Services

Drug Product Regulatory

End to End Regulatory Services covering Regulatory Strategy, Scientific Dossier Writing, Submission to Health Authority, Exigencies response, Pricing approval, Marketing Authorization Approval & Product Life Cycle Management.

Master File Submission (API)

DMF/ASMF/CEP scientific writing, Submission with Agency, support in resolving questions, Third Party API QP audit, QP audit Report, CAPA preparation, QP Declaration, CEP Certification, EDQM GMP support.

EU GMP Excellence

GMP pre-audits, Compliance advise and bridging support, QMS documentation, Facility upgradation advise, mock up inspection, QP audit, EU GMP inspection to certification hand holding, annual report submission.

PIC/S GMP Proficiency

Product trigger GMP inspection from Malaysia, Regulatory Submission, MA Holding, ACTD dossier writing, Deficiencies closure, hand holding for GMP improvisation, Product approval & Site GMP accreditation, Market support.

Biosimilar Intelligence

BLA review, Scientific writing and CBER submission under 351(k) pathways with USFDA, Centralised application under Article 10(4) with EEA, Expert intelligence for biosimilar licensing in BRICS-TM markets.

Regulatory Training

Customised training for multiple technical topics based on current norms, GMP specialized training sessions, Regulatory training for product development, dossier writing, CTD management and Life Cycle Management.

GxP Calibre

Clinical or BE center GCP preparation and PIC/s or EU inspection arrangement, Toxicology or Analytical Laboratory support for OECD accreditation, Annual audit and gap analysis report.

Global Dossier Development

Technical guidance to develop global dossier, Conversion of non-CTD to CTD and eCTD dossier, National dossier writing, Country specific guidance and check lists, Gap evaluation of in-licensed dossier.

Product Life Cycle Management

Renewal, re-registration, Annual report, Variation submissions & approvals, line extension management, Registration maintenance, PV compliance, technology transfer documents evaluation & approval.

Ethical Standards

Compliance to highest ethical standards

Knowledge

Highly knowledgeable and experienced internal experts

Dependable

Time bound project execution

Success

100% success for EU GMP and regulatory services.

Compliance

ANDA filing with full compliance with RTR standards.

Integrated

Integrated services for regulatory filing in EU via DCP / Centralised / National procedure.