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Medical Device consulting services | Makro Care

As a medical device Manufacturer, whatever maybe your business strategy, it needs to be complemented with effective quality, regulatory and clinical strategies for strong successful commercialization.

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Medical Device consulting services | Makro Care

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  1. REGULATORY Services CONSULTING Whether a technical review (like CMC or Dossier due diligence) or hand-holding your first submission with agency meetings or new country strategy or streaming affiliate compliance or your compliance projects like IDMP / UDI, our consulting team either augments your teams or can take a lead of implementation. CONTENT WRITING MakroCare has expert CMC writing experience for several years strengthened by global experts. Whether new applications or change management, MakroCare can lead or augment your CMC efforts. Clinical & non-clinical writing team is both therapeutically aligned and scientifically deep to support initial applications or health authority queries. REGULATORY OPERATIONS Your needs of dossier compilation / conversion, authorization transfers, or paper/electronic publishing will be well managed with either local or regional or global teams by ensuring right quality at right pricing. Life cycle management (post approval) support of your low value products or smaller affiliates can fully be managed by MakroCare as full-service option. LABELING MakroCare supports both in strategy and operations areas. Working with medical / safety leadership, we can guide you in product labeling strategy. From operations perspective, implementation local country specific labeling (LPD/RPI), QC, translation management, label compliance & core label package maintenance. LIFE CYCLE MANAGEMENT Managing the increased load in submissions and getting timely approvals with added burden of post approval submissions related to portfolio of mature products is tedious as any changes pertaining to CMC, Manufacturing, Marketing, Labeling, CMOs and many other changes need to be informed/reported to Health Authorities. IN SOURCING Companies that have short-term peaks or Systems not ready to open for outside partners to access, MakroCare will provide consultants to work onsite with your teams and the models can be FTE or FSP. www.makrocare.com regulatory@makrocare.com

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