Freyr Solutions

Freyr Regulatory team helps API manufacturers in sister CEP filing , compilation, review and submission to EDQM for all types of APIs/drug substances as per EDQM guidelines and requirements. A certification of Suitability (CEP) holder, who wishes to possess a second CEP for the same Active Pharmaceutical Ingredient (API)/drug substance, can file a new application referred as a “Sister file”. It can be due to differences in API specification obtained with alternate process or to cover alternate grade of material. This is valid for all files except sterile, TSE or herbal applications. A Sister CEP to the approved CEP filed with European Directorate for the Quality of Medicines and Health Care (EDQM), must be approved on a fast track basis compared to the approval timelines of original CEP applications.  There are pre-defined conditions set by the EDQM that must be fulfilled in order to file the sister CEP. Hence, expertise is required to file the sister CEP with the EDQM for qu...

Certification of Suitability (CEP) Submissions Freyr helps API Manufacturers in CEP compilation, review & submission to EDQM for all types of APIs as per EDQM guidelines for approval of MAAs/ANDS. CEP adds an advantage for API manufacturers while entering the EU CEP to the monographs of the European Pharmacopoeia. Filing Active Pharmaceutical Ingredient (API) Information with the European Directorate (ED) for the Quality of Medicines and HealthCare (EDQM) is not mandatory. However, possessing a Certification of Suitability (CEP) is an added advantage for API manufacturers while entering the EU. CEP to the monographs of the European Pharmacopoeia can be filed only for APIs which have monographs in European Pharmacopoeia (Ph. Eur). Most of the emerging markets, in addition to Australia, Canada and all European Union (EU) countries accept CEP instead of Active Substance Master File (ASMF)/Drug Master File (DMF) submissions. Letter of Access (LoA) of CEP, received from EDQM ...

Freyr helps in Active Substance Master File (ASMF) compilation, review and submission to all the EU countries with specific submission procedures for all the types of API (manufactured by chemical/Fermentation/ biological/sterile)/drug Substance. Filing Active Pharmaceutical Ingredient (API) information with the European Union (EU) Health Authorities (HAs) is not mandatory. However, to maintain confidentiality and to refer for multiple Marketing Authorization Applications (MAAs), API manufacturers, as a practice file the information in Common Technical Document (CTD) format either as Active Substance Master Files (ASMFs) through any of the EU filing procedures (CP/NP/DCP/MRP) or as a Certification of Suitability (CEP) with the European Directorate for the Quality of Medicines and HealthCare (EDQM). Once API information is filed with the HA and the same is accepted, the ASMF can be referred through a Letter of Access (LoA) to multiple MAAs in order to avoid duplication. Regulat...

Freyr supports in MAA Submissions , registration & life cycle management (LCM) of biosimilar/biological medicinal products and helps in Compiling, reviewing and submission of Variations such as Type IA/Type IAIN/Type IB/Type II in EU countries. Anticipated patent expiry for the blockbuster biological medicinal products attracted most of the Biopharmaceutical companies to develop Biosimilars for global markets including European Union (EU) countries. While registering marketing authorization applications (MAA – Article 10(4) Applications) for those Biosimilars, companies must ensure that the applications are in line with legal requirements and procedures laid down in Directive 2001/83/EC and in Regulation (EC) No. 726/2004. MAAs of Biosimilars must be submitted through Centralized Procedure (CP) and are subjected to the European Medicines Agency’s (EMA’s) evaluation. Even though Biosimilars Regulatory submission pathway facilitates certain advantages for product development and...

Freyr assist pharma manufacturers in IMPD submission for innovator medicinal products, provides professional advice to appoint qualified person (QP) for Good Manufacturing Practices (GMP), supports in compilation and submission of updates/amendments to IMPDs. An Investigational Medicinal Product (IMP) is a pharmaceutical form of an active substance which is to be tested / to be used as reference in a clinical trial. The Investigational Medicinal Product Dossier (IMPD) is a support document providing information on the quality, manufacturing and control of the IMP, non-clinical studies conducted with the IMP, clinical use of the IMP, and the overall risk / benefit assessment of the IMP in the proposed trial. An IMPD is one of the essential documents that form the clinical trial application (CTA) submitted to competent authorities of EU member states for non-authorized IMPs. Where an IMP is subject of a marketing authorization, the Summary of Product Characteristics in addition to ...

Freyr helps pharma manufacturers in filing Market Authorization Application (MAA) License renewal , PSUR Submissions as per HAs requirement for EU by Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP) & Centralized Procedure (CP) A marketing authorization (MA) granted by European Union (EU) competent authority is usually valid for 5 years. If the manufacturer willing to continue, marketing authorization holder (MAH) will have to renew the MA Application (MAA) License by filing renewal application to MAA in accordance with Article 24 of Directive 2001/83/EC and Article 14 (1-3) of Regulation (EC) No 726/2004. The renewal application shall be submitted to competent EU member state’s Health Authority (HA) by MAH at least 9 months before its expiry and failing to which, the validity of MA will lapse. Once the MAA is renewed, it shall remain valid for lifetime, unless the competent authority of EU member state decides to have one more renewal based on pharmacovigilance...

