Medical Device consulting services | Makro Care
                     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 [email protected]