At Alcare Consultancy, we provide end-to-end regulatory support for pharmaceutical products, medical devices, food products, nutraceutical’s, and cosmetics. Our regulatory services are designed to ensure compliance with local, regional, and international standards, enabling our clients to achieve timely market access and maintain product integrity.
1. Profiling-
Understanding the client and product
We gain a comprehensive understanding of the clients’s business, products, and regulatory needs. Objective being a detailed client and product profile to guide regulatory strategy.
What we do
- We conduct in-depth consultations with the client regulatory challenge (e.g., product registration, GMP?GDP compliance, pharmacovigilance obligations) to understand their objectives and product lines
- Understand the client’s regulatory challenge (e.g., product registration, GMP?GDP compliance, pharmacovigilance obligations)
- Gather client information (product portfolio and intended markets).
- Understand client’s product type (Pharmaceuticals, medical devices, food/Neutraceutical, cosmetics)
- Classify the product accurately (e.g. medicines, medical devices, cosmetic, food supplement), which determine applicable regulatory pathways.
- Review existing registrations, approvals, or market history
- Identify applicable local, regional, and international regulatory requirements (regulations, guidelines, and authority requirements (e.g. TMDA, TBS, EAC, SADC, AMA)
- Assess potential challenges such as local regulatory restrictions, labeling issues or market -specific requirements
- Define scope and compliance objectives
2. Planning:
Designing the regulatory strategy
We establish a structured road-map for achieving regulatory approval efficiently. The objective is regulatory action plan aligned with business objectives and compliance standards
What we do
- Identify the appropriate regulatory pathways (new registration, variation, renewal, fast-track approval, reliance pathways or harmonized pathways).
- Define timelines, critical milestones, and resource allocation
- Developclear regulatory roadmap with timelines
- Identify potential risks to anticipate regulatory hurdles and device mitigation strategies
- Agree on deliverable s and milestones with the client.
- Allocate responsibilities (client vs consultant)
3. Preparation -
Compiling and Organizing Documentation
We assemble high-quality, complete, and compliant regulatory dossiers in line with authority requirements. The objective being a fully prepared, submission-ready dossier that minimizes regulatory queries.
What we do
- Collect, review and compile required data (dossiers, submission documentation)
- Ensure documentation meets local and international regulatory standards (e.g. CTD format for pharmaceuticals
- Collect technical documentation (CTD, dossiers, GMP, stability data, labeling).
- Conduct gap analysis to identify missing or incomplete data to ensure documentation meets regulatory formatting and quality standards for submission
- Translate documents if required
- Conduct internal quality checks and regulatory compliance verification
- Draft missing documents (SOPs, reports, summaries).
- Ensure compliance with regional/international standards.
4. Processing -
Submission and interaction with regulatory Authorities
We efficiently submit applications and manage regulatory communications in a transparency and well-documented interactions.
What we do
- Submit applications, dossiers, or notifications to the appropriate regulatory authority (TMDA, TBS, EAC, SADC, AMA)
- File dossiers/applications to relevant regulatory authorities (TMDA, TBS, WHO, SADC, etc.).
- Track submissions status and follow regulatory timelines and maintains deadlines
- Liaise with regulatory authorities throughout review process
- Coordinate responses promptly deficiency letters (queries), questions, or additional data request from authority.
- Facilitate direct communication between the client and regulatory agencies to prevent delays.
- Maintain transparent communication with the client and regulators.
- Coordinate inspections and audits for GMP and Audit compliance
5. Post-Approval-
Ensuring Compliance and Market Access
We support our clients after approval and ensure sustained regulatory compliance through smooth product launch and continued compliance in the market.
What we do
- Secure regualtory approvals (marketing authorization, registration certificates, GMP/GDP licenses, import permits)
- Manage approval letters, licenses, or certificates
- Provide guidance on product launch regulatory compliance (like advertisement/promotion materials approvals, packaging and labeling, distribution)
- Verify compliance conditions attached to approvals
- Monitor ongoing regulatory obligations such as renewals, product variations, and
- Maintain registration status, post approval changes/update (renewals, variations), and life-cycle management
- Advice on Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) Adherence.
- Provide guidance on recall management or product complaints handling if needed
- Ensure ongoing regulatory intelligence and compliance monitoring
6. Pharmacovigilance & Compliance -
Maintaining Safety and Regulatory Integrity
We ensure long-term product safety, and regulatory compliance, and market trust through sustained compliance, minimized risks, and enhanced product safety reputations..
What we do
- We set up and manage pharmacovigilance systems for adverse event reporting, signal detection, and periodic safety updates reports
- Conducts regulatory audits, compliance checks, and risk-based assessments
- Establish safety monitoring systems (Pharmacovigilance and safety reporting (ADR reporting, PSURs, RMPs)).
- Keep our clients informed on regulatory intelligence involving regulatory requirements (news laws, guideline changes, harmonization initiatives or safety alerts)
- Train client teams to understand their compliance obligations and best practices for regulatory compliance
- Monitor compliance with GDP, GMP, PV requirements.
