REGULATORY AFFAIRS
CMC
Product Licence Maintenance
Dossier build
Labeling
CMC
CMC
Medicinal products on the market are required to be manufactured to an appropriate quality.Dealing with the regulations and compliance sometimes complex and requirements in various countries further complicates the Chemistry, Manufacturing and Control (CMC) process.
iReg Consulting’s excellence lies in the Technical CMC expertise and deep domain experience across the entire product lifecycle for small molecules and biologicals. iReg Consulting has the scalability to manage projects of any size.
Pre Approval
Product Licence Maintenance
iReg Consulting has extensive experience in maintaining product licence activities throughout the product’s marketing lifetime. We have successfully performed following services for our clients.
- Variations (EU, US and International)
- Renewals
- Dossier reformatting – Reformatting information from old NTA Part II dossier into new CTD or ACTD format to meet new regulatory requirements
- Review of dossier against plant documents and/or ICH/CHMP/national guidelines prior submission to authority
Dossier build
Dossier build
Preparation of the most comprehensive and well written dossier modules is one of the extremely important aspects of the application process for a healthcare product.
iReg Consulting ensures the dossiers are built with highest quality and within timeline by placing appropriate experts across all product categories and markets.
- New drug application (NDA)
- Marketing authorization application (MAA)
- Abbreviated new drug application (ANDA)
- Abbreviated new drug Submissions (ANDS)
- Drug Master File (DMF)
- Dossier build for Emerging countries
- PMF/VAMF
- Abridged Applications
Labeling
Labeling
Labels must comply with local regulations of the destination country. iReg Consulting can provide regulatory assistance on:
Special Regulatory Services
Regulatory intelligence and Strategy for global markets
India Drug regulatory services
Special Regulatory Services
Regulatory intelligence and Strategy for global markets
Regulatory intelligence and Strategy for global markets
Current and validated Regulatory Intelligence allows the regulatory professionals to determine the requirements for global clinical trials, compliance procedures, manufacturing requirements and develop a global marketing application. iReg consultants support our clients to gather Data, analyse Information and write the Regulatory Strategy across markets and product types.
- Drugs/Medical devices/Cosmetics Regulatory Intelligence
- Regulatory Intelligence for Global Markets
- Regulatory Strategy for Emerging Markets
India Drug regulatory services
India Drug regulatory services
iReg Consulting with established experience in the Indian pharmaceutical market can help any overseas entities review the market, develop plans and implement product launches within India.
With extensive firsthand experience iReg Consulting offers following consultancy and liasioning services with drug regulatory authority of India known as Central Drugs Standards Control Organisation (CDSCO).
Following services for the New drugs, generics, API’s, Drug formulations, Cosmetics and Medical devices are offered.
- Site Registration
- Import Registration of Drugs including small molecules and biologicals and API
- Bio-equivalence/ Bio-Availability Studies NOC
- Cosmetics Import registration
- Medical devices registration
- Local agent representation
- Regulatory intelligence and strategy
- Clinical trial or CRO services
Contact us today on info@iregconsulting.com to discuss more on drug regulatory services for Indian market.
