Contract Development

Contract Development

A wide range of services

Chromatography and analytical groups perform quality control of medical products, pharmaceutical substances, excipients (among them HPLC and GC methods); develop method analysis of new medical products; validate analytical methods.

Employees of the standardization group prepare registration dossier (including CTD format), develop in-house standards and procedures, and support quality system.

Technology-and-testing laboratory develops composition and technology of new medical products products, validate technological processes, carries out activity on scaling-up.

R&D Laboratory in cooperation with R&D Department perform the following science-research and design-and-experimental activities:

  • Development of composition and technology of new medical products and their further launching into manufacture
  • Transfer of medical products technology to commercial scale
  • Medical products, pharmaceuticals and excipients testing
  • Stability testing of medical products and pharmaceutical substances
  • Development and validation of method analysis of medical products
  • Preparation of registration documents for medical products and pharmaceutical substances
  • Research activities focused on new pharmaceutical products development
  • Support of registration of medicines and pharmaceutical substances and clinical trial authorization.
Contract Development

R&D Laboratory has experience in pharmaceutical development of the below mentioned pharmaceutical forms:

  • Tablets
  • Coated tablets
  • Dispersible tablets
  • Modified release tablets
  • Capsules
  • Suppositories
  • Syrups
  • Emulsions
  • Powders/granules for suspension/oral liquids
  • Oral gels
OTSPHARM
Acino
NC-PHARM
Ниармедик
Р-ФАРМ
Фармстандарт
Космофарм
teva

Execution Timeframes

60days
Development of quality control methods of medical products quality control
60days
Methods of development of medicines quality control
120days
Manufacturing and quality control of pilot batches s of medicines
150days
Organization of industrial production and technical documents preparation
Timeframes of stability investigation are set in accordance with ICH Q1 recommendations.

In 2005, in order to develop, incorporate into manufacturing and register original, safe, effective and high-quality medical products and generics JSC AVVA RUS’s R&D Laboratory (R&D) was founded. JSC AVVA RUS’s R&D is a unique laboratory combining analytical facilities and equipment for pharmaceutical development of medical products. R&D laboratory follows the up-to-date pharmaceutical regulatory documents and quality systems like ICH Quality Guidelines, WHO guidelines; Good manufacturing practice (GMP), ISO/IEC 17025:2005 (National State Standard ISO/IEC 17025-2009) General requirements for the competence of testing and calibration laboratories; National State Standard P 52249-2009 Good Manufacturing Practice for Medicinal Products; Good Manufacturing Practice for Medicinal Products (Order by the Ministry of Industry and Trade of the Russian Federation #916 as of 06/14/2013).

The quality system is implemented within the laboratory and is maintained in accordance with the below mentioned requirements:

SO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories.

Order #682 by the Ministry of Economic Development and Trade as of 10/16/2012 ‘On Approval of the Criteria for Accreditation of the Certification Bodies and Testing Laboratories (Centers) and Requirements to Them’.

National State Standard P 51000.4-2011 General Requirements to Accreditation of the Testing Laboratories.

Key R&D’s objectives:

  • Mastering new types of products. Development of composition and technology of new medicinesmedical products and their introduction into manufacturing
  • Improvement of the existing technological processes. Testing of medicines medical products, pharmaceutical substances, excipients
  • Testing of medicines medical products and pharmaceutical substances stability
  • Development and validation of analytical methods to control medicines medical products quality
  • Preparation of documents for registration dossier to certify new medicines medical products
  • Research work targeted at invention of new pharmaceutical substances
  • Assuring accuracy, objectivity and required efficiency of the results

Quality Assurance

R&D Laboratory provides high quality implementation of the services due to availability of:
Rated experimental and industrial facilities
Full package of up-to-date technological and analytical equipment
Efficient staff with rich experience in development and quality control of medical products

Equipment

In order to accomplish the above mentioned tasks R&D Laboratory applies technological and analytical equipment produced by the leading global manufacturers.

Chromatography and analytical group develops and validate analytical methods for excipients, pharmaceutical forms under development and active pharmaceutical ingredients in compliance with CPMP/ICH/381/95, European Pharmacopoeia and USP.

In order to conduct necessary testing properly. Chromatography group is equipped with up-to-date analytical devices (HPLC, gas-liquid chromatography, dissolution test machines etc.) produced by:

Shimadzu (Japan)
Waters
Agilent Technologies
Millipore (USA)
Pharma Test (Germany)
HPLC devices are equipped with modern multi-channel gradient pumps, autosamplers, analytical thermostat columns and various types of detectors. Flexible modular systems render possibility to develop, validate and reconstruct methods of diverse complexity levels.
Scaling and technology transfer is possible due to the JSC AVVA RUS’s production capacity and also can be moved to the working space of customer with further consultative support by R&D’s personnel.
Standardization group carries out investigation of medical products and pharmaceutical substances stability in different climate conditions (stress-testing, accelerated tests of stability, long-term research, photo-stress study) in accordance with ICH Q1.

Main thermal modes are listed below:
t, C Relative degree of humidity, % Expiry date Place of storage
25±2 60±2 Before expiry date (long-term testing) Arbitrage storage stockroom
30±2 65±2 12 months (midterm testing) Climate chamber YP-720SDP
40±2 75±2 6 months (accelerated testing) Climate chamber KBF-240
Stability testing in the temperature ranges 0 ºС-70 ºС and humidity ranges 10%-80%, stress-testing, photo-stress study. Climate chamber KBF P 240

Climate chamber KBF-240

Climate chamber KBF-240
Climate chamber KBF-240 is used for storage of medical products at set temperature and humidity.

Climate chamber YP-720SDP

Climate chamber YP-720SDP
Climate chamber YP-720SDP is used for storage of medical products at set temperature and humidity.

Personnel

Total number of laboratory employees constitutes 30 people, 27 of them have specialized university degrees. Personnel are experienced in the fields of manufacturing, medical products quality control and analytical chemistry. R&D’s personnel take annual professional course at the leading education centers of Moscow, Saints-Petersburg, Yekaterinburg and other cities and upgrade their professional skills due to regular in-house training in compliance with GMP.

Our partners

We provide contract services on pharmaceutical development for the companies like CJSC R-Farm, Nearmedic Plus Ltd., N.C. Pharmaceuticals Ltd., Functional Products Ltd., Teva Ltd. etc.

Contract Development

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