Drug Product Regulatory

Drug Product Regulatory

ANDA SUBMISSIONS AND APPROVALS

505(b)(2) and 505(j) ANDA Application
Development
  • • Controlled correspondence with CDER, FDA
  • • PDR review
  • • Specification review and approval
  • • Technology transfer protocol and data review
  • • Pilot & pivotal batches strategic advice
  • • Manufacturing record review
Scientific Script
  • • ANDA overall assessment form
  • • Master Checklist for ANDA
  • • NDC number reciept
  • • GDUFA fees
  • • EIR evaluation
  • • Response to DMF assessment questions
  • • Labelling formation
  • • Module 1 package
  • • CMC data review
  • • Accurate detailing of Module 3
  • • Articulation of Module 2.3 and 2.7
  • • eCTD conversion
ANDA submission & Approval
  • • Electronic submissions to CDER, FDA
  • • Prompt resolution of deficiencies to comply refuse to receive decision
  • • Review deficiencies's response submission
  • • Action on Complete Response (CR)
  • • Tentative approval or Final approval letter action
  • • Submission of labelling

EU MAA SUBMISSION AND APPROVAL

  • DCP slot booking
  • MA holder based out of EU
  • EU QP Audit
  • QP Batch release Site identification
  • PIL & Bridging study
  • EU QP PV
  • m1 package
  • m2- 2.3, 2.4, 2.5, 2.6 and 2.7 scientific writing
  • m3- CMC data review and module 3 script
  • m4 and m5- based on scientific articles
  • Electronic submission to RMS and CMSs
  • RMS Query response (D100)
  • Receipt of Product LIcense
  • Submission in each CMSs for MAA and pricing approval

MAH & MEDICINES IMPORT IN EU

  • Local Legal Establishment in EU to:
    • Hold Marketing Authorisation for Drugs
    • Perform EU QP audit
    • SME status to avail regulatory fees reduction
  • Local Liasoning firm with regulatory authorities for DCP procedures
  • Tie up with local wholesale distributors and importers for QP Batch release and import agreements

ANDS - TPD Canada

  • Regulatory strategic advise for generic product development against CRP (Canadian Reference Product).
  • Scientific writing of ANDS (Abbreviated New Drug Submission) in CTD format compliant to regulatory norms.
  • Drug Identification Number Application (DINA) Submission.
  • Support in resolving screening deficiency and NOD (Notice of Deficiency).
  • Expedite DIN and Notice of Compliance (NOC) or Notice of Compliance with Conditions (NOC/c) license.
  • Natural Health Products (NHP) Site License, Labelling, Product Licensing and Post Licensing compliance support.

WHO PQP - ESSENTIAL MEDICINES REGISTRATION

WHO PQP - Speedy Access in 35 Emerging Economies

WHO
PQP EOI

WHO
PQP EOI

GMP
INSPECTION

GMP
INSPECTION

DOSSIER
EVALUATION

DOSSIER
EVALUATION

WHOPAR
 

WHOPAR
 

COLLABORATIVE
PROCEDURE

COLLABORATIVE
PROCEDURE

35 MARKETS
ACCESS

35 MARKETS
ACCESS

Approach us for speedy access to 35 emerging markets!!

Armenia

Cameroon

Ethiopia

Kenya

Malawi

Nigeria

Sierra Leone

Tanzania & Zanzibar

Zambia

Botswana

Cote’d Ivory

Georgia

Kyrgyzstan

Mali

Pakistan

South Africa

Trinidad & Tobago

Zimbabwe

Burkina Faso

Congo

Ghana

Laos

Mozambique

Philippines

Sri Lanka

Ukraine

Burundi

Eritrea

Jamaica

Madagascar

Namibia

Senegal

Thailand

Uganda

COMPETENCE & PERFORMANCE WITH EMERGING AGENCIES

  • More than 500 products approval in basket
  • Managed various dosage forms in different therapeutic areas
  • Anti-malarial and anti-retroviral dossiers submission
  • National application writing, submission, query response and approval for most of the African markets
  • Liasoned with North, East, Central, West and South African agencies
  • 5-10 dossiers submission per year in Brazil, Russia, South Africa, Mexico
  • Successfully managed ANVISA submission, local PE, CT, Disso profiling and analytical validation
  • Phase I CTA application with DCGI India
  • Fast track application with SAHPRA for first generic
  • Centralised Application for Oral solid and Topicals
  • GCC GMP inspection management
  • National application in each of GCC markets successfully managed

COMPETENCE &
PERFORMANCE WITH REST OF THE WORLD MARKETS

  • First ever cytotoxixc injectables approval in Kazakhstan
  • More than 1000 approvals in Rest of World markets in different therapeutic areas

Drug Product Regulatory - Case Studies

Read our most challenging projects for ANDA, ANDS, DCP, ANVISA Brazil and more