Strategic Input for Product Development
Whatever your product, no pharmaceutical regulatory affairs consultancy knows the CMC process better than Aariya.
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Strategic Input for Product Development
Involving a regulatory expert early in the product development process facilitates definition and execution of the development pathway while considering both regulatory requirements and the company’s business needs. AARIYA has extensive experience of helping cross-functional teams in:
- Strategic input through-out product development phase, be it:
- Setting of QTPP
- Identification of CQAs/ CMAs and Risk Assessment
- Formulation and Process Optimization using DoE
- Designing of Specifications (for starting materials, drug substance, inactive ingredients, packaging materials, in-process intermediates and finished product)
- Pilot bio-studies
- Technology Transfer
- Scale-up establishing Design space
- Exhibit batches
- Review of pharmaceutical development and Scale-up reports based on Quality by Design (QbD) requirements and ICH Q8 standards
- Review of all submission batch documents, like photo-stability protocol/ report, hold time study protocol/ report, manufacturing summary, process validation protocol/ report, method validation/ transfer protocol, thermal cycling and thermal excursion study protocol/ report, dilution and microbial dilution study protocol/ report (in case of sterile products), stability protocol/ data, manufacturing batch record, packaging batch record, etc.
Vision
To become a noble regulatory consultancy, delivering high quality regulatory support to clients for introduction of wide range of generic and branded products in the market.
Mission
We thrive to provide quality focused and flexible services to the utmost satisfaction of our clients building long-term relationship.
