Pharma Consultancy

Strategic Regulatory Services

  • Marketing Authorization Application (MAAs): Preparing and submitting dossiers for new pharmaceutical, medical device and nutraceutical products. We understand and adhere to global standards as well as the local and regional regulatory requirements.
  • Variations and Post-Approval Changes: We manage amendments to existing approvals (manufacturing site, labelling update, formulation changes, manufacturing process modifications), to ensure compliance and minimal disruptions.
  • Clinical Trial Applications (CTAs): We support the design and submission of clinical trial protocols, coordinate to get the Ethical Review Board approvals and ensure alignment with Good Clinical Practices (GCP).
  • Pharmacovigilance and Safety Reporting: We manage adverse event reporting, risk management plans, and post marketing surveillance to meet post-approval regulatory obligations and safeguard patient safety.

Commercial Services:

  • Sales and Account Management: Field Sales (Medical Representatives), Key Account Management (KAM), tender Management and distributor & Wholesaler Relations.

  • Marketing & Brand Management: Product & Brand Management, Market Research & Intelligence, Digital Marketing (using CRM platforms), Promotional Material Development.

  • Medical & Scientific Communication: (Commercial-Medical Interface): Medical Education Initiatives, KOL (Key Opinion Leader) Engagement, Scientific Publications & Evidence Dissemination.

  • Market Access & Pricing: Health Economics & Outcomes Research (HEOR), Reimbursement & Pricing Strategy, Public Policy & Advocacy.

  • Commercial Excellence & Strategy: Sales Force Effectiveness (SFE), Training & Capability Building, Territory Planning & Performance Analytics.

  • Support Services: Supply Chain Coordination, Pharmacovigilance, compliance & Regulatory Liaison:

Patient Support Services:

  • Patient Support Programs (PSPs): Offering personalized assistance, including medication adherence tools, nurse support, and educational resources to empower patients throughout their treatment journey.
  • Special Access and Affordability Programs: Facilitating access to high quality medications through expedited special importation license submissions for unapproved medication, liaison to pharmaceutical importers and pharmacies.
  • Patient Engagement and Communication: Utilizing digital platforms, such as mobile apps and telehealth, to deliver tailored outreach, track patient progress, and provide ongoing support.
  • Disease Management Support: Providing holistic resources, such as lifestyle guidance and psychosocial support, to complement pharmaceutical therapies and improve quality of life.

Our patient services are designed to foster trust, enhance treatment outcomes, and align with the industry’s shift toward value-based, patient-centred care.

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Strategic Regulatory Services

  • Marketing Authorization Application (MAAs): Preparing and submitting dossiers for new pharmaceutical, medical device and nutraceutical products. We understand and adhere to global standards as well as the local and regional regulatory requirements.
  • Variations and Post-Approval Changes: We manage amendments to existing approvals (manufacturing site, labelling update, formulation changes, manufacturing process modifications), to ensure compliance and minimal disruptions.
  • Clinical Trial Applications (CTAs): We support the design and submission of clinical trial protocols, coordinate to get the Ethical Review Board approvals and ensure alignment with Good Clinical Practices (GCP).
  • Pharmacovigilance and Safety Reporting: We manage adverse event reporting, risk management plans, and post marketing surveillance to meet post-approval regulatory obligations and safeguard patient safety.
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Commercial Services:

  • Sales and Account Management: Field Sales (Medical Representatives), Key Account Management (KAM), tender Management and distributor & Wholesaler Relations.

  • Marketing & Brand Management: Product & Brand Management, Market Research & Intelligence, Digital Marketing (using CRM platforms), Promotional Material Development.

  • Medical & Scientific Communication: (Commercial-Medical Interface): Medical Education Initiatives, KOL (Key Opinion Leader) Engagement, Scientific Publications & Evidence Dissemination.

  • Market Access & Pricing: Health Economics & Outcomes Research (HEOR), Reimbursement & Pricing Strategy, Public Policy & Advocacy.

  • Commercial Excellence & Strategy: Sales Force Effectiveness (SFE), Training & Capability Building, Territory Planning & Performance Analytics.

  • Support Services: Supply Chain Coordination, Pharmacovigilance, compliance & Regulatory Liaison:

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Patient Support Services:

  • Patient Support Programs (PSPs): Offering personalized assistance, including medication adherence tools, nurse support, and educational resources to empower patients throughout their treatment journey.
  • Special Access and Affordability Programs: Facilitating access to high quality medications through expedited special importation license submissions for unapproved medication, liaison to pharmaceutical importers and pharmacies.
  • Patient Engagement and Communication: Utilizing digital platforms, such as mobile apps and telehealth, to deliver tailored outreach, track patient progress, and provide ongoing support.
  • Disease Management Support: Providing holistic resources, such as lifestyle guidance and psychosocial support, to complement pharmaceutical therapies and improve quality of life.

Our patient services are designed to foster trust, enhance treatment outcomes, and align with the industry’s shift toward value-based, patient-centred care.