acora pharma consulting

acora pharma accompanies you during the product development, registration, launch and marketing of your medicinal product. You benefit from our extensive international regulatory experience, especially in Europe, the CIS (GUS) states and the USA. We offer the following services:

Pre-approval regulatory activities

Product Development

  • Consultation regarding implementation of regulatory requirements during each individual product development stage;
  • Participation in our clients’ product development teams;
  • Supervision of product development by third parties;
  • Preparation of documentation for scientific advice meetings;
  • Participation in scientific advice meetings as representative of the Regulatory Affairs and/or CMC Documentation (Chemistry, Manufacturing and Controls) functions.

Clinical studies

  • Preparation of the section Quality of an Investigational Medicinal Product Dossier (IMPD) and an Investigational New Drug Application (IND);
  • Preparation of the CMC section of an Investigator’s Brochure (IB);
  • Answering deficiency letters on the IMPD, IND and IB.

Product information (Summary of Product Characteristics (SmPC), patient information leaflet (PIL), labelling)

  • Preparation of the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and labelling according to the QRD Template in collaboration with the responsible departments.

Marketing authorization application

We assume all regulatory activities for your successful marketing authorization application. This includes:

  • Consultation regarding the marketing authorization procedure (national / MRP / DCP / CP procedures, WEU, THMP, registration of homoeopathic products);
  • Preparation of Scientific Advice Meetings and participation in these meetings;
  • Preparation of the entire Module 1 according to CTD format;
  • Preparation of Quality Overall Summaries (QOS, Module 2.3);
  • Preparation of the entire Module 3 documentation (Quality) according to the current CMC guidelines;
  • Compilation of dossiers for national and European applications for marketing authorization in CTD format;
  • Submission of the marketing authorization application to the competent authorities, e.g. via CESP;
  • Answering deficiency letters;
  • Communication with the competent authorities.

Active substance Master File (EU-ASMF) / Drug Master File (US-DMF)

  • Preparation of Active Substance Master Files (EU-ASMF) or Drug Master Files (US-DMF);
  • Answering deficiency letters.

WHO Certificate / Certificate of a Pharmaceutical Product (CPP)

The Certificate of a Pharmaceutical Product (CPP) has to be submitted to the health authority of the importing country as part of the licensing, new marketing authorization and renewal applications. We undertake:

  • Preparation of the CPP in accordance to the WHO format;
  • Notarization of the CPP and apostille, if mandatory.

Post-approval activities


We assume all regulatory activities for your successful variation application. This includes:

  • Evaluation of the feasibility and classification of the change according to the current guidelines;
  • Preparation of the entire Module 1 including the electronic application form;
  • Revision of the product information (Summary of Product Characteristics (SmPC), patient information leaflet (PIL) and labeling);
  • Preparation of the Quality Overall Summary or Quality Expert Statement (Module 2.3);
  • Preparation or revision of all Module 3 documents according to current guidelines;
  • Compilation of the variation documentation;
  • Submission of the variation to the competent authorities, e.g. via CESP;
  • Answering deficiency letters;
  • Communication with the competent authorities.

Company Core Data Sheets (CCDS) / Company Core Safety Information (CCSI)

We offer:

  • Comparative analysis of the nationally approved product information (Summary of Product Characteristics (SmPC), patient information leaflet (PIL)) and identification of discrepancies;
  • Compilation of the source documentation as proof regarding the individual statements in the product information;
  • Based upon the source documentation, preparation of the Company Core Data Sheet (CCDS; reference document providing information on the safety, indications, dosage and pharmacology to be implemented in the national product information) and Company Core Safety Information (CCSI; reference document with drug product safety information to be implemented in all countries);
  • Preparation and submission of national variations in order to harmonize the national product information.

Renewal of marketing authorizations

We undertake all regulatory activities for your renewal application. This includes:

  • Preparation of the entire Module 1 including electronic application form, CPP, QP declaration, etc.;
  • Revision of the product information;
  • Preparation of the Addendum to the Quality Overall Summary (Module 2.3);
  • Compilation of documentation according to CTD format;
  • Submission of the renewal application to the competent authority, e.g. via CESP;
  • Communication with the competent authorities;
  • Answering deficiency letters.

Transfer of dossiers in obsolete formats (e.g. NtA format) to CTD format

We would be happy to transfer your Quality documentation which is, for example, written in the Notice to Applicants (NtA) format to the Common Technical Document (CTD) format. If desired and in addition to the formal transfer of the approved dossier, we could check the content for compliance with the current guidelines and prepare missing documents, if applicable.


eCTD preparation (publishing)

eCTD submissions are mandatory for both national and EU applications for marketing authorization. acora pharma offers a number of services related to eCTD:

  • Processing of documents in terms of technical quality and optimized navigation (submission readiness);
  • Planning, compilation, publishing and submission of your eCTDs;
  • Assumption of eCTD lifecycle management;
  • Transfer of existing paper or NeeS dossiers into eCTD format.

We use docuBridge® or upon request your publishing software.

Purchase of marketing authorizations or registration dossiers by our clients:

In the event that you are planning to purchase an existing marketing authorization or a registration documentation, we assume:

  • Assessment of the registration dossier based upon the current health authority requirements;
  • Support in the due diligence process.

Regulatory Compliance

We have a great deal of experience in the assessment of the regulatory compliance of CMC documentation (Module 3) and product information (SmPC, PIL and labelling). As a matter of course we undertake all required activities concerning the removal of inconstistencies.

Pre-clinical and clinical documentation

We are specialists in the field of CMC documentation (Module 2.3 and 3). Our partners support us with regard to questions on safety (Modules 2.4, 2.6 and 4) and efficacy (Modules 2.5, 2.7 and 5).

Quality control / Qualified Person (QP)

The Qualified Person (QP) according to the EU Directive 2001/83/EC (“Sachkundige Person” according to § 15 of the German Drug Law) is responsible for compliance with the relevant legislation on manufacture, control and release before placing a medicinal product on the market. The QP is also responsible for the consistent and complete documentation.

acora pharma is qualified to take over this important task for you both on a short-term and a permanent basis. This covers:

  • Release of raw materials, other materials and finished products;
  • Release of clinical investigational medicinal products;
  • Correspondence with the authorities in the event of relevant changes;
  • Maintenance and improvement of the GMP status;
  • Overall responsibility for compliance with and implementation of legislation and regulations (EU GMP Guide; PQR, etc.);
  • Deviation management, OOS, CAPA, Complaint Management;
  • Planning and conducting audits;
  • Contribution to client audits and authority inspections.