CAPABILITIES

 

API 

The API unit was established in 2008 with an oncology block which is currently under expansion and will reach a capacity of 24 million tone/year. From January 2012, a non-oncology section built on ~ 50.000 sqm will become fully functional.The API manufacturing facilities are fully compliant with EU, FDA and other authorities and has a number of EU and US DMFs and CEP products. 
Research and Development is an integral part of the API unit and its dedicated scientists support both new product development as well as process optimisation.

R&D

The R&D team was established in 2002 and covers all areas of product development from formulation sciences, analytical services, regulatory expertise and support services. The facilities are spread over an area of ~ 57.000 Sq ft. The team has an enviable track record of successful development of generic medicines, high-barrier products and complex generics. 
 

Capabilities:

Formulation development - a team of 50 highly qualified Formulation Scientists with expertise in development of wide range of dosage forms

  • Tablets, Capsules, ER/SR/CR/MR/DR formulations, EVT Tablets, Pellets, Controlled release pellets 
  • Parenterals (Lyophilized & Liquid), Solutions, Suspensions, Emulsions 
  • Topicals (Ointments/creams/eye drops) 
  • New Drug delivery systems (Oral and parenteral) 
  • Excellent capabilities in Development of Cytotoxic & Potent drugs 
  • Handling Special Delivery Systems & Complex Manufacturing processes
  • Scale up in Class 100.000 pilot manufacturing area 
  • Analytical Development - a team of 180 experienced analyst with expertise in:
    • API characterization 
    • Analytical Method Development & Validation 
    • Dissolution Profiling 
    • Impurity Profiling 
    • Stability Study (ICH & Custom Condition) 

The scientists are supported by 60 regulatory personnel with expertise in dossier compilation and additional regulatory procedures compliant to EMA, FDA, ANVISA and other regulatory agencies.

The R&D group developed numerous novel technologies, formulations and processes covered by 27 international patents.

CRO 

Founded in 1999 Accord's clinical research affiliate, is now one of the biggest CROs in India. 
In the last 4 years, the group has acquired 3 CROs, in North America and the EU, and now undertakes clinical research simultaneously across 3 continents. 
Accord operates now 4 sites comprising over 617 beds and has its own dedicated Clinical and Bioanalytical laboratories. It has also performed nearly 5.000 clinical trials, ranging from Phase I – IV and Bioequivalence studies. 
The organisation now has over 550 clinical research employees and has supported over 500 submissions in USA, EU, Canada, Australia.

REGULATORY 

Accord's regulatory team is based in different parts of the globe with it's back office in India.

  • Experienced regulatory affairs professionals located close to market to deliver to market needs.
  • Back office based in India with more than 40 regulatory professionals dealing with pre-approval and post-approval phases of marketing authorisation life cycle.
  • Strong regulatory compliance in back-office as well as in markets.
  • EU team comprises of 12 regulatory professionals, mostly based in EU head-quarters and some in markets.
  • EU team has good track records of completing more than 120 European Procedures in addition to more than 50 national marketing authorisations in short span of 4 years.

MANUFACTURING 

The group operates 2 significant EU cGMP approved manufacturing sites, SEZ and Matoda. Oral solid dose capabilities include Anti-cancer and Immune Suppressants as well as regular tablets and capsules and effervescent and pellet formulations. 
Patenteral capabilities include regular and cyto-toxic solution and lyophilised vials as well as regular and controlled drug ampoules.

Accord operates a regional packaging centre near Cambridge in the UK (supported by our test and release site in Harrow, North London co-located with our Regional Head Office). 

SUPPLY 

Safety stocks of bulk vials, tablets and capsules are held in the regional packaging site along with market specific packaging components to allow the supply chain to rapidly respond to changes in market demand.

QUALITY 

Accord has dedicated Quality Assurance resources based in EU backed with efficient and responsive Quality Assurance teams at plant and corporate levels.

  • 10 dedicated quality assurance professionals in EU
  • Manage quality systems through change control, deviations, incidences, complaints
  • Audited more than 20 API and several excipients manufacturing sites for GMP compliance
  • Ensure GMP compliance through tight controls on several quality elements through trending and tracking them

SALES & MARKETING

Accord healthcare is young and dynamic, unencumbered by historical ways of operating and determined to make a big impact. 

  • We now have commercial activities in over 27 Eurpoean countries.
  • To date we have gained nearly 5,000 marketing authorizations across the European Economic Area.
  • Vertical integration: Our strategy is to be involved in all the aspects of bringing pharmaceuticals to patients, from clinical concept to end user.
  • By owning all steps of the pharmaceutical development and production process, Accord can bring high quality medicines to patients faster, more economically and with great innovation than our rivals.

PHARMACOVIGILANCE 

Our PV Services provides us with all pharmacovigilance requirements across the EU.

  • The Pharmacovigilance team current comprises over 100 dedicated professionals.
  • Accord is enabled to provide European pharmaceutical companies with services to ensure compliance with EU pharmacovigilance obligations.
  • The group's pharmacovigilance activities have extended to over 50 countries and have recently been approved by USFDA, MHRA and AIFA.
  • The group endeavours to provide most updated safety information to patients and healthcare professionals though regular updates in Accord's SmPC and leaflets.