Freyr support MAA Post Approval Submission s of Generic Medicinal products for EU member states to maintain the Regulatory compliance as per HAs by filing Variations and helps in streamlining the changes in formulation & Post-approval activities. After a marketing authorization application (MAA) is granted approval in European Union (EU), in view of commercialization of a product (minimize costs, time or other reasons), the manufacturer may consider making necessary changes. Such changes must be notified to the Health Authorities (HAs) by proposing a Post-approval change submission. As per the guidance, any changes proposed to the registered content in MAA shall be informed to HAs by filing Variations. Based on the impact of changes on quality of the medicinal product, they are categorised as: Major Changes: Have substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product / drug substance as these factors may relat...

Freyr helps Generic medicinal product manufacturers in preparation of product development report and supports  Centralised Procedure (CP)  to obtain a  marketing authorization (MA)  for medicinal products for all European Union (EU) member states (RMS &CMS). Centralised Procedure (CP) is commonly used to obtain a marketing authorization for medicinal products. CP is valid for all European Union (EU) member states. Ever since its induction in 1995, CP has been compulsory for all medicinal products, manufactured using biotechnological processes orphan medicinal products human products containing new active substance which were not authorized in the community before 20 May 2004 (date of entry in to force of Regulation (EC) No 726/2004) which are intended for the treatment of AIDS, Cancer, Neurogenerative disorder or Diabetes. CP is optional for: products containing new active substances not authorized in the community before May 20, 2004 products whic...

Freyr support pharma manufacturers in MAA submission for generic medical product submissions through Decentralized Procedure (DCP) to all selected EU member states (RMS & CMS) as per the regional Health Authorities (HAs) If a market authorization applicant is not granted authorization by any of the European Union (EU) member states, and is aiming for procuring authorization in multiple selected EU member states, then they can approach the Health Authority (HA) through Decentralized Procedure (DCP). The applicant can request any one of the EU member states to act as reference member state (RMS) and submit the market authorization application (MAA) to all selected EU member states (RMS and concerned member states [CMS]). The review cycle for the approval of MAA would be about 210 days, including a 30-day national phase to translate the product information in regional language. Know more at Freyr Page -  Decentralized Procedure (DCP)

Freyr supports Mutual Recognition Procedure (MRP)/Repeat Use Procedure (RUP) to procure authorization of medicinal products in multiple EU member states (CMS & RMS) & helps in compilation, technical review, finalization and publishing for MAA Submissions as per EU regulations. Market authorization holder (MAH) who already has authorization for medicinal product in a member state of European Union (EU) can choose Mutual Recognition Procedure (MRP) in order to procure authorization in multiple EU member states. In this case, the EU member state, which has granted the authorization for the medicinal product, acts as reference member state (RMS) and other EU member states to which the marketing authorization application (MAA) to be submitted for same medicinal product shall be considered as concerned member states (CMS). After MAA submission to all EU member states (RMS & CMS), the assessment report of RMS acts as the basis for other member states to grant the authorizat...

Freyr helps in market authorization application (MAA) submissions by National Procedure (NP) & appointing Qualified Person (QP) for quality and QP for Pharmacovigilance (QPPV) in respective EU member states (concern member state [CMS] or reference member state [RMS]) If an applicant aims to procure a marketing authorization (MA) in a chosen European Union (EU) member state, it is required to submit market authorization application (MAA) to the respective state’s competent authority through National Procedure (NP). The competent authority is responsible for reviewing and granting MA. Most of the Health Authorities (HAs) require 210 days for review and approval of MAA, however it may vary slightly from HA to HA of different member states followed by national phase for translation activities. If an MA is granted by competent authority of EU member state and the applicant would like to register the medicinal product in any other EU member state, MA holder can file the same MAA ...

Freyr helps generic medicinal product manufacturers in handling Market Authorization Application (MAA) submissions with Article 10(1) requirements to HAs in EU by all procedures such as National Procedure (NP), Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP) & Centralized Procedure (CP). A medicinal product, which has the same qualitative and quantitative composition of ingredients, same pharmaceutical form as that of reference medicinal product (RMP) as per the Directive 2001/83/EC Article 10(2)(b) and exhibits bioequivalence with the RMP shall be considered as generic medicinal product. Market authorization holder (MAH) of generic medicinal product should follow the EU guideline Article 10(1) of Directive 2001/83/EC for the registration in European Economic Area (EEA). The key advantage for the MAH is that they are not required to perform and include non-clinical and clinical studies in market authorization application (MAA) as safety and efficacy of the pro...