Regulatory Services - UK
With Brexit, the MHRA became a standalone regulatory authority for medicines and medical devices in the UK. Medicinal products can only be placed on the market in the UK pursuant to a UK national marketing authorization (MA) granted by MHRA.On account of Northern Ireland (NI) continuing to follow EU rules, UK MAs are now split into various types, depending on the parts of the UK to which they apply. In particular,
the EU “centralized authorization” granted by the European Commission, which allows a medicinal product to be placed on the market in all EU Member States, no longer applies in Great Britain, but does, for now, apply in NI. MHRA will regulate and authorize all medicines in NI under a UK-wide marketing authorization granted in line with UK law.
We deal with following Application Types:
- Generic MAAs - Regulation 51 of the Human Medicines Regulations 2012
- Hybrid MAAs - Regulation 52 of the Human Medicines Regulations 2012
- Well-established use MAAs - Regulation 54 of the Human Medicines Regulations 2012
- Informed consent MAAs - Regulation 56 of the Human Medicines Regulations 2012
- Change of Ownership Applications
- Active Substance Master Files
- Investigational Medicinal Product Dossiers
Contact us for the applications under the National and International Recognition Procedure (IRP). We offer following services for UK.
| Technical Documentation Review | Drafting convincing scientific justifications |
| Authoring CTD Module 1 to 5 | Labeling and SmPC |
| Quality Overall Summary | Gap Analysis of legacy product dossiers |
| Clinical and Non Clinical Overviews/Summaries | eCTD preparation & Submission |
| MAAs/DMFs/CEPs/IMPDs | Administrative Documentation |
| Technical documentation preparation/Review | MAH representation to agencies |
| Scientific Advice | Life Cycle Management | UK Lab Testing |
| Meeting Requests | Variations | Importation |
| Key questions to ask | Renewals | QP Release |
| Meeting packages | Extensions | OLS identification |
| Meeting Presentations | Self-Certifications | |
| PIQ Assessments | ||
| User testing & Bridging Reports | ||
| Sunset Clause |
Regulatory Services – EAEU
Understanding the Regulatory Framework of Drug Registration in Eurasian Economic Union (EAEU)
The EAEU consists of Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan and is headed by the Eurasian Economic Commission (EEC).
The ‘Rules of registration and expertise of medicinal products for human use’ (EEC Decision No. 78) of November 3rd, 2016 describes two pathways of registering drugs in the EAEU, which have become the official procedures at the start of 2021. Drugs registered before December 31st, 2020, need to comply with the EAEU requirements by the end of 2025.Align the dossiers of your previously registered drugs as per the new unified procedure with our experts. We have a team of in-country experts to support EA-EU procedures for pharma
and complementary medicines.
| Selection of Reference Country | Translations |
| Normative Documents | SmPC, Labeling, Instructions for use |
| Testing of drug products | eCTD submissions |
| Query-response phase | Compliance of approved dossiers to EAEU requirements |
| EAEU GMP Inspection | Issuance of Registration certificates |
Contact us for EAEU Registration of Drug Products and API
Regulatory Services – WHO Prequalification
WHO prequalification helps in tapping the potential of donor-funded market. By prequalification, WHO verifies the quality of APIs and FPPs that are urgently needed in middle and low income countries. Prequalified products are procured by United Nations Agencies, Global Fund, National Governments and Ministry of Health, NGOs such as Médecins Sans Frontières.
WHO medicines prequalification ensures that active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) are safe, appropriate and meet stringent quality standards. The principal medicines prequalification activities are: assessment of product dossiers (for FPPs) or master files (for APIs); inspection of manufacturing and clinical sites; and organization of quality control testing of products. These activities form part of WHO's broad access agenda which seeks to expand access to quality-assured medicines.
| FPP Prequalification | ePQS submissions |
| Query-response phase | Collaborative Procedures |
| QOS and QIS | Protocol guidance |
| PQ dossiers for API | Pre-submission meetings |
| PQ GMP Inspection | API Prequalification |
Regulatory Services – ASEAN
The ASEAN region comprises of Malaysia, Indonesia, Thailand, Philippines Singapore, Brunei, Vietnam, Laos, Cambodia, and Myanmar. Despite the regional harmonization initiatives, the regulatory process for obtaining Marketing Authorizations (MAs) for drugs in ASEAN region is highly country-specific. The un-written procedures, ad-hoc requests and immediate implementation of new regulations are not uncommon. This is further complicated by the requirements of one site-one registration policy in most of the ASEAN countries.While Malaysia and Singapore have provision for the electronic submissions, other ASEAN countries are still paper based. Further an additional “A” in the CTD in the acceptable dossier format needs re-writing and re-compilation of CTD formats that are normally prepared by companies.
Thus, a strategic planning and a quick turnaround response to ad-hoc requests during review of applications is the key for successful and timely product approvals in ASEAN countries. Off load your repetitive regulatory work for ASEAN countries to us for faster approvals and launch.
