Regulatory Affairs
Regulatory Affairs Services
At Ampin's Pharmaceutical Pvt. Ltd., our Regulatory Affairs division (Ampin's Pharma Regulatory services) plays a vital role in ensuring the safety, efficacy, and compliance of every product we develop, manufacture, and market. With a deep understanding of national and international regulatory frameworks, our team ensures smooth navigation through complex regulatory landscapes.
Our Regulatory Expertise Includes (but not limited to):
Regulatory Strategy & Consultation
We provide comprehensive regulatory guidance throughout the product lifecycle—from early development through post-marketing. Our strategic input ensures that all regulatory requirements are considered early, minimizing delays and maximizing approval success.
Dossier Preparation & Submission
Our dedicated team is highly skilled in compiling, reviewing, and submitting high-quality regulatory dossiers including:
- CTD/eCTD formats for various global markets
- ACTD & Regional formats for various global markets
- Bioavailability (BA) & Bioequivalence (BE) study
- ANDA, NDA, IND, and MA Applications
- Site registration and product licensing
- Drug Master Files (DMFs)
Global Regulatory Compliance
We support regulatory submissions across multiple regions:
- ASEAN
- AFRICAN
- MIDDLE EAST
- LATIN AMERICAN (LATAM)
- ROW Markets
Liaison with Regulatory Authorities
We maintain active communication with regulatory bodies to facilitate approvals, respond to queries, and manage audits and inspections efficiently.
Labeling & Packaging Compliance
Ensuring that all labeling and packaging meet current regulatory requirements for each market, reducing the risk of non-compliance.
Post-Marketing Regulatory Support
Our services extend beyond approval with:
- Lifecycle management
- Variations and renewals
- Pharmacovigilance coordination
- Regulatory intelligence updates
