- Quality and Scientific Regulatory Services for Global Bio-/Pharmaceutical Industry
Drug Product Regulatory – India & Other Markets
Drug Product Regulatory – India & Other Markets
INDIA REGULATORY SUPPORT
With our team experienced in handling India regulatory services, we are well placed to provide end-to-end regulatory support for products across categories including Pharmaceutical, Food, Nutraceutical, Cosmetic, Medical Device, Diagnostic Kits, Biologicals and Vaccines. We can offer the following services, depending on the client needs:
- Commercial assessment of products to define market attractiveness in India
- Defining regulatory pathway for India filing and approval
- Dossier writing for India and documentation/ licensing support as applicable
- Filing for products through SUGAM portal as applicable
- Support on query resolution to assist in timely approval
- Act as registration holder/ authorized agent in India
- Assistance in identifying and finalising local marketing & distribution partners
For more information on Biologicals and Vaccines for India, click here.
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
- • 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
PROFICIENCY 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
Drug Product Regulatory - Case Studies
Read our most challenging projects for ANDA, ANDS, DCP, ANVISA Brazil and more