1. Regulatory Affairs and Compliance

Our Regulatory Affairs services ensure that products meet the legal and scientific requirements of each authority. Key offerings include:

Regulatory Strategy Development:

• We assist with the development of tailored strategies for product registration, market entry, and lifecycle management across SAHPRA, BOMRA, EMA, FDA, and other African authorities (e.g., Zimbabwe’s MCAZ, Nigeria’s NAFDAC, or ZAZIBONA collaborative frameworks).

• Assess regional requirements and harmonised standards (e.g., ICH, WHO, African Medicines Regulatory Harmonisation).

• Provide gap analyses to align product development with regulatory expectations.

Product Registration and Submission:

• Prepare and submit dossiers in compliance with SAHPRA’s Common Technical Document (CTD/eCTD) format, BOMRA’s registration requirements, EMA’s centralised/decentralised procedures, and FDA’s New Drug Application (NDA)/510(k) pathways.

• Support registration of medicines, medical devices, in vitro diagnostics (IVDs), and complementary medicines, including veterinary products where applicable.

• Ensure compliance with SAHPRA’s Medicines and Related Substances Act (Act 101 of 1965), BOMRA’s Medicines and Related Substances Act, EMA’s Regulation (EC) No 726/2004, and FDA’s Code of Federal Regulations (CFR) Title 21.

Regulatory Intelligence and Updates:

• Monitor and interpret evolving regulations, guidelines, and policies from SAHPRA, BOMRA, EMA, FDA, and other African authorities.

• Provide clients with real-time updates on regulatory changes, such as SAHPRA’s amendments to medical device regulations or BOMRA’s January 2025 medical device registration scope.

• Facilitate compliance with harmonised African initiatives like ZAZIBONA for streamlined regional approvals.

Liaison with Regulatory Authorities:

• Act as an intermediary to facilitate communication, respond to queries, and resolve issues during the review process.

• Support pre-submission meetings, inspections, and audits by SAHPRA, BOMRA, EMA, or FDA.

Labelling and Packaging Compliance:

• Ensure product labelling, packaging, and promotional materials comply with regional requirements, such as SAHPRA’s labelling guidelines, BOMRA’s quality and safety standards, EMA’s Annex XIII, and FDA’s 21 CFR Part 201.

2. Quality Management Systems (QMS)

A robust QMS is critical to ensure product safety, efficacy, and quality, as mandated by SAHPRA, BOMRA, EMA, and FDA. Our services include:

QMS Development and Implementation:

• Design and implement QMS compliant with ISO 13485 (medical devices), ICH Q10 (pharmaceutical quality systems), SAHPRA’s quality guidelines, BOMRA’s quality standards, EMA’s GMP (EudraLex Volume 4), and FDA’s 21 CFR Part 820.

• Establish procedures for document control, risk management, change control, and deviation management.

Good Manufacturing Practice (GMP) Compliance:

• Conduct GMP audits and gap assessments for manufacturing facilities to ensure compliance with SAHPRA, BOMRA, EMA, and FDA standards.

• Provide training on GMP requirements, including cleanroom standards, process validation, and equipment qualification.

• Support licensing of manufacturers, wholesalers, and distributors as required by SAHPRA and BOMRA.

Quality Risk Management:

• Implement risk-based approaches per ICH Q9 to identify, assess, and mitigate quality risks throughout the product lifecycle.

• Develop risk management plans for medical devices as per ISO 14971, aligning with SAHPRA, EMA, and FDA expectations.

Supplier and Vendor Qualification:

• Audit and qualify suppliers of active pharmaceutical ingredients (APIs), excipients, and raw materials to meet SAHPRA’s API licensing requirements, BOMRA’s quality standards, and EMA/FDA supplier oversight rules.

3. Clinical Development and Trials
Clinical trials are a cornerstone of product development and regulatory approval. Our consulting services include:

Clinical Trial Strategy and Management:

• Design clinical trial protocols compliant with SAHPRA’s clinical trial guidelines, BOMRA’s regulatory requirements, EMA’s Clinical Trial Regulation (EU No 536/2014), and FDA’s 21 CFR Part 312.

• Support site selection, ethics committee submissions, and trial monitoring in South Africa, Botswana, and other African countries.

     Regulatory Submissions for Clinical Trials:

• Prepare and submit clinical trial applications to SAHPRA, BOMRA, and other African authorities, ensuring alignment with national medicines policies.

• Navigate EMA’s Clinical Trials Information System (CTIS) and FDA’s Investigational New Drug (IND) processes.

     Data Management and Biostatistics:

• Provide data management, statistical analysis, and reporting to meet regulatory standards for safety and efficacy.

• Ensure compliance with Good Clinical Practice (GCP) as per ICH E6 and regional requirements.