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Grindeks

Regions
Europe
Countries
Estonia, Latvia, …
Countries
Estonia, Latvia, Russia
Size
n.e.
Specialty
Human Medicines, Biopharmaceuticals
Service category
Contract manufacturing, filling and packaging, Pre-clinical development and testing, pre-clinical CRO, …
Service category
Contract manufacturing, filling and packaging, Pre-clinical development and testing, pre-clinical CRO, Clinical development and testing, clinical CRO, Pharmacovigilance and QPPV services
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Key services

Services


Services

«Grindeks» is a vertically integrated company possessing all necessary resources to perform the entire product development process from early research of medications to registration and sales of the ready-made product.

Key factors to choose «Grindeks» as a co-operation partner:     

  • High international quality standards achieved (GMP, GLP, ISO 9001, ISO 14000) certified by FDA, TGA, Latvian Agency of Medicines, LATAK, APIC , and etc. authorities
  • Powerful knowledge base and experience in the entire life cycle of the project - R&D, marketing, production, registration and sales.
  • Experienced and competent staff
  • New and modern technologies
  • Modern equipment and procedures ensuring the quality according to the international standards,
  • Historically established tight co-operation between the science and the industry in Latvia, Russia and the CIS countries
  • Stable sales network in the Baltic States and CIS countries, cooperation partners all over the Europe and the world.
  • Favourable geographic location of Latvia as a bridge between the Europe and the Russia, which allows saving on logistics costs while shipping the products either to that or this direction.


Research and Development

«Grindeks» has all required resources to ensure research and development of the both active pharmaceutical ingredients and ready-made medications in compliance with the international quality standards at acceptable prices:

  • cGMP, GLP, GCP, eCTD, CTD
  • modern technologies, laboratories and production facilities
  • legal competence
  • 70 highly qualified and competent staff members.


 «Grindeks» succeeded in co-operation with Latvian scientific and research institutes as well as with foreign pharmaceutical companies in fulfilment of a number of scientific projects contributing to new substances research and development.

Research and Development of API

«Grindeks» ensures research and development of active pharmaceutical ingredients in compliance with cGMP (current Good Manufacturing Practice) standards and suggests solutions meeting the specific client demands.

  • LRP certified and API and intermediary products synthesis
  • Specific technologies: lyophilization, electrodialysis, Grignard reaction, catalytic hydrogenation and etc.
  • Complete analytical support - HPLC (including UV, MS, LSD, refractometrical detection), NMR, DSC, PXRD, IR, UV, CHN analysis, Atom absorption, etc. including validation of methods in GMP or GLP certified laboratories.
  • Development and optimization
  • Contract production in accordance with the LRP standards including methods validation and equipment washing validation
  • Stability studies under ICH guidelines
  • Development of active substance master files (ASMF) in CTD
  • Solution of more complicated matters in liaison with the scientists from the Institute of Organic Synthesis, University of Latvia and Riga Technical University


New Active Pharmaceutical Ingredients Analytical Scale-up Laboratory

«Grindeks» offers to do the complicated many-stage (5-10 stage) API synthesis, mainly focusing on the niche pharmaceutical products:

  • Technological  transfer from laboratory-scale volumes (flasks) to industrial volumes (reactors)
  • Analytical research and specification of the substance before commencing the production cycle
  • commercial production in smaller volumes in glass reactors (to 6 kg) and enamelled reactor (to 30 kg)
  • Production is in compliance with the Good Manufacturing Practice standards
  • Entire analytical support of the process (including methods validation) is ensured by:
  • high effective liquid chromatography (ultraviolet, mass spectrometric, air diffusion or refractometric detector)
  • nuclear-magnetic resonance
  • differential scanning calorimetery
  • x-ray diffractio
  • infrared spectroscopy
  • ultraviolet spectrophotometery
  • elementanalysis
  • atomabsorption

Final dosage form development

  • Final dosage form development and manufacturing:
  •  Development of final dosage form technologies and product introduction to manufacturing  
  •  Validation of manufacturing process and analysis methods
  •  Development of drug registration documents in CTD, eCTD in compliance with the EU requirements as well as development of drug registration documents in compliance with the requirements of CIS.
  • Consider patent renewal potential for original products with the expiring patent term
  • Qualitative brand-generic development for original products with the expiring patent term

Registration

«Grindeks» has a wide sales network and great experience in the market as well as all resources necessary to provide contract registration services to meet the clients demands:

1) Packaging development in compliance with the specific legislation of a particular country - we can produce the entire packaging set from the information on the packaging to readability testing of product information leaflet in the Europe and the CIS.

2) Readability testing of product information leaflets

3) Translation of the Drug Registration Documents and adaptation to the particular country market

4) Entire development of drug registration documents in CTD, eCTD in compliance with the EU requirements as well as development of drug registration documents in compliance with the CIS countries requirements

5) Drug registration process steering and co-ordination.

