What we do

Regulatory Affairs (End to End Pharma Regulatory Services for Solid Oral, Steriles, Biologics, Biosimilars, Cell Therapy & Medical Device- Initial marketing authorizations, post approval change management and submissions across the globe.

Drug Development (Pre-Approval) and New Product Filing across the globe: Development & execution of regulatory strategy for submission, IND/IMPD (CTA), CTA Amendments, Scientific Advises/Briefing Books, Agency meetings (pre-submission / INDs), Controlled Correspondences, Bio Correspondences, Suitability Petitions, Citizen Petitions, HA interactions, Bio waiver Expertise, PIP, Waiver/Deferral.

Marketing authorization applications/new submission: (NDA, ANDA, MRP/RUP, DCP, CP, NP, BLA, Biosimilars) for EU, US, Canada and other ROW countries.

Drug Substance Registration and post approval change management: ASMF, DMF, CEP, PMF, VAMF

Post approval (Product Lifecycle Management): Change control/deviation assessment, Annual report, Renewals/License Maintenance, CMC/administrative/labeling/safety Variations/supplements, Article 61.3, Query management, Scientific Advice/Briefing Book, MAH transfer (Change of Ownership), PIP, Waiver/Deferral, PIP AR, Post Authorization measure (PAM), Article 46, Post authorization safety Study (PSS), Tracking Sunset Clause and request for extension of MA validity /exemptions as applicable, withdrawal, Dossier audits (gap analysis), dossier harmonization, process improvement, RUP, line extension, Geo/market expansion.

Regulatory Operations:
a)Regulatory information Management, eCTD content management, Submission document management (Publishing) & tracking, eCTD creation and publishing, b)Launch support, maintain oversight on publication and validation of dossier and other supplements documents through tools like RIMS-Veeva, eSUB, Educe eCTD, LORENZ docuBridze eCTD, Rosseta Phoenix, TEDI, CREDI, REDI, RIMS-Dragon etc.

Regulatory Strategy/Regulatory project management:
Submission Forecast Planning and Prioritization, Risk identification, communication & mitigation, Pre- HA Meeting.

Regulatory Compliance:
GMP & Site Audit Support, Internal Audits, continuous process improvement, fit to strategy, gap assessments, issues/risks mitigation measures.

Regulatory Intelligence Services

GXP & QMS Compliance: Change Control & Deviations Management.

Data Integrity & Compliance Support

Labelling/Artworks:
Product Information/ Artwork & CCDS update, FMD/QRD Updates, Mock-up reviews, article 61.3 Safety Related Changes submission: PRAC recommendation, RLD Update.

Pharmacovigilance Activities: Periodic Benefit-Risk Evaluation Reports (PBRER)-PSUR/DSUR/PADER. Risk Management Plan (RMP) Pharmacovigilance Site Master File (PSMF)

Impurity Assessment: Exposure limit assessment (PDE/ADE), Genotoxicity assessment, Nitrosmine etc.

Liasioning support- BA/BE NOC, Manufacturing License (Form 28/25), COPP, FSC, GMP renewal, DUNS.

Market Access & Regulatory Intelligence

Publishing & Submissions

Regulatory Artwork Services

Regulatory Writing Services

Compliance, Audit and Validation:
GxP Audit Services
Computer System Validation and Computer Software Assurance
End-to-End Compliance Services
Remote and Virtual Audit
Vendor Qualification & audit support

Training & Skill development

Mergers & Acquisitions Consulting