Manufacturing & Quality
Uncompromising Standards From Formulation to Finished Product
The quality of a finished product is inseparable from the quality of the process that produced it. We take manufacturing standards seriously — because a formulation that does not meet its specification on the shelf is not the product we designed.
Our Approach
Identifying the Right Manufacturing Partners
WellThesis does not manufacture its own products. Instead, we identify and work with premium contract manufacturing partners who can produce our formulations to the standards required by our design briefs and target markets.
Selecting a manufacturing partner is one of the most consequential decisions in bringing a health product to market. A partner’s quality systems, testing capabilities, documentation practices, and regulatory compliance directly determine whether the product a consumer receives matches the product that was designed.
We have established a comprehensive set of baseline requirements that manufacturing partners must meet or demonstrably be working toward. These requirements are not aspirational — they represent the minimum standard we consider appropriate for biotic formulations targeting health-conscious consumers in regulated markets.
We recognise that different product categories — capsules, powders, sachets, liquids — and different target markets carry different specific requirements. The baseline below reflects our general standards; category-specific requirements are discussed during the partner qualification process.
Baseline Standards
Baseline Partner Requirements
The following requirements apply to all manufacturing partner engagements. Requirements are evaluated during initial qualification and reviewed on an ongoing basis.
Current Good Manufacturing Practice (cGMP)
Compliance with applicable cGMP regulations in the manufacturing jurisdiction — including documented quality systems, trained personnel, and validated processes.
Facility Registrations & Certifications
Relevant facility registrations with national or international regulatory bodies (e.g. FSSAI, US FDA, EU GMP certification) appropriate to the product category and target markets.
Identity Testing
Verified identity of all active and excipient ingredients using appropriate analytical methods — including botanical identification, microbial strain confirmation, or chemical characterisation.
Purity & Contamination Screening
Systematic testing for heavy metals (lead, arsenic, cadmium, mercury), pesticide residues, solvent residues, and other relevant contaminants to limits appropriate for the product category.
Potency Testing
Quantitative verification of active ingredient levels at manufacture — and at end of shelf life — against specification, using validated analytical methods.
Microbial Testing
Testing to established limits for total aerobic plate count, yeast and mould, and specified pathogens (E. coli, Salmonella, Staphylococcus aureus, etc.) appropriate to the product and format.
Stability Testing
Real-time and/or accelerated stability data demonstrating that product meets specification throughout the claimed shelf life under defined storage conditions.
Certificate of Analysis (COA) Management
Comprehensive, accurate COAs for every batch — covering all tested parameters, test methods, results, specifications, and acceptance/rejection status.
Batch Traceability
Full traceability from finished product batch back to raw material lots — enabling efficient investigation and recall procedures in the event of a quality concern.
Quality Systems & Documentation
Documented quality management systems including SOPs, deviation and CAPA procedures, change control, and internal audit programmes.
Deviation & CAPA Procedures
Formal processes for identifying, documenting, investigating, and correcting manufacturing deviations, with root cause analysis and preventive action documentation.
Scale-Up Capability
Demonstrated ability to scale validated formulations from development batch to commercial production volumes without compromising product quality or specification.
Confidential Formulation Handling
Robust information security and confidentiality protocols for proprietary formulation data, including segregation of client formulations and appropriate NDA infrastructure.
International Shipping & Export Capability
Experience with the documentation, labelling, and regulatory requirements for exporting finished products or bulk materials to international markets.
Responsible Sourcing
Transparency about ingredient and raw material supply chains, including sustainability credentials, ethical sourcing commitments, and supplier qualification practices.
Requirements Vary by Product Category and Target Market
The requirements listed above represent our general baseline. Specific product categories carry additional technical requirements — for example, probiotic formulations require cold-chain capability and viable count verification at end of shelf life; powder and sachet formats have specific blending homogeneity requirements; and encapsulated products may require enteric coating validation.
Target market regulatory requirements vary significantly. Manufacturing for the Indian market is governed by FSSAI regulations; export to the EU, UK, or North America involves additional compliance obligations that we discuss with partners as part of the qualification process.
If you are a contract manufacturer and would like to discuss whether your capabilities align with our requirements, we encourage you to submit your information using the link below.
Work With Us
Submit Your Manufacturing Capabilities
If your facility meets or is working toward these baseline requirements and you have experience with biotic or nutraceutical product manufacturing, we would like to hear from you. We review all capability submissions and respond to those that represent a potential fit.