Regulatory Strategy Planning

 

«Grindeks» Regulatory Affairs services include strategic regulatory planning, according to individual client requirements, up to and including liaison of the client to regulatory agencies

Regulatory Submissions and Support

 

Preparation, compilation of dossiers according to European requirements and evaluation of documentation
Development of CTD modules:

  • Preparing of Module 4 & 5 for bibliographical references
  • Preparing of Module 3 for Pharmaco-chemical part
  • Writing Module 2 - Overviews of Pharmaceutical, Preclinical and Clinical Results; Expert Reports

Marketing Authorisation Applications consultancy and specific or full services

Via National Procedure:

  • Translation and comparison of SmPC to originator for generics
  • Translation and labelling of PIL
  • Review and completion of dossiers
  • Compilation of Module 1
  • Liaison with competent authorities
  • Advancing process by the procedures in different countries

 Via Mutual Recognition Procedure (MRP) / Decentralised Procedure (DCP):

  • Application for national MA (MRP part)
  • Translation and comparison of SmPC to originator for generics
  • SmPC harmonisation
  • Translation and labelling of PIL
  • Review and completion of the dossiers
  • Compilation of Module 1
  • Securing the MA (national phase) and applying for the Assessment Report
  • Establishing "day 0"
  • Preparing the Response Volume
  • Steering CMS submissions
  • Liaison with competent authorities
  • Advancing processes by the procedures in different countries

 Variation and renewal applications:

  • Renewal applications of a Marketing Authorisation
  • Type I-II Variation Applications of a Marketing Authorisation
  • Marketing authorisation transfers to a new holder
  • The package leaflets and labelling amendments
  • Packaging material design correction & proofreading

Regulatory Specialisation – Russia, Ukraine, Belarus and other CIS countries
Due to its location, "«Grindeks»" is well placed to provide the following services:

  • Compilation of dossiers according to regional requirements
  • Submission
  • Advancing of the procedure
  • Direction of the process in all of the stated countries
  • Liaison with Russia, Ukraine, Belarus and other CIS countries regulatory authorities

Product information and readability test

Summaries of product characteristics (SPC), product information leaflets (PIL) and labelling:

  • Preparation, translation and updating of texts
  • Packages printing process and package leaflets steering
  • Managing pan-CIS labelling projects

Readability testing of product information leaflets (PIL):

  • Readability tests of package leaflets in accordance with EU directives, especially to the findability, applicability and understandability of text
  • The entire testing from the preparation of the package leaflet up to the Final Report is handled. The issued signed Final Report will confirm that testing both, one by one and altogether has succeeded
  • Interviews, performed by professionals
  • Individually structured test designs; user tested interviews with independent observers and supervisor
  • All events are carefully prepared in close cooperation with the sponsor in accordance with the demographic situation of drug's target (indicated) and/or current actual patient group
  • «Grindeks»" is responsible for all stages of testing, including suggested amendments to the leaflet and test, and for all the listed items below

 Readability tests run for four to six weeks and cover the following areas:

  • Writing the protocol
  • Writing the test questions
  • Preparing the questionnaires
  • Defining the target group
  • Enrolling of volunteers into the target group
  • Checking the questionnaire with a pilot test involving 1-3 patients
  • Performing interviews with at least 20 patients in two separate rounds
  • Performing statistical analyses
  • Correction of the patient leaflet
  • Repeating the interviews
  • Evaluation
  • Writing the summary
  • Preparing the document for submission to the authority
  • Translation of the document into English
  • Loan translation of the approved patient leaflet

Translations, proofreading and editing
Professional translators of «Grindeks» will translate documents related to regulatory affairs: 

  • All parts of a final dosage form dossier
  • Summaries of product characteristics
  • Package leaflets and labellings
  • Authority statements and decisions

 Services in English, Russian, Latvian, German, French, Lithuanian and Estonian.

Manufacturing

Contract manufacturing of various volumes is possible depending on the client's needs:

1. Full spectrum or vertical integration - from API development and manufacture to the development, manufacture, packaging and distribution of finished dosage forms.

2. API manufacturing - production of substances only including development of registration documentation (ASMF).

3. Development and manufacturing of finished dosage forms - development of finished dosage form technology, product manufacturing, validation of the manufacturing process and analysis methods, development of drug registration documentation (CTD, eCTD format in accordance with EU requirements, as well as drug registration documentation in accordance with CIS country requirements).

Contract manufacturing helps bring products to market faster, because companies specialising in contract manufacturing usually perform product development, manufacturing, packaging and delivery within a firm timetable in accordance with the JIT system and GDP requirements.

API manufacturing

«Grindeks» API manufacturing facilities ensure bulk production of substances and intermediary products as well as products scaling.

