Drug Product Regulatory – EU, UK, Australia, US, Canada, WHO & Emerging Markets

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Drug Product Regulatory – EU, UK, Australia, US, Canada, WHO & Emerging Markets:

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

EU, UK MAA SUBMISSION AND APPROVAL

EU/UK LEVEL ASSISTANCE

DCP slot booking
Local Legal Entity Establishment
1. Holding Marketing Authorisation
2. EU/UK QP Audit
3. SME status evaluation to avail regulatory fees reduction
4. EU/UK Batch release Site identification
5. EU QP PV identification
6. Local Liasoning with regulatory authorities for DCP procedures
7. Tie up with local wholesale distributors and importers for QP Batch release and import agreements.
PIL & Bridging study

MAA SUBMISSION

Scientific document review
Dossier Gap Assessment
Scientific dossier writing and CTD compilation
1. Module 1- Administrative package preparation
2. Module 2 & 3- CMC data review and writing
3. Module 4 & 5- Based on scientific literature

PRODUCT LICENSE AND MARKET APPROVAL

Electronic submission to RMS (EU) and CMSs (EU); National procedure (UK)
RMS Query response
Receipt of Product License
Post approval change filing support

AUSTRALIA REGULATORY SERVICES

Metina takes up end-to-end regulatory support for Australia for Prescription and OTC products. With a subsidiary in Australia, Metina Australia Pty. Ltd., we are well equipped to provide services such as gap analysis of dossiers from Australia perspective, writing of scientific dossier, conversion of CTD to eCTD via software, filing with TGA, query resolution and approval. We can additionally handle S19A and SAS pathways.

Metina has carried out several TGA Compliance Verifications for GMP approvals (through Desktop Assessment) of pharmaceutical facilities and is also equipped to hold Marketing Authorizations as sponsor along with facilitating local marketing & distribution tie-ups.

ANDA SUBMISSIONS AND APPROVALS

505(b)(2) and 505(j) ANDA Application

Development

Controlled correspondence with CDER, FDA
CMC document review (PDR, Specification, BMR, BPR, PV, AMV, Stability studies, etc)
Assistance for technology transfer
Pilot & pivotal batches strategic advice

Pre submission support

Local Legal Entity Establishment (US agent)
Assessment of ANDA Application form
Master Checklist for ANDA
Liasoning for receipt of Control Correspondence number, ANDA number, DUNS number, NDC number

Scientific writing

Module 1 package preparation (labels, artworks, etc)
CMC data review
Module 2 & 3 authoring and compilation.
Response to Information request (IR), Discipline Review Letter (DRL), Complete Response Letter (CRL)
Module 4 & 5 support (as applicable)

ANDA Submission & Approval

ANDA eCTD submissions to USFDA ap
Control correspondence submission via CDER Direct Nex Gen Collaboration Portal
Compliance of dossier review with respect to refuse to receive (RTR) guidance.
Review deficiencies’ response submission
Tentative approval or Final approval letter action
Support for lifecycle management and post approval change submission (CBE-0, CBE-30, PAS, Annual report)

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.

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

WHO PQP - ESSENTIAL MEDICINES REGISTRATION

WHO PQP - Speedy Access in Emerging Economies

WHO
PQP EOI

GMP
INSPECTION

DOSSIER
EVALUATION

WHOPAR

COLLABORATIVE
PROCEDURE

MARKETS
ACCESS

Approach us for speedy access to 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

INFORMATION ON ACCESS CONSORTIUM

End–to–end regulatory support for dossier submission to ACCESS countries

The 'ACSS' consortium, formed in 2007, comprises of the national regulatory authorities of Australia, Canada, Singapore and Switzerland. ACCESS – In October 2020, the United Kingdom regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – joined the consortium and the group's name was changed to 'Access’. The consortium's goal is to maximize international cooperation, reduce duplication, and increase each agency's capacity to ensure patients have timely access to high quality, safe and effective therapeutic products. Pharmaceutical companies that submit applications to some or all Access countries will benefit from having their products evaluated for marketing in those countries simultaneously, with reduced evaluation times.

TGA - Australia

Regulatory guidance & advice on TGA Biosimilar guidelines “Biosimilar Medicines Regulation, Version 2.2, 2018”

HC-BRDD - Canada

Regulatory guidance & advice on HC/BRDD Biosimilar guidelines “Guidance Document: Information & Submission requirements for Biosimilar Biologic drugs, 2017”

MHRA - United Kingdom

Regulatory advice on “MHRA guidance on the licensing of biosimilar products, October 2020”

HSA - Singapore

Regulatory guidance & advice on “Guidance on Therapeutic Product Registration in Singapore, December 2020”

SWISSMEDIC - Switzerland

Regulatory guidance on Swissmedic Biosimilar guidelines “ZL101_00_012e_WL Guidance document Authorization biosimilar HMV4, V3.1,2021”

REGULATORY SUPPORT FOR EMERGING MARKET SUBMISSION

End-to-end regulatory support for MAA submission in Brazil, Russia, India, South Africa, BRICS – TM and other ROW markets:

Regulatory Due Diligence of Technical Data against prevailing guidelines of the respective country.
CTD/ACTD/Country specific dossier compilation
Support for pre-submission advisory meetings/ Scientific advice packages, agency meetings
Representing MAA review committees at agency level
National application writing, submission, query response and approval