MakroCare IDMP | Identification of Medicinal Product.
Makrocare consulting service is carefully designed to serve all the aspect of IDMP requirement and fully capable to scale up once final implementation guidelines are released. Our long experience in Regulatory Affairs and keen follow up with development of ISO IDMP standards along with EMA /HMA guidelines have given us enough confidence and expertise for formulating strategy for our clients.
As we all know that scope of ISO IDMP is extremely vast and requires expertise not just in regulatory affairs domain but other areas as well keeping this important aspect in mind we have deliberately formed a team of specialist from various domains such as regulatory affairs, IDMP, clinical, manufacturing, supply chain, packaging & labeling, pharmacovigilance, CMC and RIM. This gives us an edge in dealing with all the issues at hand and helps meeting time lines.
Challenges: Makrocare has been very closely monitoring and capturing issues companies facing even to kick start the dialogue of IDMP, initial analysis or creating a road map for their strategy.
Not clear mandate from Management is one issue which affects the overall strategy development. Teams are not clear about budgeting, expenses, responsibilities and domain expertise which put the company in very vulnerable path towards implementation.
Technical challenges are most crucial pertaining to ISO IDMP strategy formulation as final guideline is still not available and whatever information came from authorities if not taken seriously and decisions are not taken on right direction, it would certainly lead to last minute CRUNCH and lots of rework. Companies are not completely clear if they need to upgrade their software systems, if their xEVMPD compliance is enough for upgrading to IDMP and most importantly lack of domain expertise results in waste of resources, time and money.
Confusion in roles and responsibilities happen as generally people have conception that IDMP is sole responsibility of regulatory affairs department and they leave everything upon them. On the contrary RA teams feel inadequate as information required is beyond the reach of RA. This again leads to stress, waste of time and ultimately higher cost.
Inadequate resources is one major challenge companies are facing as preparing for ISO IDMP requires dedicated team of specialists and not every company can lend their already burdened resources to new projects. This leads to resource crunch in terms of both expertise and headcount. Another major factor is that companies find themselves inadequate in resource planning because they are unable to extrapolate complete requirement.
Operations consulting: EMA/HMA guideline for IDMP may not have been out however organizations need to prepare themselves towards IDMP implementation as preparedness is equally important and crucial for right and timely implementation. We help our clients in spreading awareness at management and stakeholder level to give them insight about the regulation and its implication; this helps them to create a high level strategy for their budgeting and resource planning.
Next we help our clients in gap analysis which enables them to understand their current status so that they can devise a very well thought out plan. Our engagement extends to preparing clients for risk analysis and data analysis. Once this is done we help our clients formulating final strategy in terms of resource planning and vendor selection (If applicable)
Technical Consulting: We have been carefully following all the publications, meetings and document releases from EMA/HMA and our technical team has carefully studied and devised strategies to manage actual implementation as well as preparation matrices. We have domain experts who specialize in all five ISO standards thus every detail is well covered.
Apart from this we have software experts to give most cost effective and apt advice related to your existing system and required updates or changes. Along with it we have domain experts who look into your various departments and give advice related with required data.
Quality management:Makrocare quality team is dedicated to devise strategies for quality system maintenance and implementation. They focus to customize strategies to fulfill quality and regulatory requirement and to formulate and implement ISO/GLM/GMP strategies.
Development of SOPs and management of QC/QA are their major focus. Their hands on experience result in prompt problem solving and quick troubleshooting of data and/or process issues. In case of quality deviation and gap or deviation from standard procedure they extend immediate corrective and preventive measures.
- Timely help:Time is ticking fast and if you don’t take decision now , it may immensely cost you in later stage. Hence it is paramount to take right decisions now. Taking our resource help will immediately put you in right direction and expedite the whole process to achieve the set deadline.
- Advance expertise: We believe in quality and make sure that every resource presented to client is well qualified and does the work above expectation. We strive to build our team of experts who works towards greater benefit of clients
- Cost effective: We have developed solutions which carry greater advantage and lower costs. Our need based limited period resource solution not just brings down the cost but it also multiplies your capabilities empowers you do more with less.