 The core technologies cover the following types of reactions:

  • Substitution
  • Elimination
  • Addition
  • Regrouping
  • Specialized reactions

 Typical processes for the routine production are:

  • Heating / cooling (from -30° C to +250°C)
  • Autoclave processes (up to 40 tam)
  • Rectification; extraction
  • Crystallization; sedimentation / filtration
  • Distillation in vacuum
  • Saturation with gases
  • Freeze-drying

 Manufacturing scale:

  • Stainless-steel and glass lined jacketed reactors from 250° to 1,600l
  • Autoclave 160l
  • Centrifuges (max load 250kg)
  • Rectification columns
  • Vacuum and pressure filters
  • Shelf and conical dryers
  • Evaporation equipment (10/hr to 50l/hr)
  • Freeze-drying equipment

 Separate production lines and cleaning validation are used to prevent cross-contamination.

Final dosage forms manufacturing

«Grindeks» offers the entire range of finale dosage forms contract manufacturing services, including:

  • procurement of raw materials
  • quality control
  • know-how development
  • product introduction process
  • validation of manufacturing process and analysis methods
  • production
  • packaging
  • logistics

Manufacture can ensure the manufacturing of tablets, capsules and syrups

Tablets:
    Forms – round, oval, with a break groove
    Sizes – diameter from 5 to 12 mm
    Tablet coating is possible (except for sugar coating)
Hard gelatin capsules

  • No. 3, 1, 0, 00
  • Colour options

 Syrups:

  • Production output – 800 000 bottles annually
  • Glass, polymer bottles
  • Volume– 30ml, 100ml, 200ml

Packaging

  • Blistering and packaging
  • PVC, PVCD, ALU blisters
  • 6 to 25 tablets in a blister
  • 10 capsules in a blister

Research and Development

Research & Development (R&D) activities of «Grindeks»are focused on the fulfilment of the yet unachieved pharmaceutical needs. Our goal is to create innovative brand products that could be used for the fulfilment of health care needs in the future.

Every year company allocates significant resources (8-10% of the net sales) in the research and development that are mainly oriented towards following fields – development of cardio vascular, neurological, anti cancer and virus preparations. 4-5 research projects are carried out annually and about 70 employees are involved in the R&D activities of the company.

Currently «Grindeks» is the holder of significant patents in different countries of the world, and company is planning to register numerous new patents.

Research and Development of APIs

The research of active pharmaceutical ingredients is carried out in compliance with the CGMP (Current Good Manufacturing Practice) standarts and specific requests of the clients.

«Grindeks» succesfully co-operates with Latvian scientific and research institutes and with foreign pharmaceutical companies. The focus is on various research projects aimed at study and development of new substances which will be used in the manufacturing of innovative and efficient medications.

Latvia is eligible country for the development of generic active pharmaceutical ingredients therefore every year portfolio of APIs is expanded with at least two new products.

Preclinical trials

Research activities of «Grindeks» are mainly focused towards the development of:

  • cardiovascular medications;
  • neurological medications;
  • anti-cancer agents;
  • antivirual drugs.

Planning and organisation of biomedical pre-clinical trials are performed in the field of the development of new products. In cooperation with the leading scientific research institutions from Latvia and abroad active work is carried out in the development of several new medications. Every year 4–5 research projects are carried out in the company.

Clinical trials

Clinical trials are research studies which try to answer scientific questions and find better ways to treat or prevent diseases. Most clinical trials follow a series of phases.

In cooperation with the leading clinicists, scientific experts and research organisations of European significance «Grindeks»performs ICH/ GCP (Good clinical practise) and clinical trials of I – IV phases corresponding with the state legislation for the brand products of the company.

Pharmacovigilance

In accordance with its responsibility for its products and the health of the consumers, JSC «Grindeks» continues to develop its pharmacovigilance system in all sales markets. For the purpose of elimination of potential risks and health hazards, data on the effects of the medicinal products are being summarised, investigated and evaluated and information about the side-effects and interactions of medicinal products is being gathered.

The analysis of the reports and their further submission to the competent authorities are carried out in accordance with the relevant guidelines and pharmaceutical company practices. «Grindeks» is involved in the electronic reporting system EudraVigilance which is also the main European Risk Management Strategy support between the EMEA (European Medicines Agency) and the competent national authorities.

To ensure control of safe drug administration, there is the Pharmacovigilance group at the company, which key task is to state and timely eliminate adverse/side effects from drug administration and report to the competent authorities.

Please, inform if you have side or adverse effects while administrating «Grindeks» drugs. 

Approvals, Certificates, Authorisations

  • GLP
  • ISO 9001
  • TGA
  • Latvian Agency of Medicines
  • LATAK
  • APIC
  • cGMP
  • FDA
  • GCP
  • eCTD
  • CTD

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