Services

Pharma Export/Import Registration

We have hand on experience of product registration for export market across the world. We have more than 1200 CTD dossiers ready along with drug master file, analytical method validation and comparative dissolution profile. We are capable to compile CTD dossier within a day.

If you are planning to enter into Pharma export then you should have ready CTD dossier list with you to make a deal. Noteworthy you should have trustworthy outsourcing partner who can handle query reply of any FDA within the timeline and in a proper way. Our expert team can give you CTD dossier and its query reply on time without follow ups.

We offer guidance throughout the entire process, from product selection and buyer selection to country selection. Our expertise extends to providing insights into multiple export strategies, ensuring a fast track return on investment (ROI).

Ready
CTD Dossier

Timely Submission

Timely
Query Reply

Buyers
Lead

Business
Plan

Drug Regulatory

We can compile a CTD dossier within a day, provided you have the necessary documents ready for compilation. Our Drug Regulatory Services encompass e-CTD & CTD dossier compilation and filing, ACTD & Vet dossier as well as comparative Dissolution and Analytical Method Validation. Additionally, we conduct Gap analysis of drug master file and drug product dossier. Timely responses are crucial to us.

e-CTD

CTD

ACTD

Vet-CTD

Herbal CTD

Drug Safety

Drug Quality and Drug Safety go hand in hand. We are providing end to end drug safety services from establishment of drug safety department to operational activities, audits and inspections. Acting as an extension of your team, we confidently handle conducted by national and international health authorities. Independently managing all aspects, we address submissions and respond to queries, both pre and post marketing authorization.

Establishment

PSMF

PSUR

RMP

Audit

Outsourcing

We can provide a competitive offer for services, including Bioequivalence Study, Preclinical Study, Clinical Study, Determination of Permitted daily exposure (PDE) Value of API. Our offerings that align with your budget and hold approvals compliant with various regulatory standards such as USFDA, MHRA, EMA, CDSCO etc.

We will handle your complete projects starting from selection of CRO, price negotiations, protocol clearance from CDSCO, analysis of quality of studies.