Pharmaceutical Regulatory Services
We help your product regulatory strategy and process to gain faster approvals and ultimately help patients. With industry-leading knowledge and skills, we can provide regulatory support for gaining approval: for the first in human trials, during development, and scientific advice, at the end of phase 2, phase 3, and post-approval. At every level, our scientific expertise and in-depth knowledge of therapeutic backgrounds help clients to a successful outcome.
Navigating Pharmaceutical Regulations with Expertise
1. Pharmsky has global regulatory expertise to navigate and cater to the Region/country-specific regulatory requirements for handling product development, Analytical method development, Analytical method validation, setting up specifications, technology transfer, manufacturing, process validation, batch analysis and stability testing, and deriving shelflife of the product.
2. Subject Matter Expertise (SME) for risk assessment of extractables and leachables and nitrosamines as per ICH M7 and ICHQ3D.
Regulatory Strategy and Consulting
1. Pharmsky provides Regulatory Strategy by reviewing the CMC documentation of Product development, manufacturing, and analytical methods and data to minimise the impact on product safety and quality which directly impacts the cost of regulatory submissions for life cycle management. Quality and regulatory review of development records, technology transfer records, master/executed batch records, specifications, test methods, validation and stability protocols, and reports for adequacy and accuracy.
2. We provide support for regulatory change management during the lifecycle of the product to address the challenges with changes to approved manufacturing processes, specifications, test methods, and storage conditions.
3. Timely Support for addressing CMC and related regulatory deficiencies on DMF, Dossiers, abbreviated new drug application (ANDA), IND, and NDA filings to get faster approvals.
Types of Regulatory Services Offered
Pre-Approval Services
Module-3 CMC data compilation of drug substances and products. CMC data compilation covers all the contents of the product development, manufacturing, and quality data. Expert review of drug master files (DMF), Dossiers, investigational new drugs (IND), and new drug applications (NDA) and provide Gap Analysis and support to mitigate the gaps to minimize the regulatory deficiencies and get the right first time for faster regulatory approvals.
Post-Approval Services
Point 2 and 3 of Regulatory strategy and consulting Region and country-specific Regulatory CMC documentation Subject Matter Expertise (SME) for risk assessment of extractables and leachables and nitrosamines testing as per ICH M7 and ICHQ3D.
Why Choose PharmSky To Partner With?
Pharmsky has global expertise andregulatory experience in handling end to end product lifecycle from development to commercializtion of the product.
Contact Us Today
Fast track your development with our extensive services. Get in touch so we can discuss your requirements.
