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Regulatory Affairs

We have the expertise to support you with regulatory consultancy from your product’s development through to commercialisation.

As a flexible outsourcing partner, we can prepare all regulatory documentation (CTDs, DMFs, CEPs, ANDAs and NDAs), develop regulatory strategies and secure and maintain your Marketing Authorisations. We work in partnership with you to submit the initial documentation package and develop variation plans.

As a proactive regulatory affairs partner, we monitor the variation status of every country, and can provide guidance and consultancy for implementation strategies that suit your needs.