CMC Regulatory Services

Reliable Global Regulatory support with Customer-oriented services.

Our Global RA guarantees same level of service and regulatory criteria in all our sites, being able to:

- Respond in a timely manner any questions from customers and Health Authorities.

- Integrate with all operational teams from development to commercial:

  • •  Development Stage and Dossier Preparation

  • •  Definition of the regulatory strategy with customer and Core team members to ensure submission within established timelines

  • •  API Route of Synthesis definition strategy assessment to ensure Regulatory Starting Materials ICH Q11 compliance

  • •  Assessment on sufficiently supported Regulatory Established Conditions

  • •  Assessment on consistency of global control strategy including compliance with ICH Q3D, ICH M7 , EMA and FDA guidance for nitrosamines

  • •  Production of consistent, high-quality, technically valid documents meeting regulatory (PDF) standards

  • •  Able to adapt to customers' templates and requirements

  • •  Issue technical documentation with the local support needed to have our products approved by the authorities (FDA, EDQM, PMDA...). Currently active dossiers: 24 US DMFs (FDA), 15 CEPs (EDQM), 5 CAN DMFs (Health Canada), 6 J-DMFs (PMDA) and 1 C-DMF (CFDA)

SQE Compliance & CMC Regulatory Services
SQE Compliance & CMC Regulatory Services

Revision Stage

Effective response to any deficiencies working with departments involved Commercial Stage.

After approval, impact assessment of any proposed change and relevant dossier update

Minimization of workload peaks for customers (direct access to all the documentation expedite file preparation during all the dossier lifecycle)

Flexible communication to meet customers' needs at customers' own pace and preference (email, telecons, on-site visits)