With today’s constantly changing laws and regulations the need for professionals to help with the launch and lifecycle of products and services is a growing demand. Are companies nowadays preferring to use external providers due to the fast-changing environment?
If you look at the growth of many of the consistently successful organizations, analysis shows it is their ability to predict external changes, adapt to them quickly, and efficiently evolve their products and services. These companies keep repeating this cycle and the duration of the cycle depends upon the business function involved.
In the product safety and regulatory space, the following trends have emerged in recent years:
1. Sustainability – Focus on use of ingredients or materials in products that would significantly minimize adverse impacts on the environment including plants, animals, humans, and the supporting eco-system. The ultimate goal is to remove environmental impact to where the product manufacture, consumption and recycling or disposal is fully sustainable.
2. Evolution of regulations – Societies demand safer products and want to consume products that do not harm the environment. These demands result in the evolution of regulations for chemical and product safety. The challenge for businesses is to remain abreast of all changes happening in key territories and markets.
3. New scientific tools and methodologies minimizes need for generating data through animal tests. This most importantly saves animals, saves effort, and reduces costs.
4. Information and Knowledge management: A typical challenge companies (especially multinational firms) face is not really being 100% sure of what information exists internally, assessing its relevance for a safety assessment or regulatory submission, process of updating or refreshing it periodically, easy retrieval and reuse in future by colleagues in different product line or countries. Those who structure their data right, reusing and refreshing it systematically will have an edge.
Coming back to your other question, are companies preferring to externalize more with providers such as Evalueserve? I think many companies have realized that building capability and capacity in every sphere of business is not the smartest way forward. It is time consuming, cost intensive and ultimately not very efficient. Companies need to have a robust process of identifying right external partners. Some of the factors to consider would be subject matter expertise, relevant experience, flexible business models, agility to adjust to their clients evolving business needs, innovative and futuristic (digital) solutions, and above all proven track record of partnering with clients.
One example of this fast-changing regulations is the implementation of medical device regulation (MDR) in Europe. How do you feel will the industry respond to such new regulations?
MDR should help in bringing clarity and uniformity on all scientific and regulatory aspects related to medical devices including definition of what constitutes a medical device or products in the first place. This major change creates a robust, transparent, and sustainable regulatory framework, recognized internationally, that improves clinical safety and creates fair market access for manufacturers and healthcare professionals.
For compliance with MDR in the short term, the effort and cost involved in with meeting the regulatory need might be higher. However, the trick will be to look at ways to optimize this cost and create an efficient ecosystem of internal and external stakeholders that is agile enough to respond to evolving regulatory changes across markets and countries of interests.
Talking about other regulations, one of the very comprehensive pieces of legislation brought in by European Chemical Agency (ECHA) at the turn of the 21st century was REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). It has provided countries across the globe a comprehensive template to streamline their chemicals regulations in the EU. Now, a similar legislation, India REACH will soon be in force in India, and we are also assisting our clients prepare for it.
What do you see as our core strengths at Evalueserve to support Chemical Safety and Regulatory needs of clients?
Evalueserve has been supporting clients since the last two decades and I would list the following as our strengths:
- We have expertise across the entire value chain of chemicals safety assessment with over 10,000 lit searches undertaken, >2000 hazard assessments in cosmetic, pet care, and household products. We have also assessed numerous botanical ingredient and dietary supplements. Our work includes human and environmental risk assessments, classification and labelling on >1000 chemicals, toxicological profiles, > 300 PIFs and CPSRs and REACH support for over 1500 chemicals
- Implemented quality management systems with well-defined Standard Operating Procedures, periodic audits, quality control mechanisms and robust training programs.
- Evalueserve adapts to new client requirements and co-creates capabilities in an efficient manner.
- Proprietary digital solutions and platform developed by Evalueserve for clients that helps in ease of search and retrieval, reuse and sharing of information. We also have tools developed by our in-house Technology team that brings process efficiency starting from comprehensive literature search to complex safety data summarization.
4. Global team
- We have a global team that provides local language, same time zone support and developing better understanding of local regulations.
5. Flexible engagement model
- Most of our engagements are ongoing continuous relationships. However, we are very well place to meet urgent needs of clients due to agile deployment of resources and cross functional competencies in the team.
And for the final question, tell us about yourself in as few sentences as possible. Additionally, we would love to hear what do you want people to remember about you?
Well, I am a researcher by educational background (PhD in Chemicals) and striving for how best science can help in making our planet even more beautiful and safe place to live for generations to come through sustainable use of scarce natural resources. I am based out of Delhi, India and love travelling, playing badminton and spending quality time with kids and family.
I hope people will remember me as someone who helped them achieve their potential OR acted as a catalyst to initiate this journey.