Regulatory Services
- Documents review
- Dossier Preparation and Compilation (Including ACTD. CTD and eCTD format)
- Drug master file (DMF) compilation for open and closed part
- Preclinical and Clinical studies
- Prepare summary of product characteristic (SmPC), Packaging Insert.
- Post submission Support/ Handling Queries
Pharmacovigilance
Pharmacovigilance is now an essential component of the clinical development process. We will significantly reduce costs. Increase expertise and assist you maintain regulatory compliance. Standard operating procedures and their updates, periodic safety update reports (PSURs) and working procedures supporting pharmacovigilance activities carried out within your organization such as risk minimization initiatives, handling safety information from product quality complaints and inquiries are all areas we assist with. We also support market research.
Clinical Services
Our clinical services are a one stop shop for everything you need to manage and keep an eye on clinical trials in a variety of therapeutic areas, including monitoring BE studies in India. Knowing that we are handling the management of all your assets will allow you to sleep easy.
eCTD Services
Elevate your regulatory compliance with our expert eCTD services. Our comprehensive solutions for electronic common technical document preparation and submission ensure seamless integration into the regulatory affairs landscape. From document conversion to meticulous validation, we tailor our services to meet the highest industry standards. Trust us to navigate the complexities of eCTD, ensuring your submissions are not only accurate but also in full compliance with regulatory requirements
- We assist you by offering comprehensive solutions for all requirements pertaining to regulatory submissions, including electronic filings.
- Offering knowledge of all eCTD requirements when prompted by relevant data.
- We facilitate multi-country filings, data compilation and data publishing because of our extensive understanding of global regulatory publishing trends and submission.
- Guaranteeing the privacy of clients.
Artwork design
You can get assistance from our packaging design experts in creating packaging that is specific to your products. We manage your package design project from the first concept to the finished result.
Years of design expertise are utilized by our imaginative packaging designers and production team to deliver exceptional service and value. Out staff can help you come up with packaging and display concepts that will attract end customers and encourage them to purchase your goods.
These services include the following:
- Cartons
- Patient information leaflets (PIL)
- Label
- Blisters
- Tubes
- Sachets
