MEDICAL UMBRELLA

Scientific, clinical, medical communication, evidence, and commercial-medical functions

A. Medical Affairs & Scientific Strategy

• Medical affairs strategy development

• KOL mapping and engagement planning

• Scientific communication strategy

• Medical launch excellence

• Medical information systems & query management

• MSL training & capability building

• Real-world evidence (RWE) program design

• Evidence generation planning

• Medical monitoring advisory support

B. Clinical Development & Drug Development Support

• Pre-clinical strategy guidance

• Clinical development plans & protocol design

• Endpoint selection & comparator strategy

• Risk-based monitoring strategy

• Trial feasibility and site selection

• Biostatistics & data management advisory

C. Medical Communication & Content Excellence

• Medical writing (clinical, regulatory-linked, safety, HEOR)

• Scientific content development

• Promotional and non-promotional content

• MLR review support (medical review component)

• Publication planning & manuscript support

• Digital scientific assets (MOA videos, e-learning, scientific platforms)

D. Market Access, Pricing & HEOR (Medical-Scientific Portion)

• HEOR modelling (cost-effectiveness, budget impact)

• Value story development & clinical narrative

• AMCP/GVD value dossiers (scientific portion)

• Clinical components for payer communication

E. Digital & AI (Medical-Focused Solutions)

• AI-driven literature screening

• AI-assisted medical writing

• Digital clinical trial tools (ePRO, remote monitoring)

• Data analytics dashboards for medical insights

REGULATORY UMBRELLA

Regulations, compliance audits, approvals, quality systems

A. Regulatory Affairs & Strategy

• Regulatory pathway assessment (FDA, EMA, CDSCO, MHRA, PMDA)

• Dossier preparation: IND, NDA, BLA, ANDA, CTA, variations

• Labelling strategy, safety language, prescribing information

• Regulatory intelligence (global updates monitoring)

• Safety communication & REMS support

• Regulatory strategy for product lifecycle

B. Pharmacovigilance

• Periodic safety report support (DSUR, PBRER writing – regulatory component)

• Safety governance structures

• PV system audits & compliance checks

• Signal detection framework advisory

LEGAL UMBRELLA

IP, compliance, ethics, contracts, and legal-risk domains

A. Intellectual Property (IPR) & Patent Strategy

• Patent search & prior art evaluation

• Freedom-to-operate (FTO) analysis

• Patent drafting assistance

• Lifecycle management (patent term strategies)

• Brand protection and infringement risk assessment

B. Compliance, Ethics & Legal Governance

• Ethics & compliance framework development

• Anti-bribery, anti-corruption advisory

• Data integrity compliance (legal risk component)

• Contractual risk assessment

• Policy development & SOP legal validation

C. Corporate & Strategic Legal Advisory

• M&A due diligence (legal risk side)

• Business contracts, licensing & partnership evaluations

• IP clauses assessment in collaborations

• Legal aspects of technology transfer agreements

D. Digital & AI (Legal/Safety Governance)

• Data privacy compliance (GDPR, HIPAA equivalents)

• Legal oversight of AI-based systems

• Contractual risk in digital/AI vendor selection

We offer tailored IPR solutions for your unique needs, ensuring compliance and support in the Biopharmaceutical, MedTech and Healthcare sectors.

At LEELAWMED, we specialize in providing comprehensive Pharmaceutical Intellectual Property Rights (IPR) and Medicolegal consultancy services, with a focus on patent protection. With decades of expertise in the pharmaceutical sector, our team understands the complexities of patent law and its critical role in safeguarding innovations. We assist clients in obtaining, managing, and defending their patents, ensuring that their intellectual property remains protected in a highly competitive market.

Our services extend beyond patent filing; we also offer strategic guidance in navigating patent litigation, licensing agreements, and patent portfolio management. We work closely with pharmaceutical companies, university researchers, and healthcare providers to ensure that their discoveries are legally protected, allowing them to focus on innovation and growth.

With a deep understanding of the evolving regulatory environment, we provide tailored solutions that address both local and international patent challenges. Our medicolegal expertise helps clients navigate the intersection of law, ethics, and healthcare, offering risk mitigation strategies in the development and distribution of pharmaceutical products.

Trust “Leelawmed” to be your strategic partner in managing pharmaceutical / healthtec patents, safeguarding your innovations, and ensuring compliance with global standards.

Consulting Solutions

CONNECTING THE DOTS UNDER ONE NETWORK .....WITH EXPERTS FROM DIFFERENT DOMAINS.

We understand the dynamic needs of our clients, whether they are startups forging a growth path or established enterprises safeguarding their assets. With a steadfast focus on quality and efficiency, we are here to ensure that your business operates with the highest levels of integrity and compliance.

Medical, Legal & Regulatory Compliance 

Leelawmed offers specialized Medical Affairs services tailored to the pharmaceutical, biotech, health-tech, and medical device sectors. Our multidisciplinary team ensures that your medical strategies align with regulatory standards and industry best practices.

• Our offerings include:

  • Development and review of Patient Information Leaflets (PILs), Summaries of Product Characteristics (SmPCs), and Prescribing Information (PI).

  • Clinical evaluations and risk assessments to support product safety and efficacy.

  • Medical-Legal Reviews (MLR) for promotional materials, labelling, and clinical trial documents to ensure compliance with regulatory requirements.

• Medical Writing Services

  Our expert medical writers produce high-quality, evidence-based content to support both commercial and non-commercial needs:

  • Commercial Medical Writing: Creation of promotional materials, website content, and educational resources that effectively communicate product benefits while adhering to regulatory guidelines.

  • Non-Commercial Medical Writing: Development of scientific manuscripts, clinical study reports, and educational materials for healthcare professionals and patients.

• Intellectual Property Rights (IPR) & Patent Services

  Protecting your innovations is paramount. Leelawmed provides comprehensive IPR services to safeguard your intellectual assets:

  • Patentability assessments and strategic patent filing across multiple jurisdictions.

  • Trademark registration and protection to establish and maintain brand identity.

  • Copyright registration and content licensing to protect original works and manage usage rights.

  • Plagiarism detection and prevention strategies to maintain content integrity.

• Trademark Information Services

  Our trademark services are designed to help you navigate the complexities of brand protection:

  • Comprehensive trademark searches to identify potential conflicts.

  • Assistance with trademark application and registration processes.

  • Monitoring and enforcement services to protect against infringement.

  At Leelawmed, we combine scientific expertise, legal precision, and regulatory insight to deliver tailored solutions that meet your unique needs.

Tailored biopharmaceutical, medicolegal, and healthcare solutions for domestic and international clients.

We don’t just provide services; we build relationships.

Our clients are our partners, and your success is our success.

Thank you for placing your trust in us. We look forward to supporting you in achieving your goals and advancing innovation in the healthcare and legal domains.