iCretegy Expert team provide excellent support to provide creative strategy, review ANDAs/NDA/505b(2) application that move pharmaceutical companies and other client types to the desired outcome more quickly and efficiently.
iCretegy services enable Life Sciences, Consumer Pharma and Bio-Med companies to understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully launch their products in new markets and maximize their market value.
The Regulatory Affairs Practice Services and Features:
- From product development to expert review of the submission, pre-submission to filing the original application (eCTD or CTD) ANDAs/ NDAs (505(b)(2)/ DMFs (Type II, III, IV) to regulatory agencies, amendment (handling of regulatory Agency’s deficiency strategies and preparation of response packages) to life cycle management (post approval change supplement/ variations), PADERs to Annual Reports/Renewals.
- Product Feasibility Evaluation, Gap Analysis, Product Development (Keep launch in mind and on-time), and support with risk mitigation
- Regulatory Submission Strategy Begin with End in Mind, which accelerate the approval time with minimum deficiencies
- Provide Regulatory Tools which enable you to smooth approval, Remediation of Regulatory Deficiencies & resolutions for faster market penetration.
- Designing specifications as well as providing guidance in the preparation of protocols/reports for product development, process validation, exhibit batches, hold time studies, and stability studies.
- Working with Regulatory Agencies for strategic help and support for quick resolution
- Perform due diligence audits of applications in association
- End to End service for Company or Product (In license & Out license) M&A
- Expertise in providing post-approval regulatory strategy for $Synergy supplements like,
- removal of test from In-process /FP/API/PM Specification by providing supporting justification,
- reduce testing program for API, FP, Excipient, and Packaging Component rather than testing each lot.
- Limit the test to In-process or FP release with technical justification
- Reduction in stability time points (ICH Q3D/Q3E)
- Improvement of Mfg. Process and its parameters
- Exclusion of non-critical excipient testing site
- Yield limit relaxation
- Shelf-life extension
- Work as U.S. Agents for non-U.S. companies while providing global regulatory expertise.
- Provide support with drug listing, facility registration, and guidance on meeting GDUFA requirements
iStrategy - i$Synergy - iSystem Enhancement
- Regulatory approval procedures are becoming increasingly stringent and time-consuming. Not having the right regulatory strategy and Regulatory tools in place will cost time and money, and may result in the failure or delay of your application, and acceptance and lead to Major CRs.
- Increase your program’s chance of expedited success, iCretegy team provides robust regulatory strategy, consulting, and regulatory submissions support for your application with customized iCretTools from filing, amendment, approval to life cycle management.
- We also help to provide complete planning to take the approved product from one market to another market
- We also provide services of the Simplification of all CTD Modules.
- We also conduct in-person seminars, workshops or summit for your company which will helpful for all cross-functional teams to work together for the company & customer vision including IQA, No Major CRs, GDUFA III, Introspect in Investigation, CAPA to PACA, and many more…