliver in a professional manner. No matter how far you are, we’ll help you with ease. Saving your time is our mission. Experience Fast Service. Then why wait? Let’s grab our services now!