Dossier
Registration dossier preparation, compilation and review (CTD, ACTD, region-specific guidelines) plus filing to domestic and international regulatory bodies.
Learn moreRegulatory affairs consultancy
Solving the regulatory puzzle.
Regulations are the backbone of any industry. In healthcare this segment involves human lives, and better jurisprudence results in quality healthcare products. Regpace is a team of professionals who help you fix hectic regulatory situations in competitive, compliant ways.
Stringent markets are strengthening their regulatory systems while nascent markets are upgrading theirs and closing loopholes, resulting in Good Regulatory Practices. Pharma players face product cancellation, market withdrawal and penalties — survival of the fittest is the only theory in the present competitive scenario.
What we do
Seven services covering the full regulatory lifecycle
Pharmacovigilance
Setting up the PV department or aggregate reporting — PSUR, PSMF, PADER and PBRER — with case processing and signal management.
Learn moreCDSCO liaisoning
Product registration, shelf life extension, test licence and export NOC across New Drug, Import, Biological, Medical Device, Cosmetic and LVP divisions.
Learn moreAttestation
Document attestation, legalisation and apostille from Chamber of Commerce, Ministry of External Affairs and embassies.
Learn moreDesigning
Pharma design requirements from logo to artwork, and brochures to conference booth designing.
Learn moreTranslations
Translation of technical documents of a medical nature into a number of languages by world-class medical translators.
Learn moreSugam
Online submissions and approvals through the Sugam portal of CDSCO, with technical hand-holding throughout.
Learn moreSectors
Where we work
Pharmaceuticals
Primary focus — APIs, finished formulations, INDs, NDAs, FDCs, BE/clinical strategy, variations and renewals.
Biologicals
Vaccines, stem cells, blood products and recombinant products — Form 44/46, Form 29 and test licences.
Medical devices & diagnostics
Notified and non-notified devices, Form 27/28/29/44/46, Registration Certificate (Form 41) and import licences.
Cosmetics & nutraceuticals
Manufacturing (Form 32/32A), Form 37, Registration Certificate (Form 43), labels and claim review.
How we work
A disciplined submission process
01
Gap assessment
Review of your product, data package and target markets.
02
Regulatory strategy
Pathway selection, timelines and risk mitigation.
03
Dossier build
Authoring, compilation, publishing and validation.
04
Approval & lifecycle
Query responses, variations, renewals and vigilance.
Planning your next submission?
A quality dossier, complete in all respects, shortens the approval process — and is directly proportionate to revenue generation.