A-pharmaconsult Generics & WEU Support

A-pharmaconsult is a regulatory affairs specialist consultancy for the pharma industry with specialist expertise in helping pharma companies to fast-track their regulatory submissions for generic and well-established use (WEU) drugs through to market approval.

The regulatory and dossier preparation teams at A-pharmaconsult can support pharma companies in establishing more effective ‘right first time’ regulatory compliance for medication submissions, with a portfolio of targeted services.

Generic submission services

A Pharmaconsult’s generic & WEU drug services include writing of technical (Module 3 & Module 2.3-QOS), therapeutic rationales, evaluation of bioequivalence where needed, proof of well-established use (WEU), writing of clinical overview (CO) and non-clinical overview (NCO), preparation of the various Modules (Modules 1 to 5) required in the common technical documents (CTD) to prepare the publishing into electronic document (eCTD), and checks on acceptability of reference medicine for dossier submission in all targeted countries.

Appropriate regulatory affairs strategy and knowledge are critical to determining which filing procedures are applicable for relevant EU or European Economic Area (EEA) markets, extending to effective dossier preparation and efficient regulatory submission to speed time to market.

A-pharmaconsult helps clients with regulatory submissions of all modules of the MAA including CTD and publishing into electronic technical document (eCTD) format.

Its regulatory affairs service includes:

• Dossier development:Detailed assistance with regulatory strategy development as well as writing and preparation of dossier modules to make sure that all regulatory requirements are fulfilled. Its regulatory affairs consultants can use gap analysis to identify issues to be resolved pre-submission.
• Medical and Non-clinical writing: A-pharmaconsult’s specialist medical authors and content editors can help prepare clearly written and accurate applications for regulatory submission to the relevant agencies.
• Technical writing: A-pharmaconsult’s specialist technical specialists can assist to prepare clearly written and accurate applications for regulatory submission to the relevant agencies.
• Regulatory Submissions and Procedural Management to support regulatory compliance.

Generics and WEU to market

Services further extend into bringing product to market, with assistance in developing medicines production with a contract manufacturing organisation (CMO), assistance with supply and material sourcing, and planning of biodisponibility studies using appropriate reference medicines when needed, and conducting stability and other studies according to ICH guidelines.

Available generic & WEU support can also extend into product documentation with expert medical writing services for ASMF active substance, Certificate of Suitability (CEP) files, Periodic Safety Update Reports (PSUR), Summary of Product Characteristic (SPC), Company Core Safety Information (CCSI), patient information leaflet (PIL), labelling and marketing materials.

Regulatory Compliance Consulting

A-pharmaconsult offers the whole range of regulatory services required by pharmaceutical companies for bringing generics & WEU to market and managing regulatory compliance at every stage from development to product withdrawal. These services include:

• Regulatory writing (pharmaceuticals, consumer healthcare, etc.)
• Product positioning and regulatory strategy
• Literature search and documentation review
• Nonclinical Overviews, Summaries & Expert Statement (Modules 2.4, 2.6 & 4 – NCES)
• Clinical Overviews, Summaries & Expert Statement (Module 2.5, Module 2.7, Module 5, CES)
• Quality Modules (Module 3) including QOS (Module 2.3)
• Switch core dossier for Export
• Regulatory Submission to the Health Authorities (National, MRP, DCP, International, etc.)
• Compilation of documentation for Marketing Authorization
• Preparation of Marketing Applications
• Regulatory maintenance including gap analysis
• Compliance reviews and Deficiency reports
• Conversion/update into CTD/eCTD formats
• Management of variations, line extensions and renewals
• Reimbursement/Price dossiers
• User testing
• Due diligence of Marketing Authorization Dossier.

Regulatory consultancy for generics & WEU

The A-pharmaconsult team includes medical professionals and engineers who are highly versed in all relevant clinical, non-clinical and scientific regulatory affairs fields with in depth experience in regulatory compliance consultancy.

A-pharmaconsult works across Europe in both clinical regulatory affairs and also medical device compliance, serving the needs of pharma and life sciences organisations of all kinds, ranging from mature organisations to start-up groups.

Resources

Click on A-pharmaconsult Regulatory Affairs Services  for further information.