Makrocare

Regulatory, Clinical Consulting Services to Biopharma & Medical Device Companies – MakroCare

MakroCare offers a comprehensive suite of regulatory and clinical consulting services tailored to the needs of biopharma and medical device companies. Their expertise spans the entire lifecycle of product development, from early-stage research and development to post-market surveillance. The key services provided include:

1. Regulatory Strategy and Consulting:
   • Development of regulatory strategies that align with the specific needs of the product and target markets.
   • Guidance on regulatory requirements and pathways to ensure compliance and expedite approvals.
   • Preparation and submission of regulatory documents to authorities such as the FDA, EMA, and other global agencies.
2. Clinical Development Services:
   • Design and management of clinical trials, including protocol development, site selection, patient recruitment, and monitoring.
   • Data management and biostatistics to ensure accurate analysis and reporting of clinical trial data.
   • Support in the preparation of clinical study reports and regulatory submissions.
3. Quality Assurance and Compliance:
   • Implementation and auditing of quality systems to comply with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and other regulatory standards.
   • Training programs to ensure staff are well-versed in compliance requirements.
4. Regulatory Submissions and Approvals:
   • Compilation and submission of dossiers for Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), and Pre-Market Approvals (PMA).
   • Interaction and negotiation with regulatory bodies to facilitate the approval process.
5. Post-Market Surveillance and Support:
   • Ongoing monitoring of product safety and efficacy through post-market studies and pharmacovigilance.
   • Management of adverse event reporting and product recalls if necessary.
   • Support in the development of marketing and labeling strategies to ensure compliance with regulatory standards.
6. Strategic Consulting:
   • Market analysis and competitive intelligence to inform product development and commercialization strategies.
   • Advice on lifecycle management to maximize the value of the product portfolio.

MakroCare's team of experts combines in-depth regulatory knowledge with practical industry experience, providing biopharma and medical device companies with the guidance needed to navigate the complex regulatory landscape and bring their products to market efficiently and successfully.