A-pharmaconsult CMC writing for drug applications

A-pharmaconsult is a specialist in Regulatory Affairs and Quality that can provide a full range of drug application support services that depend on expertise in the Chemistry, Manufacturing, and Control (CMC) that determine product quality and safety.

These CMC writing services can be applied to product variation applications, including gap analysis, to ensure that client organizations have fully compliant documents ready to submit well before regulatory deadline.

CMC disciplines

CMC compliant dossier preparation and writing can involve preparation of gap analysis, identification of needed variation applications, and writing of the required documents to submit the dossier to the health authorities in a clear, accurate, compliant, and timely manner to speed regulatory approval.

A-pharmaconsult advice and dossier preparation support can play and valuable role in assisting pharma companies in overcoming regulatory compliance hurdles when registering products within the EU and for export countries, to implement the change control policies required to ensure national conformity and safety.

Well-presented CMC applications must use clear and consistent technical language, which in turn requires a well-structured writing process.

CMC writing is a standardized scientific and technical writing process to develop the documentation needed to support regulatory interactions and filings for CMC approval.

European Regulatory Affairs

Its CMC dossier development services include 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.

A-pharmaconsult’s specialist writers and reviewers can help prepare clearly written and accurate applications for regulatory submission to the relevant agencies, along with regulatory submissions and procedural management.

These Regulatory Affairs services can assist in various aspects of documentation and regulatory submissions including technical and quality overviews, authoring of ASMF, DMF and CEP files, PSUR writing and submission, drug product information (SPC, PIL), advertising/labelling, proofreading and translations.

Regulatory affairs in pharma

The A-pharmaconsult team of regulatory affairs specialists includes experts trained to Global Institute of Regulatory Affairs (GIRA) standards practical knowledge of regulatory agency procedures, inspections and audits, which makes them highly qualified to prepare for inspections, internal audits, vendor and supplier audits and carry out gap assessments.

It’s CMC and clinical writing expertise extends to product positioning and regulatory strategy, literature searches and documentation review, nonclinical overviews, summaries & Expert Statements in line with NCO Modules 2.4, 2.6 & 4, or CO Modules 2.5, 2.7 & 5.

Distinctively, A-pharmaconsult is also expert in the regulatory maintenance procedures, required to ensure ongoing regulatory compliance. These include compliance reviews and deficiency reports, conversion or update into CTD, management of variation applications, line extensions and renewals, and due diligence.

Effective CMC writing team

Effective CMC document writing is a team activity that involves close collaboration between multiple technical disciplines and teams.

A-pharmaconsult team includes CMC regulatory experts, professionals well-versed in R&D technical disciplines and Subject Matter Experts (SME) in products, processes and QA/QC quality management. This expertise is backed by trained writers highly versed in all relevant clinical, medical and scientific regulatory affairs fields with in-depth experience in regulatory compliance consultancy.

A-pharmaconsult works across Europe in both clinical regulatory affairs and 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.