Contact us for
| CTD to ACTD conversions | Country specific formats for technical documents |
| Resolution of review queries | Gap analysis for screening queries |
| GMP clearance applications | Identification of suitable partners |
| COPPs from other countries | Local clinical/Bioequivalence studies |
Regulatory Services – Middle-east
The registration processes for pharmaceuticals in Middle Eastern countries are varied. While the processes are evolving in few countries, ambiguity prevails in many other countries. The GCC procedure in member countries (countries (Bahrain, Oman, Kuwait, Saudi Arabia, Qatar, and the United Arab Emirates) has achieved some success in improving the efficiency and consistency of drug registration within the region. However, each member state ultimately retains sovereignty over its regulatory decisions, which can lead to inconsistencies in practice. Local companies have been collaborating with foreign companies to overcome regulatory challenges and bring products to the market faster. Reach out to us for development, technology transfer collaboration and registration in middle east countries.
| Technical Documentation Review | Company Registration |
| Authoring CTD Module 1 to 5 | Gap Analysis of legacy product dossiers |
| Quality Overall Summary | eCTD preparation & Submission |
| Clinical and Non Clinical Overviews/Summaries | Support for Inspections |
| MAAs/DMFs/CEPs/IMPDs | Response to inspectional observations |
| Technical documentation preparation/Review | Life cycle management |
| Drafting convincing scientific justifications | Support for first time launches |
| Technology Transfer | Sourcing and qualifications |
Regulatory Services – Africa
Although harmonization of drug approval in several economic zones in Africa have being much talked about, drug registration requirements continue to be varied in each country. We help companies in compiling their submissions to various African Drug Health Authorities. Leverage our regulatory potential for South Africa, Tanzania, Zimbabwe, Botswana, Zambia, Kenya, Uganda and other SADC (South African Development Community) and EAC (East African Community) member countries.
| Conversion of MBR1/MRF1/national formats to CTD dossier | Country specific formats for technical documents (QIS/QOS/BTIF) |
| eCTD/uploading dossiers in portals | Gap analysis for screening queries |
| Facilitating GMP inspections | Identification of suitable partners |
| Facilitating Laboratory Testing | Identification of local partner companies in SADC and EAC member countries |
| Bio-waiver justifications | Justification for use of foreign Reference Product |
Regulatory Services – CIS
The CIS region includes EAEU countries Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan as well as other countries like Ukraine, Uzbekistan, Tajikistan, Turkmenistan, Azerbaijan, Moldova, and Georgia. Drawing inspiration from the Russian procedures, the independent countries forged their own paths in drug approval processes and built up complex procedures over the last two decades.
While the EAEU countries are aligning with EU standards, the intricacies in the regulatory framework of other countries is still daunting. A key for drug registration success in CIS countries is to partner with local companies. Local entities not only provide an insight into the complex regulations and guidelines but also help companies adapt to the ever-changing regulations. We work with local experts in CIS countries to
help build your registration portfolio. Our services in CIS countries include:
Our services in CIS countries include:
| Submission of dossiers/DMFs | Translations |
| Normative Documents | SmPC, Labeling, Instructions for use |
| Local clinical trials | Testing of drug products |
| Query-response phase | Submission of amendments/variations |
| GMP Inspection/Clearance | Issuance of Registration certificates |
Regulatory Services – Australia
Regulatory framework of drug registration in Australia has evolved over a period of time. The procedures are established but are resource intensive. We provide regulatory oversight for the products developed for Australia from development stage to commercial manufacturing. This includes providing end-to-end support during drug development and registration process in Australia.
| Extension of EU/US dossier to TGA dossier | Gap analysis & remediation |
| eCTD dossier/DMF submission | Assign local agent/partner companies in Australia |
| Facilitating GMP inspections by TGA | Identification of suitable partners |
| Facilitating GMP Clearance applications | Preparation of PI and CMI |
| Bio-waiver justifications | Justification for use of foreign Reference Product |
| Pre-Submission meetings | Submission of pre-submission planning forms |
| Category 1, 2, 3 Applications | Self-assessable requests |
| Response to S 31 Requests | Life cycle Management |
Reach out to us for submissions in New Zealand.
Regulatory Services – USA
Whether your company has an extensive product lineup or operates on a smaller scale with a handful of products seeking approval in the USA, Maira offers a strategic alternative to managing an in-house regulatory team. By entrusting your regulatory operations to us, you not only cut down on the costs associated with maintaining a dedicated team but also gain the freedom to concentrate on expanding your business.As you navigate the path of business growth, let us handle the intricate task of preserving the regulatory well-being of your company.
Our comprehensive services for the USA include:
| Regulatory Operations | Administrative |
| Authoring and compilation of ANDAs/NDAs/DMFs/Pre-INDs/INDs | Labeler code |
| eCTD conversion & Validation | DUNS issuance |
| Submission through ESG | Establishment Registration |
| Controlled Correspondences | Drug Listing |
| Responses to Information Requests and CRLs | US agent services |
| Annual Reports preparation | |
| Authoring CBE 0/CBE 30/PAS amendments | |
| US FDA inspection readiness | |
| Response to 483 observations |
| Meetings with FDA | Special Requests |
| Pre-IND/EOP1/EOP2/pre-NDA/Advisory Meeting requests | Expedited pathway |
| Preparation for Key questions to ask | Orphan Drug Designation |
| Preparation & Submission of Briefing Packages | Breakthrough Therapy |
| Meeting Presentations and record of discussion | Protocol Assistance |
Regulatory Services – Europe
In Europe, a vast interconnected network of diverse countries and languages is bound together by shared legislation. The regulatory requirements may vary subtly from nation to nation. Our expertise in European regulatory services provides seamless compliance for pharmaceutical products across all developmental phases, from inception to market launch and post approval life cycle maintenance in national, centralized and decentralized procedures. We prepare high-quality and review technical documents for submission to regulatory authorities. Reach out to us for management of country specific MAs or entrust us with full regulatory portfolio management.
We offer following services for Europe:
| Technical Documentation Review | Labeling and SmPC |
| Authoring CTD Module 1 to 5 | Gap Analysis of legacy product dossiers |
| Quality Overall Summary | eCTD preparation & Submission |
| Clinical and Non Clinical Overviews/Summaries | Administrative Documentation |
| MAAs/DMFs/CEPs/IMPDs | MAH representation to agencies |
| Technical documentation preparation/Review | Support for Inspections |
| Drafting convincing scientific justifications | Response to inspectional observations |
| Scientific Advice Requests & Meeting Packages | Life cycle management |
| Geographic Expansion | Support for first time launches |