Regulatory Services

Regulatory due diligence and strategy

The due diligence process deserves patience, planning and thought to incorporate disciplines, information, and depths of technical knowledge. Strategic and due diligence can be crucial in delivering verified, quantitative expertise and the quality of data sought is essential. Our expert team focuses and supports a thorough due diligence examination. We strive to find problems or areas of concern regarding past data, results, or the possible future viability of the asset. We provide a strong due diligence process that demands manifold scientific and regulatory expertise that guarantees an authentic and holistic evaluation.

Gap Analysis

When your organization faces new amended laws and regulations, it can be challenging to determine if and how you’re existing policies and procedures need to be modified. A gap analysis is accomplished at the start of the journey and whilst the audit is at the end. We, Atop Pharma Solutions can help you by performing a regulatory gap analysis. During a gap analysis, we specify the capacity to which your organization complies with laws, regulations and which actions you need to take to be compliant. Our approach to performing gap analysis is to map out current policies and procedures, systematically outline the legal framework, determine which legal requirements the organization needs to meet. We also identify and analyze the gaps and make tangible suggestions on how to fix these gaps

MAA dossier – review and compilation of modules 1 to 5

As the European regulatory system strives to ensure delivering safe, efficient, and quality medicines to their citizens the documents submitted to the health agencies should comply with all the ICH requirements as well as country specific requirements related to submission for marketing authorization. We provide end to end services for dossier compilation with utmost accuracy and in compliance with all the regulatory requirements.

eCTD/NEES publication services

Atop Pharma Solutions provides regulatory publishing services (eCTD and NeeS – eSubmission Management, Document Level Publishing) solutions for pharmaceuticals, biological, and life-sciences industries across the globe. eCTD is a more powerful option, encouraging dossier and lifecycle maintenance and navigation via an XML backbone. NeeS is practically a cluster of files organized in a series of folders with granular PDF files, electronic tables, and electronic navigation bookmarks and hyperlinks. NeeS is determined by country-based guidelines.. We have an expert team in all kinds of electronic submissions (eCTD and NeeS) and PSUR / PADER) submission for the North America, Europe, Asia and rest of the world. The high quality softwares that we use, comply with all regional and ICH standards.

Product information preparation – SPC, PIL and Labelling

Product information is a very important part of administrative requirement for filing in any country. We specialize in preparation of all product information documents which comply with all the regulatory requirements of that specific country.

Readability Testing and Bridging report

The readability of the labeling and package leaflet of medicinal products for human use is a mandatory requirement in EU region. Readability User Testing is an essential part of product compliance and it is designed to guarantee that product leaflets are legible, clear, and easy to use for patients. It provides a set of intelligible information, enabling the use of the medicinal product safely and suitably. We provide bridging report and bridging statement services in the situations where the leaflets are adequately similar or identical to the reference product in both content and layout format. A bridging report with focus testing is performed in case of a bigger dissimilarity between the two PIL’s. Bridging reports can also be incorporated into the PIL testing package. We ensure to help you with all your readability and bridging documents with our expert team.

Translation of pharmaceutical documents

When a company is looking to sell a product abroad, there are many requirements like legal, packaging, documentation, etc. Most countries demand that text on any product that is to be sold in their country should be translated into one of their official languages. That will help their customers to understand the drugs. All product information, descriptions, names, titles, etc. should be translated accurately. We provide all translations related to regulatory documents like dossiers, product information, manufacturing records, SOPs etc with utmost accuracy as they are translated by highly trained translation experts.

Local regulatory support (e.g., local representative, preparation of locally required documentation)

We specialize in country-level regulatory support and act as the local regulatory unit for pharmaceutical companies and cohorts across different countries. Local representatives are appointed for all country-specific requirements and each step is as per the regulations of Global Health Authorities. Our representatives assure compliance throughout the procedure. Thus, our expert team acts as a crucial link between the organization and Global Health Authorities. They track all the fundamental principles related to the product and pre-requisites. We act as a specialized Global Regulatory Affairs partner as a link between organizations and key regulators.

Deficiencies management

The CTD dossier is addressed through proper scientific evaluation by our expert team. Pharmaceutical companies should confirm that products are manufactured batch by batch, year upon year, to the appropriate and consistent quality standards and should comply by regulatory guidelines. We address all the queries related to deficiencies from the heath authorities.

Lifecycle maintenance: variations (Type IA, IB, II), renewal, and MA transfer, ‘sunset clause’ exemptions package, withdrawal 

We provide regulatory support throughout the lifecycle of products. Many variations are required to keep the dossier up to date during the lifecycle of a medicinal product. Our services are customized to your needs and cover all aspects of lifecycle management like preparing variations, managing MA renewals, sunset clauses and withdrawals.

MA duplication procedure

We take care of duplication of the authorization obtained for one region to the other regions as per the regulatory requirements of the specific countries.

Regulatory services for specific countries e.g. LATAM, CIS + ex members, ASEAN, South Africa, ANZ, Botswana, Switzerland, etc.

For specific regulatory services related to markets like LATAM, CIS + ex members , ASEAN, South Africa, ANZ, Botswana, Switzerland we provide services for dossier preparation, deficiency management and lifecycle management.