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Herbal Products

 

'It is a huge step forward for us and not only have they done such a great job but they have been very professional at all times'

Regulatory Affairs Manager, Northern Europe, International Pharmaceutical Company

 

 

Regulatory Affairs 

Over the past 10 years numerous directives and regulations which cover all aspects of medicines development and licensing have been implemented. How can companies remain competitive and successful in the pharmaceutical and related industries, where there is an ever increasing and changing burden of regulation and requirements as well as a general shortage of skilled and experienced regulatory professionals?

Unicus offers exceptional regulatory professionals, comprising senior managers with between 15 and 28 years experience, who lead highly skilled, dedicated, and flexible teams available to suit your requirements (interim cover, full-time, part-time, working on site or remotely).

Proven track record in providing innovative and cost effective support in all aspects of regulatory work to our partners for over 10 years.

Ability to deliver bespoke regulatory solutions to meet all clients requirements.

  • Management of all EU procedures (MAA & CTA)
  • New drug applications for generic, herbals, biotech and traditional medicinal products
  • Advice on filing strategy
  • Risk assessment for product development plans
  • Expertise in multiple therapy areas
  • Maintenance activities and record management
  • Due Diligence
  • Regulatory Intelligence
  • Submission writing, compilation and publishing
  • Regulatory Training
  • Unicus has successfully partnered 8 out of the 10 top pharmaceutical companies and 5 out of the top 10 biotech companies, and have over 140 clients in total.

     

    "I was extremely pleased with the professionalism and extremely fast service that you and your colleagues at  Unicus provided and I would be very happy working with you on projects in the future."
    Regulatory Affairs Manager.
    Blue chip - Biotec

     

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