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Our Services

Our team of experts have the experience (20+ years)
and passion to provide the guidance and deliver the service tailored to your needs.

Trust us to deliver excellence and ease at every step.

Our Services

Regulatory Affairs

We assist with New submissions, Variation compilations, Systems & Process, Digital automation/solutions, and are Biologics specialists.
We assist with New submissions, Variation compilations, Systems & Process, Digital automation/solutions, and are Biologics specialists.
  • Orthodox medicines-new chemical entities.
  • Biologicals.
  • Biosimilars and Vaccines.
  • Orthodox Medecines-generics.
  • Complementary medicines.
  • Pre- and Post-Registration submissions.
  • Renewals preparation.
  • New chemical entities, generics.
  • Complementary and alternative medicines (CAMS) and devices PI and PIL creation.
  • Safety and Pharmacovigilance updates of PIs and PILs.
  • PI Translation.
  • Review and compilation of labels for Health Supplements, Complementary Medicines and Cosmetics.

Stability and validation protocols.

Analytical method transfers and verifications.

Process efficiency ( Submission, Registrations, Artwork).

Digital Automation of Processes.

Dossier Conversions from MBR1 and MRF 1 to CTD or eCTD dossiers.

Development of Standard Operating Procedures (SOPs).

Artwork review and approval; Labels (CAMS).

Regulatory due diligence on companies.

Training

Training of Pharmaceutical Sales representatives, students, healthcare personnel on Therapeutic or Disease areas and Product.
Training of Pharmaceutical Sales representatives, students, healthcare personnel on Therapeutic or Disease areas and Product.

Pharmacology.

New products.

Anatomy.

Medical conditions / illnesses.

Physiology.

Project Management

Project Management, Process Mapping/Improvements- Focusing on providing expert assistance in all areas supporting commercialisation of product.
Project Management, Process Mapping/Improvements- Focusing on providing expert assistance in all areas supporting commercialisation of product.
  • Vaccines and Medical devices.
  • Relaunches of products.
  • Product Line extensions.

Project portfolio management.

Project management methodology implementation.

Continuous Process Improvements.

Process mapping.

QA & Auditing

Supporting the achievement of quality related objectives by ensuring that these strategic and compliance-driven arrangements are effectively implemented.
Supporting the achievement of quality related objectives by ensuring that these strategic and compliance-driven arrangements are effectively implemented.
  • Companies.
  • License application and renewals (SAPC, DOH & SAHPRA) for manufacturers.
  • Applicant import/export.
  • Wholesalers and distributors.
  • API manufacturers (Current GMP, GLP, GWP and GCP).
  • Finish products.
  • Specification Development and justifications.

Internal audits.

Narcotic import / export permit applications.

Product Quality Reviews.

Quality Management System.

ISO (9001 and 13485) - Gap analysis.

Standard operating procedures.

Compilation of SMF and/or Quality Manual.

Pharmaceutical development reports.

Medical Services

Assistance on activities focused within a Corporate Medical Affairs space.
Assistance on activities focused within a Corporate Medical Affairs space.
  • Scientific articles.
  • Clinical trial summaries.
  • Consumer website/blog content.
  • Patient information brochures.
  • Press releases.
  • Clinical safety and efficiency.
  • Marketing strategy development.
  • Promotional material creation.
  • Translation and proofreading of artwork and promotional material.

Bioequivalence study reviews.

Clinical motivations in support of product regestration with SAHPRA.

Process development.

Legal Compliance

Legal services offered by a team with expertise of 20 years within Multinational companies ( including Pharmaceutical). Assistance is also offered to Industries outside of the Pharmaceutical Industry.
Legal services offered by a team with expertise of 20 years within Multinational companies ( including Pharmaceutical). Assistance is also offered to Industries outside of the Pharmaceutical Industry.
  • Review templates (i.e. SLAs).
  • General contract review/compilation.
  • Developing regulatory space, & embedding culture, to comply with applicable laws such as POPIA, Competition Law, Medicines and Related Substances Act.
  • Trademark clearance.
  • Registration and Assignment.

Devise and drive the implementation of strong legal policies, procedures and systems.

  • Prevent risks associated with the business practices therefore assisting in resolving critical matters to safeguard the Company’s interest.
  • Review, guidance, and negotiations on funding, equity, & acquisitions agreement.

Corporate and legal governance.

POPIA Compliance.

In-licensing agreements.

Risk management practices.

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Get in Touch

info@l2rpharmamed.co.za

Sandown, Cape Town

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