bluestock consult
regulatory affairs

Our Services
Regulatory Affairs is the key function of any pharmaceutical or other healthcare business development plan. Knowledge and expertise of the local healthcare regulation is a vital for swift execution and achieving business objectives.

Our regulatory Affairs team assists in drawing the appropriate regulatory strategy, provides knowledgeable assistance in pharmaceutical registrations and associated activities.

Our regulatory Affairs services includes;

Recommendation of regulatory strategy
We handle complex registration procedures of pharmaceutical/biomedical products and devices following structured project management pathway.

Complete package starting from counseling Regulatory Affairs regulations and recommend the appropriate regulatory strategy for your business.

Dossiers recommendations and review
Expert advice upon reviewing dossiers for submission and registration.
Independent and strategic guidance assures successful dossier submission in a timely manner.
Knowledgeable in GCG and European Union standard pharmaceutical CTD dossier delivery.

Products registration service
Expert team of regulatory affairs to ensure successful Pharmaceutical products registration.
Monitoring and liaising with the local Regulatory Agencies.
We keep abreast of local Regulatory Affairs regulations liaison with local Medical, Drug or Regulatory Agencies, or Ministry of Health Departments responsible for MA procedures an effortless endeavor.

Licenses and certificates transfer
Our advisory know-how also includes pharmaceutical licensing. We will assist in evaluating licensing opportunities for license in or Marketing Authorization transfer that are in the center of your pharmaceutical business development plan.

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