| Regulatory Services - Pharmaceutical Exova Health Sciences provides a full range of analytical and formulation services to the pharmaceutical and biotechnology industries, supported by our regulatory services. Based in Camberley in Surrey, Exova Prova has proven a track record of offering a full regulatory service for all aspects of product licensing. We assist a wide range of clients in their development work specialising in work with a high chemistry and pharmacy content.
Our main regulatory activities include:
- National and European applications including all expert summaries, administration and submission.
- Mutual Recognition and Decentralised Procedures
- Quality Overall Summaries
- CTD Module 3
- Part II to Module 3 Conversions
- Drug Master Files (Applicant’s and/or Restricted Part) plus Quality Overall Summary
- Certificate of Suitability Applications
- Veterinary Part II/Expert Reports
- Assessment/Registration of third party technical dossiers/technical ‘due diligence’
- Product Licence variations and renewals.
We can provide a complete, integrated service from formulation development, through analytical chemistry and stability testing to regulatory MAA submission. Exova Prova have experienced project managers who can assist in guiding your development project through the regulatory mine field.
Companies may require additional support on a short-term basis due to project peaks or absence of key workers. Our staff can become part of the client’s own team providing additional resource or the benefit of an independent opinion either as a named Expert or by reviewing draft submissions.
For further information regarding our specialist services, please email healthsciences@Exova.com or call us on +44 (0)121 206 4120.
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